Dr. Terri Gaskell, CTO of Rinri Therapeutics, shares her insights on developing and manufacturing a PSC therapeutic at IMAPAC Biomanufacturing 5.0 conference today in London. Her advice? Begin with the end in mind. Don't just focus on what is acceptable in a First-In-Human (FIH) trial, but consider what will likely change to generate a commercial product.
Dr. Gaskell emphasizes the importance of collecting everything while developing your manufacturing process. This will facilitate retrospective analysis and help you identify areas for improvement. Additionally, it's crucial to know the sensitivity, robustness, and limitations of your tools. Rely on them only as much as justified. Bank sufficient material to validate your assays if justified in risk assessment.
Remember, developing a successful commercial product requires thoughtful planning and attention to detail. Thank you, Terri, for sharing your valuable insights.
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