From The Stage

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

Posted by / / Immunogenicity, Industry Update

The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several needed revisions and clarifications. Our own immunogenicity expert, Dr. Arno Kromminga, outlines the significant updates made.

Proof of Concept to Solution: A Unique Approach to Anti-PEG Antibodies Assessment

Posted by / / BioAgilytix Insight, Immunogenicity

BioAgilytix recently had the opportunity to work on a particularly difficult clinical phase anti-drug antibody (ADA) assessment for an innovative PEGylated drug therapy designed to treat a serious chronic condition. Jeff Sailstad, our USA Chief Scientific Officer, explains how our team approached the unique challenges of this assessment.

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Posted by / / Biosimilars, Immunogenicity

Immunogenicity assessments are a critical component to determining the comparability of an originator drug and a biosimilar. It is necessary to determine both neutralizing and non-neutralizing antibody incidence for an originator drug and a biosimilar, and understand the immunogenicity’s impact on PK results as well as its association with adverse events.

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars

Posted by / / Biosimilars, Immunogenicity

An increasing number of patents for originator biologic products are due to expire, and therefore opportunity within the industry to develop additional biosimilars is growing. In response, more pieces of relevant guidance are being developed, and the increased knowledge being gained by the industry as a whole will continue to inform best practices in evolving biosimilar development processes, including those for immunogenicity testing. According to most recent FDA and EMA guidances, a biosimilar is a biological product that is highly similar to an already authorized original biological medicinal product (reference…

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

Posted by / / Immunogenicity

The human body naturally produces antibodies to attack any potentially harmful foreign molecule. However, these antibodies cannot always tell which molecules are actually damaging invaders and which are complex drugs designed to treat life-threatening diseases. Antibodies that mistake a drug as something harmful attach to the drug and render it useless in treating the intended disease. Scientists and physicians struggle with counteracting this natural reaction because not all patients have the same immune response. The consequences of this lack of immunogenicity data appears across disease states, ranging from ineffective treatment…

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors

Posted by / / Immunogenicity, Industry Update

Lung cancer quickly became the most common cancer worldwide in the last decade of the 20th century due to an increase in smoking rates. 1.8 million patients were diagnosed with the disease in 2012, and in the same year 1.6 million patients died from this cancer (1). However, in the last three decades milestones in treating both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) have been met and then improved upon or superseded. The first significant milestone in treating this disease came from combination chemotherapy for…

Considerations to Set ADA Cut Points

Posted by / / BioAgilytix Insight, Immunogenicity

Cut points are the threshold values for the distinction of positive and negative results in immunogenicity assays. Establishing appropriate cut points is crucial to ensuring acceptable assay sensitivity, and, although there are assay-specific characteristics to be considered when setting the cut point, some fundamental aspects should be considered when setting cut points in immunogenicity assays. 1. Statistical Methods Cut points should be calculated applying newest statistical tools using samples from treatment-naïve subjects to obtain robust numbers and take the variability of the assays into account. The cut point should be…