In this podcast, we discuss tips for developing an ELISA for residual host cell proteins (or HCPs) for biopharmaceutical products using commercial kits with our special guest: Dr. Jeng-Dar Yang, Vice President of Biologics Development and Manufacturing Services at Frontage Laboratories, Inc.
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The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing as a surrogate for in vivo testing.
In this webinar, Dr. Santosh Shah discusses the general industry standards for utilizing critical reagents in bioanalytical labs, importance of bridging various lots of critical reagents and maintaining stocks, and reviews proper storage, management, and documentation of critical reagents.
In this poster, we validate ultra-high sensitive SIMOA assays for the successful quantitation of neurofilament light chain (NF-L) and glial fibrillary acidic protein (GFAP).