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Author: Nicola Ellis

Autoimmune diabetes is often misunderstood, misdiagnosed, or detected later than it should be. The key to identifying it early lies in specific autoimmune markers, particularly anti-Glutamate Decarboxylase (GAD), anti-Protein Tyrosine Phosphatase-like Protein IA-2 (IA-2), anti-Zinc transporter 8 (ZnT8), and anti-insulin autoantibody (IAA). These lab tests help doctors determine whether high blood sugar is caused by immune destruction of pancreatic beta cells rather than insulin resistance alone.

 

What Is Autoimmune Diabetes?

Autoimmune diabetes occurs when the immune system mistakenly attacks insulin-producing beta cells in the pancreas. This process underlies:

  • Type 1 diabetes
  • LADA (Latent Autoimmune Diabetes in Adults),  a slower, adult-onset form, often misdiagnosed as Type 2 Diabetes because, for a period, these patients still produce insulin but at an insufficient level.

Unlike Type 2 diabetes, the root issue is loss of insulin production, not just insulin resistance.

 

Autoimmune Diabetes is increasing and often misunderstood

Some statistics:

  • Prevalence of Type 1 diabetes varies globally from 3.5:10,000 in Africa to 12.2:10,000 in the USA and is increasing at an estimated 3–4% per year in Europe.1
  • The prevalence of LADA in a population of Type 2 Diabetes Mellitus patients is between 4% and 12%.2

Delayed diagnosis of Autoimmune Diabetes allows blood sugar levels to remain high, which can lead to severe, life-threatening complications, most notably Diabetic Ketoacidosis (DKA). A delayed LADA diagnosis often means the patient is wrongly treated for Type 2 diabetes, failing to receive essential insulin. Detecting this difference early changes treatment decisions and long-term outcomes.

As LADA can easily be confused with Type 2 Diabetes Mellitus, and it’s essential to diagnose autoimmune diabetes as early as possible, is there a case for increased testing of a panel of autoimmune markers?

 

Immunologic Targets Driving Assay Development

Anti-Glutamate Decarboxylase (GAD), anti-Protein Tyrosine Phosphatase-like Protein IA-2 (IA-2), anti-Zinc transporter 8 (ZnT8), and anti-insulin autoantibody (IAA) are all proteins produced as a result of immune dysregulation that target pancreatic beta cells. They have different modes of action and value as diagnostic markers.

Doctors should consider these tests when a diabetes diagnosis is unclear. These tests can help confirm Type 1 diabetes or LADA. A LADA diagnosis should be considered if a patient is not overweight, has a personal/family history of autoimmune diseases, and shows a rapid decline in glycaemic control despite following a type 2 diabetes management plan. They are often positive for GAD and ZnT8.

 

Glutamate Decarboxylase (GAD/ GAD65) Antibodies

This is the highest prevalence autoantibody in autoimmune diabetes. These antibodies target the glutamic acid decarboxylase enzyme, triggering an immune response that destroys insulin-producing pancreatic beta cells. Here are some features that make it an interesting marker:

  • Dominant marker in adult-onset autoimmune diabetes (LADA).
  • It can remain detectable for years making it ideal for retrospective and longitudinal studies.
  • There is strong evidence of immune-mediated diabetes, essential for screening assays and multiplex panels.

 

IA-2 Autoantibodies

Associated with active beta-cell destruction by targeting a beta-cell protein involved in insulin secretion, this marker appears closer to disease onset and correlates with faster progression to insulin dependence.

  • IA-2 autoantibodies would be crucial in a panel that was looking to predict the transition to insulin dependence.

 

Insulin Autoantibodies (IAA)

Often the first antibody detected, especially in paediatric cases, IAA binds to insulin, forming immune complexes that cause erratic blood sugar levels. It is a useful marker because:

  • It helps identify early autoimmune diabetes, so is key for developing early-disease detection assays.
  • Important in neonatal/early-onset cohorts.

It is important to note that post-exogenous insulin exposure confounds measurements, so it is most informative and best measured before insulin therapy starts.

 

Zinc transporter 8 (ZnT8 / a-zinc) Autoantibodies

ZnT8 autoantibodies target the ZnT8 protein located on the membrane of insulin secretory granules in beta cells. By destroying the beta cells, anti-ZnT8 causes a decline in insulin secretion.

  • It improves detection when GAD/IA-2 are negative, increasing overall diagnostic sensitivity, making it useful for uncovering “seronegative” autoimmune cases that may otherwise be missed. When the ZnT8 antibody is tested along with the 3 other T1DM autoantibodies, autoimmunity detection rates were up to 98% in new-onset T1DM cases.3

 

Why Test Multiple Antibodies?

Result Meaning
1 antibody positive Autoimmune diabetes possible
2+ antibodies positive Strong evidence of autoimmune diabetes
Different antibody patterns Help estimate stage & speed of progression

As each marker appears at a different stage of disease, testing multiple markers and combining the data improves the accuracy of the diagnosis and provides doctors with valuable information to guide treatment decisions and insulin timing.

 

Important Companion Tests

Marker Application
C-peptide Correlates autoantibody status with functional beta-cell loss, measuring how much insulin the body still makes. Low or declining C-peptide is indicative of beta-cell failure, therefore distinguishing Type 1 diabetes/ LADA from Type 2 diabetes. It can help decide when insulin is needed and track disease progression.
HbA1c & glucose Confirm diabetes and severity. Used to monitor diabetes management and glycaemic status.
Islet Cell Antibodies (ICA) An older, indirect test for autoimmune diabetes that is less specific than modern markers discussed earlier in the article. It is sometimes included for completeness.
Proinsulin Elevated levels can indicate Beta-cell stress. Is typically used in research or speciality cases.

 

Is It Time for Broader Access to Autoimmune Diabetes Testing?

Current tests for these more specialised autoimmune markers are often Research Use Only (RUO) and testing is typically performed in large reference labs using validated ELISA/ immunoassay methods.

Early detection has been shown to prevent hospitalisation and life-threatening conditions. Screening for Type 1 Diabetes will help people maximize their opportunities to delay Type 1 Diabetes onset while preparing for diabetes care.4  Understanding these markers transforms how diabetes is classified, monitored, and treated and is especially useful in adults who don’t fit neatly into “Type 1” or “Type 2” diagnostic buckets.

 

References

  1. M Popoviciu et al. Type 1 Diabetes Mellitus and Autoimmune Diseases: A Critical Review of the Association and the Application of Personalized Medicine. J. Pers. Med. 2023, 13(3), 422; https://doi.org/10.3390/jpm13030422
  2. V Rajkumar et al. Latent Autoimmune Diabetes. National Institute of Medicine. March 1, 2024. https://www.ncbi.nlm.nih.gov/books/NBK557897/
  3. Maniattu et al. Latent Autoimmune Diabetes of Adults Due to Positive Zinc Transporter 8 Antibody. Annals of Internal Medicine: Clinical Cases, 2025. Vol 4, Number 6. https://doi.org/10.7326/aimcc.2024.1092
  4. D Moore et al. Recommendations for Screening and Monitoring the Stages of Type 1 Diabetes in the Immune Therapy Era. Int J Gen Med. 2024 Jul 9;17:3003–3014. https://doi.org/10.2147/IJGM.S438009

Blog Overview

February 18th 2026
Autoimmune Diabetes
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HAMA-Time! – How Human Anti-Mouse Antibodies (HAMA) can affect your immunoassay
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HAMA is an acronym for Human Anti-Mouse Antibodies. Some humans produce HAMA and have it present in their blood. Unfortunately for them, and the in vitro diagnostics industry, the presence of Human anti-mouse Antibodies (HAMA) in patient samples can lead to false positive and false negative results in immunoassays.
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Logical Biological, biospecimen and critical raw material leader, and Bcell Design, pioneers in transgenic monoclonal antibody technology, today announced a long term strategic partnership to deliver engineered disease state materials for diagnostic and research markets.

 

Working together, the two companies will develop customised engineered disease state and ‘spiking’ materials to deliver compelling alternatives to native disease state plasma. Materials are designed and formulated to bring native disease state plasma-like performance, aligned and customised to customer’s performance and scale requirements.

 

Bcell Design is a leading manufacturer of high-quality, human Fc antibodies using a proprietary platform technology. These antibodies are designed to replicate performance of native disease state plasma, and are already used in FDA approved and CE marked platforms by top 10 IVD companies.

 

Logical Biological brings deep expertise in sourcing, processing and providing biological specimens and bulk disease state plasma, alongside custom plasma processing and protein purification capabilities through sister company Logical Antigen. The company is already supplying native disease state plasma and customised critical raw materials at scale to the largest QC calibrator and control manufacturers.

 

Disease state plasma is a key component for IVD calibrators and controls, assay development and quality control testing. However, human disease state materials can be difficult to reliably and consistently source. To solve this challenge, engineered materials are formulated with Bcell Design’s patented human Fc monoclonal antibodies to mimic disease state plasma. This provides multiple benefits – including reproducibility and long-term supply sustainability – whilst maintaining high performance levels and offering benchmarking against native plasma samples.

 

The strategic partnership will focus on IgM and IgG engineered disease state material for challenging to source materials, including Rheumatoid Factor (RF). By the end of 2025, the companies expect to have well characterised products for ToRCH, infectious diseases and other conditions.

 

Léone Atayi, Chief Executive Officer at Bcell Design, commented: “The diagnostics sector faces increasing challenges in securing reliable and sustainable sources of disease state materials. By joining forces with Logical Biological, we are combining complementary expertise in antibodies and plasma materials to deliver sustainable, high-performance diagnostic solutions in key therapeutic areas—supporting earlier and more accurate disease detection worldwide.”

 

Stephane Argivier, Chief Executive Officer at Logical Biological, said: “This strategic partnership will unlock new opportunities and address sustainability for the diagnostics sector. By replicating critical plasma performance characteristics and providing comprehensive performance data, our engineered disease state materials aim to match native plasma performance whilst providing supply security and consistency in specific applications. Building on our bulk purification and disease state material expertise, we’re excited to partner with Bcell Design to help our customers resolve today’s challenges and bring tomorrow’s innovation.”

 

This unique end-to-end solution addresses the requirements of the largest users of native disease state materials, aiming to deliver engineered alternatives with long term supply sustainability and consistency at scale. With bespoke products, the partnership is able to meet customer specifications with extensive testing on multiple platforms and dilutions levels.

 

To learn more about how engineered disease state materials can strengthen quality control manufacturing, visit: www.logicalbiological.com/engineered-disease-state-plasma/

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September 10th 2025
Company News Quality Controls
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Understanding the challenges of obtaining high-titre materials

High-titre biological materials play a vital role in the development and manufacturing of in vitro diagnostic (IVD) controls and calibrators. These materials are essential for accurate and reliable diagnostic tests – a crucial part of patient care and treatment decision-making. However, sourcing bulk high-titre disease state materials presents significant challenges for Quality Control and Calibrator Manufacturers. These obstacles impact downstream processes for IVD companies, and more importantly, the patients who awaiting testing, diagnosis, and treatment.

 

To better understand the challenges, their impact, and potential solutions, we spoke to Brian Fernandez, Biotech Consultant-IVD Specialist, and Andrew Conner, Procurement Director at Logical Biological. Read on to explore their perspectives and practical solutions for those working in the IVD procurement and supply chain sector.

 

Why are high-titre materials becoming harder to source?

“In R&D, you need everything from negatives to high positives to validate an assay. But in manufacturing, the goal is reliability: a consistent, secure supply chain to meet mid-term needs.” Andrew told us. This contrast underscores the sourcing challenges bulk manufacturers face in a regulatory and operational landscape that demands consistency over variation.

 

However, several factors are making sourcing high-titre biological materials more challenging to collect:

  • Advances in treatment reduce availability: Improved medical treatment has created a paradox for the IVD industry. While these improvements benefit patients, they also diminish the presence of key biomarkers in the population. For example, rheumatoid factor (RF) and antibodies linked to infections like human immunodeficiency virus (HIV) and hepatitis C virus are suppressed in many treated individuals, making high-titre samples harder to find.
  • Short-lived antibodies narrow the collection window: Antibodies such as immunoglobulin M (IgM), crucial for detecting early-stage infections, appear transiently and typically decline after seroconversion to immunoglobulin G (IgG). As Andrew explained: “By the time someone seeks care, the IgM window may have already passed. That makes pinpointing this phase more opportunistic and uncertain.”
  • Geographical and ethical constraints: Some disease-state materials, like HIV-2, are predominantly found in specific regions such as West Africa. This geographic limitation, coupled with the need for ethical, consent-based sourcing, narrows the available pool. Many countries restrict or prohibit compensated donation, but this adds another layer of complexity for global procurement. As Andrew mentioned, “You need that outreach to find active infections at different levels, and that often means looking beyond Europe and North America. However, it has to be regulated, consented, and equitable, especially when vulnerable populations are involved.“
  • A quality-first manufacturing culture: Manufacturers often exercise caution when switching suppliers or materials, especially under stringent regulatory frameworks. Minor adjustments like blending or spiking to meet titre levels can trigger validation requirements, which increase both time and cost.

 

Bench to bedside: The impact on Control and Calibrator Manufacturers, HCPs, and patients

The scarcity of high-titre materials directly affects Control and Calibrator Manufacturers, healthcare providers (HCPs), and ultimately, patients.

 

Production delays and rising costs: Scarcity of high-titre materials leads to smaller batch sizes, escalating costs per unit and complicating planning cycles.

 

Brian Fernandez, an experienced professional in the control and calibrator space, shared the challenges he faced first-hand:

“I recall running into difficulties sourcing disease state plasma for RF, antistreptolysin O and total immunoglobulin E quite frequently. The result is that we would adjust our bulk sizes down to accommodate, which could have supply issues with our finished products. In the worst-case scenario, even with drastic volume reductions, we couldn’t reach our intended high-level target. That not only put us at risk of releasing a non-conforming finished good, but also meant that end users lacked quality control materials capable of truly challenging the upper dynamic range of their assays.“

 

This real-world example illustrates the delicate balance procurement teams must maintain between availability, quality, and regulatory compliance.

 

Quality assurance and regulatory hurdles: Regulators often mandate that controls represent native patient samples. Shifting to synthetic materials is a long-term consideration, but not always viable in the short term. “Everyone knows these native materials are getting harder to source. The real question is: when do we move toward synthetic — and are we ready to validate that shift?”, added Andrew. Subsequently, manufacturers may find themselves forced into suboptimal interim solutions.

 

Patient impact: Disruptions in quality control can result in delayed or inaccurate diagnoses, affecting patient care. For clinicians, this means uncertainty, while for patients, it can mean delays to treatment.

 

The Logical Biological difference

At Logical Biological, we are committed to being a trusted partner in sourcing sustainable, high-quality biological raw materials for control and calibrator manufacturing.

Global outreach

Our extensive and growing network currently spans 45 clinical collection sites across five continents, providing access ethically to a diverse range of materials. As Andrew noted, “Certain infections appear only in specific regions. Without a global network, you’re cut off from that biology, full stop.”

Quality assured

We prioritise a rigorous onboarding process for new collection centres, including regulatory vetting, quality assessments, and donor consent protocols.

Ethically obtained

We ensure ethical material collection practices by ensuring all collection centres have the necessary documentation.

Secure supply chain

Our logistics partners maintain high standards, using temperature-controlled shipping methods to preserve sample integrity during transportation and ensure high-titre materials remain free from bioburden.

Meeting evolving demands

Market requirements evolve rapidly, and demand can change overnight. As Andrew noted, “We track historical trends, so when we see a spike, like dengue recently, we’re not surprised we’re ready.” Our approach allows us to evaluate feasibility within 48 hours, developing comprehensive plans from 7–14 days.

Exceptional service

Through proactive planning with our clients, we offer clear communication on feasibility, logistics, and lead times. Our collaborative approach benefits every stakeholder by bringing the right expertise to bear on a customer challenge.

 

Logical Biological: A reliable, global partner in a complex market

Sourcing high-titre biological materials is a difficult but essential process. Our global network makes us a reliable partner for sourcing high-quality material. It means we can address both current and future customer demands while meeting both operational and regulatory requirements with confidence.

 

Contact us if you are facing challenges with sourcing high-titre or rare biological materials, or to discuss how we can support your business.

Blog Overview

May 21st 2025
Opinion Quality Controls
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When it comes to manufacturing quality controls (QCs), choosing the right raw material is essential. Controls need to be accurate, reliable, consistent, and closely mimic real patient samples. But with factors like supply consistency and sustainability, cost, stability, and performance to be considered, how do you decide whether a native or engineered biological raw material is best? This article explores the advantages, disadvantages, and provides expert insights on selecting the best approach for quality control development.

 

Understanding Native and Engineered Raw Materials

Native Biological Raw Materials

Native raw materials are biological substances derived from humans or extracted from human-based materials such as native antigen extracts, tissues, cells, blood, serum, plasma, and other bodily fluids. These materials undergo minimal processing to preserve their functional integrity, making them highly relevant in research, therapeutic applications, and diagnostic testing.

Examples of Native Materials:

  • Defibrinated human disease state plasma processed to resemble serum.
  • Natively derived biofluids (e.g., serum, plasma) formulated with purified native analytes like proteins, enzymes, or antibodies to achieve required concentrations.

Engineered Biological Raw Materials

Engineered raw materials are biological substances designed to mimic or enhance the functionality of native biological counterparts. They are produced using molecular biology techniques and can offer advantages in terms of stability, scalability, and purity.

Examples of Engineered Materials:

  • Engineered plasma or serum matrices made from buffers, polymers, or animal-derived components.
  • Recombinant proteins (e.g., antigens, enzymes, engineered/ recombinant antibodies) produced via genetic engineering.
  • Modified biomolecules incorporating chemical cross-linking to achieve desired performance or enhance stability.

 

Evaluating Native vs. Engineered Raw Materials: A Comparative Analysis

To support informed decision-making, the following provides a comparative analysis outlining the advantages and disadvantages associated with native and engineered raw materials:

Feature Native Raw Materials Engineered Raw Materials
Biological Relevance High, often more commutable with patient samples May differ from native samples, depending on complexity
Functionality Maybe superior for complex multimeric proteins, cofactors, and post-translational modifications May lack certain native functionalities, but can be optimised
Lot-to-Lot Consistency Natural variability due to biological differences High consistency across batches
Scalability Limited, depends on biological sourcing More easily scalable for high production volumes
Risk of Contamination Potential for human pathogens and biological contaminants Lower contamination risk, free from human pathogens
Ethical Considerations Ethical considerations when sourcing from human donors, particularly high-titre materials from patients No human donor concerns
Stability & Purity Variable stability and risk of degradation if not stored properly Generally, more stable and higher purity
Cost & Availability Can be cost-effective but may be limited by supply Expensive to develop but offers greater availability
Development Time Readily available providing access to suitable donors is sustainable Longer initial development and scale-up time

 

Expert Insights: Native Materials and Their Unique Advantages

One of the most critical factors when selecting raw materials for quality controls is ensuring that they mirror actual patient samples in their response to assay system changes. Experts note that native materials often provide better commutability, meaning they exhibit similar shifts and biases to patient samples when instrument performance, reagents, or calibrators change.

One of our industry experts shared an example where a human-derived cholesterol control detected an assay issue, while an animal-derived control failed to flag the problem. This highlights a key benefit of using native materials—ensuring that quality control samples respond to system variations in the same way as real patient samples.

However, native materials present several challenges, including biological variability, limited scalability, and potential contamination risks. Some complex proteins, such as haemoglobin tetramers and various growth factors, require precise folding, complex subunit assembly and/or post-translational processing, which can be difficult to replicate outside of the natural host organism.  While synthetic biotechnology techniques continue to improve, some proteins are still best sourced through their native sources.

 

Engineered Materials: Achieving Consistency and Scalability

Engineered and recombinant materials provide greater consistency and scalability, making them attractive alternatives when native materials are costly or difficult to obtain. Recombinant proteins and engineered matrices eliminate pathogen risks and offer batch-to-batch consistency.

However, some engineered raw materials lack key post-translational modifications (PTMs) or require complex folding that native systems inherently achieve. Certain recombinant antibodies, for instance, may not perfectly replicate the native structure due to difficulties in assembling heavy and light chains with correct disulphide bonds. Mammalian expression systems can mitigate some of these issues but add to production costs and complexity.

 

Making the Right Choice: Practical Considerations

Functionality vs. Feasibility

  • If functional integrity and biological relevance are the top priorities, native materials may be preferable.
  • If lot-to-lot consistency and large-scale production are essential, engineered materials should be considered.

Cost and Supply Constraints

  • Native materials may be cost-effective when high-titre sources are available but can be limited in supply.
  • Engineered materials often require high initial investment but ensure consistent availability in the long run.

Testing in Feasibility Studies

A practical approach maybe to evaluate both native and synthetic options during feasibility studies. As one industry expert advises:

“I believe there is still a perceived superiority of native materials in quality control development. However, if engineered options provide cost or availability advantages, I will include them in my feasibility studies and assess their performance. Sometimes, engineered options can outperform native materials in cost effectiveness, availability, and even performance!”

 

Conclusion: Striking a Balance Between Native and Engineered

The decision between native vs. engineered raw materials depends on a careful balance of biological relevance, scalability, and cost. While native materials often provide superior functionality and commutability, engineered materials offer greater consistency, scalability, and reduced contamination risks.

The debate between native and engineered raw materials will likely continue, but by understanding their strengths and limitations, QC manufacturers can make informed decisions. Whether you’re using native or engineered biological raw materials, the right choice depends on your specific needs and the parameter being tested.

Blog Overview

March 19th 2025
Opinion Quality Controls
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Understanding the Challenges of Quality Control Manufacturers

IVD manufacturers face a range of challenges when sourcing biological raw materials. Each manufacturer has unique requirements based on the specific assays and controls they produce, making the selection process highly nuanced. The need for consistent, scalable, and high-quality raw materials is critical, yet these attributes can be difficult to guarantee due to the inherent variability of biological sources.

Lot-to-lot consistency ensures that Quality Control (QC) manufacturers can maintain consistent analyte target concentrations in their products, facilitating smooth validation processes and ensuring regulatory compliance. This article explores the key considerations for QC manufacturers in achieving lot-to-lot consistency when utilising bulk biological raw materials.

 

The Importance of Lot-to-Lot Consistency

For a QC manufacturer, obtaining multiple samples across multiple lots of raw material is critical for qualification and validation purposes. The primary concerns include:

  • Consistent Analyte Values: QC manufacturers must ensure that each lot of material maintains expected analyte concentrations, enabling laboratory personnel to perform accurate patient testing. Variability in analyte values can result in regulatory challenges and usability issues.
  • Reliable Availability: Uninterrupted supply of biological raw materials ensures that QC manufacturers can meet demand and avoid backorders due to material rejection.
  • Scalability: As QC manufacturers expand their market share, the ability to scale raw material supply without compromising quality is crucial.

 

Requirements for Raw Materials

Lot-to-Lot Consistency

Ensuring lot-to-lot consistency is essential to maintaining QC product performance. Variability in raw material specifications such as titre, analyte concentration, and pH can lead to significant manufacturing disruptions. If a batch of raw material falls outside of predefined specifications, it can result in product rejection, requiring costly deviations and re-validations.

Raw material suppliers must implement validated manufacturing processes to guarantee uniformity. By maintaining strict quality controls, suppliers help QC manufacturers achieve seamless transitions when onboarding new lots of control materials.

Reliable Supply Chain

A dependable supply chain is vital for ensuring that QC manufacturers receive raw materials in a timely and stable manner. Delays in raw material shipments can cause backorders, disrupting production and impacting end users. Global shortages of certain biological materials have, in the past, forced manufacturers to implement deviations or retrospective validations—costly challenges that highlight the importance of a supplier with robust inventory management and production planning.

Scalability and Growth

As QC manufacturers expand their market share, their need for increased raw material volumes grows. A supplier’s ability to scale production in tandem with demand is an important factor. Without the capacity to meet growing requirements, manufacturers may face interruptions or be forced to qualify alternative materials mid-production—an expensive and time-consuming process. Scalability ensures manufacturers can confidently plan for future needs without compromising product integrity.

Certificate of Analysis and Stability Testing

A comprehensive Certificate of Analysis (CoA) that includes testing of critical parameters is an essential requirement for QC manufacturers. This ensures that each lot meets established specifications and reduces the risk of unexpected performance issues.

Biological raw materials must maintain stability over time to ensure consistent performance. Real-time stability testing assesses parameters such as titre, activity, concentration, and microbial contamination over a defined shelf-life. If materials degrade over time or accumulate contaminants, they may no longer be suitable for QC applications, leading to batch rejections, customer complaints, backorders, patient safety issues, and increased costs.

Sampling and Retain Program

QC manufacturers benefit from suppliers who implement robust sampling and retain programs. These programs serve multiple purposes:

  • Design and development validation: While raw materials are not typically subject to the same stringent design controls as medical devices, they must undergo validation to support product claims.
  • Validation Processes: At least three lots of raw materials are typically required for design and process validation, making access to multiple retained lots a significant advantage.
  • Troubleshooting: Retained samples enable QC manufacturers to investigate and resolve potential issues efficiently.

 

Technical Considerations for Quality Control Manufacturers

Certain technical challenges can complicate the use of biological raw materials in QC applications. Understanding these issues helps manufacturers make informed decisions.

Protease Activity and Analyte Stability

Protease activity can degrade sensitive analytes in many QC materials. It may originate from microbial contamination and may persist despite efforts to eradicate, neutralize or filter out the microbes. Proteases may also arise from endogenous sources from delayed or improper processing leading to lysis of cells prior to the separation of the plasma/serum component.  Once active, these enzymes can reduce analyte stability and compromise test accuracy.

Albumin Conformation and Stability

Denatured or partially denatured albumin is a lesser-known but significant problem in serum-based products. The three-dimensional structure of albumin plays a crucial role in maintaining analyte stability. Exposure to heat, pH shifts, or denaturing compounds like urea, guanidine or organic solvents, can alter this structure, causing analytes to bind unpredictably. Partially denatured albumin may bind analytes such as hormones, peptides, and enzymes, causing analyte loss and inconsistencies in QC products. Even slight misfolding can lead to assay discrepancies across different instrument platforms, making consistent albumin conformation a critical consideration.

Co-Morbidities in Disease State Materials

Disease state materials often contain a complex mix of cross-reactive antibodies, which can lead to unexpected interferences in QC manufacturing. Ensuring that disease state specimens meet specific inclusion criteria is essential to maintaining product reliability.

Inactivation Processes and Their Trade-Offs

Some inactivation processes, such as heat treatments used to eliminate proteases, can have unintended consequences. While effective at reducing protease activity, these treatments may also denature critical proteins, reducing marker titres and affecting overall performance. Understanding the impact of inactivation techniques on raw material integrity is key to selecting suitable specimens.

 

The Value of Validated Processes

Robust processes that preserve biological raw material integrity are essential for ensuring consistent, reliable performance of QC manufacturers controls and ensuring commutability across different instrument platforms. Selecting the right raw material from the outset minimises the need for costly reformulations and process deviations.

At Logical Biological, we are committed to working closely with our customers to define customised specifications that deliver the performance and consistency their applications demand. Our vision is to provide Insightful Solutions that Make a Difference—ultimately contributing to Improved Health Outcomes.

To turn this vision into reality, we have made significant investments over the past year, in new, expanded state-of-the-art laboratory space, broadening our R&D capabilities, and scaling up our processes and operations. These advancements strengthen our ability to support Quality Control and IVD Assay manufacturers with a sustainable, high-quality supply of critical biological raw materials—ensuring they can meet both operational and regulatory requirements with confidence.

Blog Overview

February 17th 2025
Quality Quality Controls
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Logical Biological and Bcell Design Announce Strategic Partnership for Engineered Disease State Materials
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Calprotectin is a heterodimer protein expressed by leucocytes and used as a biomarker for Inflammatory Bowel Disease (IBD). It is packed into granular neutrophils (up to 60% of cytoplasmic protein) and released by shedding, active secretion, or cell death. Calprotectin is present in IBD patients because it is expressed by leucocytes that have accumulated in the gastrointestinal tract as part of the inflammatory response and is therefore present in the faeces when intestinal inflammation occurs.

Why measure Calprotectin?

The use of Calprotectin screening has dramatically altered diagnosis of IBD diseases, such as Crohn’s disease and ulcerative colitis. It is considered a reliable marker because it is resistant to degradation and samples can be kept for up to 5 days without affecting tests or results. Calprotectin can be used as a screening tool to differentiate between IBD and Irritable Bowel Syndrome (IBS) and prevent unnecessary endoscopies for patients with low Calprotectin levels. This is a relief to most and makes significant cost savings for healthcare payors, however an endoscopy is still recommended to diagnose patients with suspected IBD based on the UK, Canadian, World and US Gastroenterology Organization guidelines. With an increasing amount of young people, and children being diagnosed with IBD alternatives to invasive tests are vital.

If a patient presents with symptoms of lower abdominal pain, it is important to ascertain between a range of illnesses. Early symptoms of IBD are very similar to IBS. A short list of associated symptoms include:

  • Abdominal pain and discomfort
  • Irregular bowel movements
  • Irregular bowel consistencies
  • Nausea
  • Bloating

If IBD progresses bleeding, anaemia, weight loss and fever can occur. The causes of IBD versus IBS are very different and differentiating between the two is important for patient care.

Calprotectin tests

Calprotectin levels can be measured through faecal sampling via a variety of testing methodologies. From rapid immunochromatographic (also known as lateral flow) tests, enzyme-linked immunosorbent assays (ELISA), and automated immunoassays, there are tests to suit all situations, from home testing to larger scale laboratory testing. All provide quantitative results, however measurements exhibit variability and no current method is universally accepted as a standard.

 

The reference ranges for calprotectin levels can vary slightly between different laboratories and assay methods and each manufacturer sets their own cut-off values for IBD and IBS differentiation. Calprotectin Stool samples In the UK, many hospitals are using the New Faecal Calprotectin Care Pathway for interpretation of the values obtained from a faecal calprotectin test with the following criteria:

  • <100µg/g = IBD is unlikely
  • 100 – 250µg/g = Intermediate result – Repeat the test in 2 weeks
  • >250µg/g = Likely IBD refer to secondary care

It is important to note that this pathway is based on testing using the Bühlmann assay, with some compatibility testing performed to understand the cut off differences for the Thermo Fisher assay. It is essential that users are aware of which testing option they are utilizing to ensure the most effective outcomes in their chosen care pathways.

Tracking Calprotectin levels throughout the course of an IBD suffered illness is increasingly aiding treatment decisions. The move from lab-based ELISA to home-based lateral flow tests initiated  a study comparing 3 lateral flow tests utilising a smart phone app with known ELISA tests to confirm Calprotectin levels. All three calprotectin home tests and companion ELISAs agreed sufficiently when concentrations were at the high end (≤500 μg/g).

Calprotectin Conclusion

Calprotectin testing has reduced the numbers of endoscopies and colonoscopies required, saving time, money, and patient discomfort. Used in isolation preliminary Calprotectin tests may well have limitations, but in conjunction with full medical history and other diagnostic procedures it is a useful tool to differentiate between IBD and IBS. Using Calprotectin tests throughout the course of a sufferers IBD could help the patient manage their lifestyle and treatments. Aided by the use of smart phone apps that facilitate test readings and can link directly with GP surgeries. International standardisation remains an issue and is something for manufacturer collaboration to resolve.

Logical Biological Products

Logical Biological offers stools/faeces from donors, including those diagnosed with IBD, containing known levels of Calprotectin measured using the Diasorin Liaison test. This material is suitable for many applications including assay development, assay validation, quality controls and External Quality Assurance schemes.

Blog Overview

December 18th 2024
Gastrointestinal Immunoassays Stools
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The Growing Threat of STIs: A Global Perspective
April 18th 2024
Sexually Transmitted Infections (STIs) continue to be a significant global health concern, affecting millions of people each year, irrespective of geographical location or economic status. While the spotlight often falls on diseases like HIV and syphilis due to their severe consequences and historical significance, other STIs such as chlamydia, gonorrhoea, and human papillomavirus (HPV) also pose substantial threats to public health worldwide.
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We are proud to announce the appointment of Stephane Argivier as our new Chief Executive Officer, effective from 1st September 2024. Stephane Argivier will lead the next stage in the company’s expansion and succeeds Dr. James Steggles, the company’s founder, who announces he will remain Chair of the Board.

 

The announcement follows recent company successes in which Logical Biological received prestigious accolades, including securing the 149th spot in the “FT 1000: Europe’s Fastest Growing Companies” listing and a King’s Award for International Trade, recognising 5 years of impressive growth for Logical Biological.

 

Stephane Argivier, former CEO at MIP Discovery, recently renamed as Tozaro, and previously Managing Director at SCIPAC, now part of BBI Solutions; became Non-Executive Director and member of the Board at Logical Biological in 2021.

 

Stephane Argivier has a successful track record with over 25 years’ experience in growing critical reagent businesses for applications in ‘in-vitro’ diagnostics and Life Science tools. As Managing Director of SCIPAC, he transformed the company’s business model and offering, to achieve broad market adoption of customer centric products. SCIPAC was sold to the multinational BBI Solutions in 2010.

 

Stephane has also played a key role in shaping the Logical Biological strategy to date, which has underpinned its stellar growth.  As a successful Life Science business leader with depth of expertise in clinical biospecimens and the affinity diagnostic reagents market, Stephane is ideally suited to lead a smooth transition, scale the business and lead its ambitious expansion plans.

 

Biospecimen and manufactured bioreagents are critical for R&D, validation, manufacture and QC of diagnostic assays, and yet quality, sustainability and technical support can be a challenge to meet the ever-increasing standards required in ‘in vitro diagnostics’. Logical Biological aims to deliver an unmatched level of quality, expertise and technical understanding of customer applications to address these.

 

Dr. James Steggles, Chair of Logical Biological, said: “We are delighted that Stephane has agreed to become our new CEO. His leadership and expertise will drive Logical Biological forward in its mission to deliver a sustainable supply of critical material solutions to accelerate our customers diagnostic and therapeutic advancements’’

 

Stephane Argivier

Stephane Argivier, incoming Chief Executive, said: “I joined Logical Biological as CEO because I could see the great potential in the company, knowing the value of deep expertise, quality and exceptional customer service to deliver critical and complex bioreagent solutions to the IVD market. In my 4 years with the business as a Board Director, I have been impressed by the quality of our people, know-how and the strength of our client relationships, which provide strong foundations on which to build in the years ahead. I believe we have an exciting future in front of us to expand the business and deliver value for our customers and shareholders.’’

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September 3rd 2024
Company News Industry News
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Logical Biological and Bcell Design Announce Strategic Partnership for Engineered Disease State Materials
September 10th 2025
Logical Biological, biospecimen and critical raw material leader, and Bcell Design, pioneers in transgenic monoclonal antibody technology, today announced a long term strategic partnership to deliver engineered disease state materials for diagnostic and research markets.
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We are proud to announce that Logical Biological has been honoured with the King’s Award for Enterprise. This prestigious award recognises Logical Biological’s excellence in International Trade for Outstanding Short-Term Growth in overseas sales over the last three years (2020-2022), which amounted to a more than one hundred and seventy per cent increase in international revenues during the period. This growth was achieved organically, amidst the challenging circumstances of the COVID-19 pandemic and is a mark of the company’s excellent reputation and unwavering commitment to providing high-quality biological samples to its diagnostic and therapeutic customers.

 

The King’s Awards for Enterprise, previously known as The Queen’s Awards for Enterprise, were renamed last year to reflect His Majesty The King’s desire to continue the legacy of HM Queen Elizabeth II’s by recognising outstanding UK businesses. The Award programme, now in its 58th year, is the most prestigious business award in the country. The awards celebrate the success of exciting and innovative businesses which are leading the way in one of four categories: Innovation, International Trade, Sustainable Development and Promoting Opportunity (through social mobility).

 

“We are delighted to receive the King’s Award for International Trade, which affirms our role as a leader in the global biospecimens market,” expressed Dr James Steggles, Managing Director of Logical Biological. “This award is a testament to the tireless efforts of our team and the trust our customers place in us as their supplier of choice for high-quality biospecimens. Our commitment to excellence not only propels our growth but also significantly furthers our mission to contribute to a healthier world.”

Kings Award For Enterprise International Trade Emblem

Over the three-year period, Logical Biological worked with a record number of customers, including many of the top 10 global leading companies in In Vitro Diagnostics (IVD) test manufacturing. It shipped products to twenty-four countries (including the USA, Germany, South Korea, Ireland, and Australia), and continues to expand its reach globally. The success of Logical Biological on a global scale can be attributed to its comprehensive range of biological samples and its commitment to quality, reliability, customer service, and responsiveness. The company’s deep understanding of the international scientific community’s needs, coupled with its focus on a customer-centric approach and strict quality control protocols, ensure superior product quality and customer satisfaction.

 

Lowri Cope, Commercial Director at Logical Biological, added, “We are immensely proud to be recognized for our outstanding growth in international trade. Our strong relationships within the global In Vitro Diagnostics (IVD) community form the foundation of our success. We are excited to continue this trajectory, expanding our partnerships and enhancing our role in diagnostics and therapeutic research and development.”

 

This recognition is not just an award but a reflection of Logical Biological’s dedication to impacting the global healthcare landscape positively.

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May 7th 2024
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Logical Biological and Bcell Design Announce Strategic Partnership for Engineered Disease State Materials
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Sexually Transmitted Infections (STIs) continue to be a significant global health concern, affecting millions of people each year, irrespective of geographical location or economic status. While the spotlight often falls on diseases like HIV and syphilis due to their severe consequences and historical significance, other STIs such as chlamydia, gonorrhoea, and human papillomavirus (HPV) also pose substantial threats to public health worldwide.

 

STI Trends and Insights

While syphilis and HIV have historically been central to STI discussions, it’s crucial to address the wide spectrum of STIs affecting populations globally. Diseases like chlamydia, often asymptomatic, can lead to infertility if untreated. HPV, the most common STI, is a leading cause of cervical cancer, underscoring the importance of vaccination and regular screenings.

  • Chlamydia: A common STI caused by infection with the bacterium Chlamydia trachomatis. The WHO estimated that in 2020 there were 5 million new infections worldwide among adults aged 15 to 49 years.
  • Syphilis: Despite being one of the oldest known STIs, syphilis cases have surged, particularly in high-income countries, with an increase in Europe of 70% from 2010 to 2017 and cases are still rising with an increase of 34% between 2021 to 2022.
  • Human Papillomavirus (HPV): The WHO estimates that nearly all sexually active individuals will get at least one type of HPV at some point in their lives. Whilst in 90% of people the body controls the infection by itself, persistent HPV infection with high-risk HPV types is a leading cause of cervical cancer.
  • Trichomoniasis: The most common non-viral STI. Caused by the protozoan Trichomonas vaginalis which specifically targets the urogenital tract. There were an estimated 156 million new cases of vaginalis infection among people aged 15–49 years old globally in 2020 with approximately one third of infections in the WHO African Region.

 

Gonorrhoea- An Urgent Threat

Caused by the bacteria Neisseria gonorrhoeae, cases of Gonorrhoea have increased significantly. In the UK whilst there was an increase of 13% in the number of sexual health screens between 2021 and 2022, there was a larger increase in diagnoses of gonorrhoea (50%), which may either reflect more targeted testing of people more likely to have an STI, or an increase in STI transmission in the community. A recent publication from the European Centre for Disease Prevention and Control (ECDC) confirms the worrying trend across Europe with the number of reported cases of gonorrhoea rising by 48% compared to the previous year.

Alongside the increasing incidence is the concern over antibiotic-resistant gonorrhoea which has emerged as a significant public health challenge, with the US CDC identifying it as an “urgent threat” and estimating that there are 550,000 drug-resistant infections per year.

 

The Interconnectedness of STIs and Other Health Risks

The relationship between different STIs can exacerbate health outcomes. For example, genital ulcers from syphilis can increase the risk of acquiring HIV, a phenomenon seen with other ulcerative STIs as well. Two types of HPV (HPV 16 and HPV 18) are responsible for approximately 70% of cervical cancer cases. Moreover, co-infections can complicate treatment and disease management, highlighting the need for comprehensive testing and prevention strategies.

 

The Importance of Comprehensive STI Testing and Prevention

With more than 1 million sexually transmitted infections acquired every day worldwide, the majority of which are asymptomatic, testing is vital to reduce the transmission. Beyond the successful models of HIV and syphilis testing in pregnant women, there’s a pressing need to enhance screening and prevention for other STIs. Approaches include:

  • Expanded Testing: Point-of-care (POC) tests and integrated screening programs to include a broader range of STIs, making it easier to identify and treat diseases early. Increased screening for chlamydia and gonorrhoea has been shown to reduce incidence rates, particularly in high-risk populations.
  • Vaccination: Promoting vaccines, especially against HPV, can significantly reduce the incidence of cervical cancer and other HPV-related diseases. The WHO recommends HPV vaccination for girls aged 9-14 to prevent cervical cancer, with studies showing vaccine efficacy of nearly 100% for certain HPV types.
  • Education and Awareness: Increasing awareness about the importance of safe sex practices and regular testing can help reduce the transmission of STIs.
  • Integrated Health Services: Combining STI screening with other health services can improve access to testing and treatment, especially in LMICs where healthcare resources are limited.

 

Conclusion: A Call for Global Action Against STIs

The data underscores the critical need for a global response to the STI epidemic that encompasses not only HIV and syphilis but also other prevalent infections like chlamydia, gonorrhoea, and HPV. By investing in comprehensive strategies that include education, vaccination, and accessible testing, the global community can make significant strides in reducing the burden of STIs and safeguarding public health.

 

STI Biospecimens from Logical Biological

Logical Biological can provide a wide variety of serum, plasma and swabs for the research and development of STI tests and manufacture of control material. All specimens can be provided according to your custom specifications and are supplied with patient demographic information. A variety of testing methods can be utilised to confirm positivity for the disease marker requested and provide titre values.

Popular products available include:

Marker Matrix
HIV Plasma, Serum
HIV O (Human Immunodeficiency Virus Subtype O) Plasma, Serum
Syphilis Plasma, Serum, Swab, PBMC, Urine
Syphilis IgM Plasma, Serum
Gonorrhoea IgM Plasma
Neisseria gonorrhoeae Swab, Urine, Plasma
Chlamydia trachomatis Swabs, Urine
Chlamydia trachomatis IgA/ IgG/ IgM Plasma, Serum
Trichomonas vaginalis Swab, Urine
Trichomonas vaginalis IgM Plasma
HPV (Human Papillomavirus) Swab
HPV (Human Papillomavirus) IgG Plasma

A full range of infectious disease products available can be found in our product table

Blog Overview

April 18th 2024
Immunoassays Infectious Diseases Point of Care Testing Swabs
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Dual HIV/ Syphilis POC Tests: Their Importance in Low to Middle Income Countries
March 30th 2023
Sexually transmitted infection (STI) cases across the world are an ever present and ever-increasing issue, not only to adults but to a foetus. Two diseases of particular importance are HIV and Syphilis (caused by the bacterium Treponema pallidum).
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HIV-Infections-2020-Source-UNAIDS-WHO

We’re excited to share a milestone in our journey at Logical Biological. Our relentless dedication to customer centricity and unwavering commitment to quality has led to us securing 149th spot in the prestigious “FT 1000: Europe’s Fastest Growing Companies” listing, a recognition that fills us with immense pride and joy.

 

The “FT 1000” list, created in collaboration with Statista, shines a spotlight on the European companies that have shown extraordinary growth. The ranking is determined by analysing the compound annual growth rate (CAGR) in revenue from 2019 to 2022. In a list that is dominated by IT, Software, Construction and Energy/ Utility companies, Logical Biological is proud to be leading the way for science.

 

Our Managing Director, Dr James Steggles, reflects on this achievement with gratitude, attributing it to the hard work of our team and the trust our customers place in us. “This recognition validates our team’s dedication and the close relationships we’ve built with our partners who share our vision of creating a healthier world. It’s their trust in us as a provider of high-quality biospecimens that has propelled our growth.”

FT 1000: Europe's Fastest Growing Companies

Our position in the list is not just a number—it’s a narrative of our dedication to delivering excellence. Our expansive array of biological samples, combined with our focus on responsiveness, reliability, and quality, illustrates our commitment to the scientific community. We strive to understand and meet their needs ensuring that our products and services exceed expectations and maintain the highest quality standards.

 

Lowri Cope, Commercial Director, echoes this sentiment, expressing enthusiasm for our future endeavours. “Being acknowledged as one of Europe’s fastest-growing companies is a milestone that fuels our ambition. We look forward to building on this success and forging new partnerships in the advancement of scientific research and healthcare.”

 

As we celebrate this achievement, we’re not just looking back at our successes—we’re looking forward to the opportunities that lie ahead. Our vision is clear. Join us as we continue to forge ahead, solidifying our role as your trusted partner for biospecimens.

Blog Overview

March 12th 2024
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Logical Biological and Bcell Design Announce Strategic Partnership for Engineered Disease State Materials
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