Register now for our webinars covering innovations in bioanalytical or immunogenicity technologies and the latest regulatory expectations from the FDA for immunogenicity testingRegulatory requirements, product complexity, and diverse biological matrices present formidable bioanalytical or immunogenicity challenges. Register now for our complimentary webinar series to learn more about the FDA expectations for immunogenicity testing, alternative technologies for measuring immunogenicity and also an introduction to a range of innovative and non-conventional bioanalytical technologies. The last webinar in the series will look at how to determine the best way to develop and validate pharmacokinetic (PK), immunogenicity (ADA), and neutralizing antibody (NAb) assays for a biosimilar. Click the registration links below to reserve your place or to register your interest in receiving the recorded webinar to listen to at your leisure.
Be Prepared and Know the FDA’s Expectations Regarding Immunogenicity Testing – Lessons Learned
Wed 23 May 2018 at 16:00 BST / 08:00 PDT
The FDA released an update to the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins in April 2016. This webinar will outline how the April 2016 draft document is being used in FDA inspections and the FDA expectations for immunogenicity testing. Specific testing parameters and acceptance criteria will be discussed in depth in addition to 483 issued in the field of immunogenicity and what they mean.
What will you learn?
How to determine the best way to develop and validate pharmacokinetic (PK), immunogenicity (ADA), and neutralizing antibody (NAb) assays for a biosimilar
Date: Wed 11 July 2018 at 16:00 BST / 08:00 PDT
The US FDA defines a biosimilar as a biological “product highly similar to the reference product without clinically meaningful differences in safety, purity and potency.” In other words, a biosimilar is a copy of an approved version of a biologic drug. There is an increased interest in developing biosimilars for the US and Global markets since many of the first generation biologics’ patents are expiring.
Views about how to approach the development of PK, ADA and NAb assays for biosimilars vary, but what’s the best way? This webinar will explore the different options and focus on the clinical bioanalytical scientific and regulatory aspects of biosimilar drug development. The regulatory aspects, including case studies, will also be discussed.
You will learn:
Need help or have a question?