A general evidence-based sequence variant control limit for recombinant therapeutic protein development

Abstract excerpt

Sequence variants (SVs) resulting from unintended amino acid substitutions in recombinant therapeutic proteins have increasingly gained attention from both regulatory agencies and the biopharmaceutical industry given their potential impact on efficacy and safety. With well-optimized production systems, such sequence variants usually exist at very low levels in the final protein products due to the high fidelity...

Topics

Share this publication in a Topic to start or enrich a Post.

• Share to Monoclonal and Polyclonal Antibodies Research
• Share to Protein purification and stability
• Share to Viral Infectious Diseases and Gene Expression in Insects