The process development of oral solid dosage forms occurs across multiple phases. The final scaled up process is not typically finalized until shortly before filing for commercial approval. Continuous manufacturing is well suited for phase III development and clinical manufacturing and enables late-phase development by ensuring a greater quality assurance and reducing API usage. Additionally, continuous manufacturing doesn’t require scale up and expedites readiness from phase III to commercial.
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Doug is the Senior Manager for Continuous Manufacturing Business Development at Thermo Fisher Scientific. He is a subject matter expert in continuous manufacturing. Prior to joining Thermo Fisher Scientific, Doug spent 9 years leading the development of continuous manufacturing technology at Rutgers University and the NSF Engineering Research Center, C-SOPS.
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