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.
Register to gain access to gated resources.
Thank you for registering!
You may now view the resource below.
The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing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 paper, we explain how bioequivalence can be achieved for generics in semi-solid dosage forms, including the role of in vitro release testing (IVRT) and in vitro permeation testing (IVPT).
In this study, we validate the ELISA method and deem it to be suitable to quantify GDF8/Myostatin in human serum.
Fascin is an actin-bundling protein that has been linked to tumor cell migration, invasion, metastasis, disease progression and mortality, thus serving as a novel cancer biomarker. In this paper, we develop and validate an LC-MS/MS method for the quantification of fascin proteins in human serum.