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By Natalie Farris, Naltou Pharma CMC Consulting LLC | When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving. | |
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By Tamika Drummond, Ph.D., external MSAT manager, AbCellera | This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership. | |
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By Ashwin Sancheti, Ph.D., bioprocess engineer | As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications. | |
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By Md Saddam Nawaz, ACI HealthCare Ltd. | In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades. | |
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| Process Analytical Technology In The ADC Bioconjugation Process | White Paper | By Haowei Song, Yiyi Li, Kim Nguyen, Jake Spikes, Mary Ramisetty, Gang Yao, and Lisa MacDermott, MilliporeSigma | Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment. Explore more about PAT's role in ADC production. |
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