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| Webinar: From iPSC Starting Material To Scalable GMP Manufacturing | Developing scalable, high-quality iPSC sources can be complex as cell therapy programs move toward clinical manufacturing. This webinar explores an integrated approach combining GMP iPSC lines, working cell banks, GMP-compatible media, and standardized expansion protocols. Learn how this coordinated system can simplify process development, support reproducible high-volume iPSC feed streams, scale to billions of cells, and enable downstream differentiation. Click here to learn more. |
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| Ultra Low Temperature Packaging Solutions | Case Study | Almac Pharma Services | How do you protect advanced therapies in transit? Discover how a tailored ultra-low temperature supply chain helped maintain quality, compliance, and uninterrupted delivery. |
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| What Sponsors Get Wrong When Selecting A CRO | Article | Dash Bio | Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | The FDA calls on your CDMO; inspectors are fortified by data in AI models, and appear practically clairvoyant. “It won’t be like the ‘old days,’” says David Grote of GrayMatters Partners, an organization that advises on quality systems and inspection readiness. The agency earlier rolled out Elsa, an AI-enable data architecture. Now its added an impressive HALO - Harmonized AI & Lifecycle Operations for Data. | |
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What Conference Audiences Actually Want To Hear | By Louis Garguilo, Chief Editor, Outsourced Pharma | In-person events should be a tool for separating the noise from authentic signals. Through “content design,” the best conferences provide you direct market insights via information aggregation, discussion, and business meetings. The founders of CDMO Live conferences speak with Chief Editor Louis Garguilo on “curating" events for optimal development and manufacturing outsourcing outcomes. In short: No wasted words; no wasted time. |
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The Hidden Price Of Analytical Validation Compliance | By Bilel Khedir, Galien Pharmaceuticals | By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency. |
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INDUSTRY INSIGHTS CONTINUED |
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| Translating Massive Data Into Therapeutic Momentum | Article | By Matt Clark, X-Chem | New advances in chemomics, proteome mapping, and modern synthetic methods are redefining how quickly and precisely discovery teams can move from raw data to meaningful clinical momentum. |
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| Unlocking Durable Allogeneic Cell Therapy | White Paper | Applied StemCell | Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases. |
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| The New Rules Of Developing Novel AAV Capsids | Q&A | Viralgen | The shift toward engineered AAV capsids is expanding therapeutic possibilities while making manufacturability, analytical readiness, immunogenicity, and regulatory strategy integral to selection. |
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| Evaluation Of Synthetic DNA As An Alternative To Plasmid DNA | Article | By Celine Winkler, Milena Pavlickova, and Blanka Awtani, 4basebio | Synthetic DNA replaces plasmids for AAV production, cutting contaminants and variability and improving reproducibility and scalability from research to manufacturing. |
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| Enabling Success in Cell & Gene Therapy — October 29 at 11:00 a.m. ET | Explore the technologies, capabilities, and scale-up strategies advancing cell and gene therapy manufacturing. Leading CGT CDMOs will share insights on process development, technology transfer, clinical supply, and commercial readiness, helping sponsors evaluate potential partners and navigate the unique challenges of advanced therapy manufacturing. Learn more. |
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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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