Good Manufacturing Practices (GMP) require that manufacturers demonstrate that they have cleared drug substances of residual HCPs to the lowest level possible prior to releasing their drug products. The methodologies for meeting this challenge are changing rapidly as new instrumentation and techniques are becoming available to laboratories. The following paper outlines the latest developments, focusing on emerging best practices.
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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.
Frontage is a global CRO advancing drug discovery and development with a comprehensive portfolio of genomics services. We deliver accurate and in-depth analyses to move compounds through early discovery and preclinical studies and for translational and clinical programs.
Frontage’s Biologics, Gene, and Cell Therapy Operations (BGC) Unit supports the development of biologics products. We develop complex analytical techniques to support drug substances, drug products, comparability studies, and stability programs.