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| Why Manufacturing Drives FDA CRLs In Cell Therapy | Article | By Cindy Riggins, ElevateBio | Manufacturing and quality gaps drive most FDA Complete Response Letters in cell therapy, often stemming from early‑stage decisions and unresolved CMC issues that become late‑stage approval risks. |
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By Louis Garguilo, chief editor, Outsourced Pharma | Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III. | |
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A Biotech Business Model That's Investor-Friendly | By Louis Garguilo, chief editor, Outsourced Pharma | For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO. |
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April 2026 — CDMO Opportunities And Threats Report | By GlobalData | This 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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INDUSTRY INSIGHTS CONTINUED |
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| Vendor To Visionary: Transforming AAV Manufacturing | Article | By Artur Padzik, 3PBIOVIAN | Early, collaborative CDMO partnerships optimize complex AAV development, enhancing manufacturability and reducing risks to shorten timelines more effectively than traditional models. |
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| Optimizing AAV8 Capsid Purification With Oversized GOI | Poster | By Yeonji Kim, Chris Brown, Jing Zhu, et al., Recipharm Advanced Bio | Enhance AAV gene therapy quality and regulatory compliance with our advanced AEX-based purification platform, achieving >90% full capsid purity — even for oversized AAV8 vectors. |
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| Strategies For Engineering Mammalian Cells | Video | Applied StemCell | Using cells with a pre-engineered landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort. |
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OUTSOURCED PHARMA CAPABILITIES UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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| Connect With Outsourced Pharma: |
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