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

• Main Authors: Aming Zhang (Author), Zhengwei Chen (Author), Meinuo Li (Author), Haibo Qiu (Author), Shawn Lawrence (Author), Hanne Bak (Author), Ning Li (Author)
• Format: Book
• Published: Taylor & Francis Group, 2020-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 syste...