AIT Bioscience Gains FDA Regulatory Insights at AAPS Guidance Forum - AIT BioscienceAIT Bioscience

AIT Bioscience Gains FDA Regulatory Insights at AAPS Guidance Forum

Swarna Ramaswamy Attends the 2018 AAPS


Guidance Forum


AAPS Guidance Forum


Recently, AIT Bioscience’s Senior Scientist, Swarna Ramaswamy, attended the 2018 American Association of Pharmaceutical Scientists (AAPS) Guidance Forum in Silver Spring, Maryland. Swarna was among experts in the life sciences industry, FDA regulation and academia who attended the AAPS forum to discuss the 2016 FDA draft guidance for immunogenicity testing of therapeutic protein products.


The conversation was focused on FDA interpretations of the draft guidance document, best practices, as well as alternate approaches to deal with unique scenarios not fully covered by the FDA draft guidance. AIT Bioscience attended this forum to gain valuable insights into the advancements and issues surrounding robust immunogenicity methods. There are nuances associated with conducting ADA assays that are not directly addressed by the draft guidance, which require our scientists to treat every molecule and assay as an individual entity, while aligning with FDA recommendations. Conversation with the FDA and other industry experts keeps us aligned with industry best practices, making us more equipped to accommodate sponsors that have unique requirements. In turn, this allows us to truly meet our sponsors wherever they are in the drug development process.


Given the unique nature of anti-drug antibody assays, this forum provided great value to our lab and our sponsors.  It allowed us to expand our understanding of the therapeutic areas that are proving to be the future of biotherapeutics. The more insights we glean from events like this one, where we were able to learn alongside industry leaders and FDA regulators, the better we can service our sponsors. Learn more about our Anti-Drug Antibody assay capabilities or contact us for more information about the insights we gained from this forum.

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