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Moving into GMP manufacturing can bring costly challenges—from sourcing and validating materials to regulatory compliance, risk assessment, and facility fit. Join Bioprocess Online’s Tyler Menichiello and industry experts Wei Lu, Ph.D., Tiffany Rau, Ph.D., and Mary Rodley 9/18/26 at 11 AM ET for an interactive panel on phase-appropriate CMC decisions and material selection. Discover key considerations for implementing GMP-grade materials and equipment while preparing your process for successful clinical manufacturing. Register today!
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By GlobalData
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Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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Enhancing Safety In Drug Substance Synthesis
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Article | Ardena
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Discover how safety‑by‑design principles in chemical synthesis help control exothermic reactions, reduce scale‑up risk, and enable safer, more reliable manufacturing of complex drug substances.
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Expanding The Capabilities Of Targeted Integration
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White Paper | Applied StemCell
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See the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.
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Managing Supply For Complex Biotherapeutics
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Article | By Iwan Bertholjotti, Lonza
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Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.
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Digging Into Manufacturing Priorities For Viral Vectors
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Article | Novartis Contract Manufacturing
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Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.
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Strategic Approaches On The Path To GMP Manufacture
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Q&A | Avid Bioservices
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Tech transfer is a critical opportunity to establish a strategy for process performance qualification, mitigate late-stage obstacles, and streamline the pathway to clinical and commercial production.
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