Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. System suitability and sample acceptance criteria are similar in some instances. However, differences exist when considering methodology specific for large molecule therapeutics. Although some variability is expected, when development is performed and development data assessed with enough detail to examine suitability for validation, both the validation and subsequent sample analysis may occur with limited failures. This webinar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and ELISA methods. In addition, this webinar addresses using Design of Experiments (DOE) to collect early data to design within the limits of the planned method. DOE is also useful to support moving from development to validation. This webinar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the webinar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Individuals who attend this webinar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods for large molecule therapeutics.

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products. Clinical laboratories also must follow stricter procedures for accreditation and validation of test methods per current ISO requirements. Selecting the right method to validate or if a method is ready for validation starts with the research lab or method development lab and data that support the decision to proceed. Understanding the requirements for a method to be considered validated helps with the decision-making process. Also, having a thorough understanding of regulatory agency expectations can prevent unnecessary problems with the acceptance of analytical methods. This webinar will describe essential practices for bringing analytical methods from development through validation in laboratories supporting biologic products as well as clinical laboratories.