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Validity : 18th Apr'24 to 28th Apr'24
Immunogenicity to Biologics
- Understanding the impact of immunogenicity
- Understanding expectations for testing for immunogenicity
- Risk-based approach for immunogenicity
- Designing a solid strategy to assess immunogenicity
- Method development strategies
- Validating the methods
- Designing the validation protocol
- Confirmation assays
- Determining an appropriate cut-point
- Data analysis during sample analysis
- Problems and pitfalls to avoid
Overview of the webinar
Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. A similarity to critical proteins in human physiology or possible interference with endogenous pathways increases the risk of immunogenic responses. Changes in protein modification or formulation may not diminish the risk sufficiently. During the drug development process, regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding agency expectations should allow a reasoned and risk-based approach to assessing potential problems with immunogenicity.
In a risk-based approach, the structure of the biologic compared with any endogenous proteins in the same family and the function within physiological pathways are critical analyses necessary to determine the potential level of risk. Understanding the risk, even if assumed to be low, does not preclude developing selective and specific validated methods that provide data on the presence of anti-drug antibodies. These methods must detect low levels of antibodies in different matrices as well as in the presence of the drug load. The methods can have false positives but the expectation is a low tolerance for false negative samples. Testing for immunogenicity is a matter of safety and must be rigorously assessed. A multi-tiered approach is typical. Successful implementation of a risk-based approach to immunogenicity to biological drugs promotes safety by having validated methods in place to quickly identify anti-drug immune responses in the patient population.
Who should attend?
- Quality Assurance Specialists and Managers
- Development and Validation Scientists
- Regulatory Affairs
- Consultants
Why should you attend?
Validation of the methods to test for immunogenicity is on the critical path for successful drug development for biologics. Insufficient preparation or minimal assessment of the required timeline can lead to failed attempts at validating methods to test for immunogenicity. Careful consideration of critical factors during method development that influences either, the initial screening method or the method that assesses neutralizing antibodies increases the likelihood of achieving a successful validation.
This webinar provides valuable insight into a risk-based approach to immunogenicity to biologics. Included are specific topics on an early and final development of methods needed to assess immunogenic responses to biotherapeutics. This webinar discusses those important factors that influence assay design and development that have an impact on method validation. Components of the validation, data analysis, and the validation report are additional topics addressed in this webinar.
Faculty - Dr.Gwen Wise-Blackman
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.