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| Why Sterile Manufacturing Matters For ADC And CDMO Success | Sterile manufacturing is increasingly a strategic differentiator in drug development, particularly as antibody-drug conjugates (ADCs) add complexity to formulation, fill/finish, and lyophilization. This collection explores critical decisions around in-house manufacturing, outsourcing, and CDMO selection, alongside ADC-specific lyophilization challenges. Technical perspectives on process development, cycle optimization, controlled ice nucleation, drying, and automated visual inspection offer practical guidance for improving efficiency, consistency, and product integrity while reducing risk and accelerating progress toward commercialization. |
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| Sequence To Scale In 7 Months | Video | Future Fields | Learn how an insect-based expression platform overcomes protein manufacturing challenges, enabling rapid scale-up of complex recombinant proteins from sequence to commercial production. |
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| Protecting Product Integrity Through Cold Chain | Article | Jubilant HollisterStier | Reliable temperature‑controlled storage, monitoring, and safeguards keep sensitive materials stable from fill to patient, protecting quality, preventing degradation, and ensuring safety. |
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By Louis Garguilo, chief editor, Outsourced Pharma | The FDA calls on your CDMO; its 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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CDMO Selection Beyond Capabilities And Price | By Matthias Gerlach, Ph.D. | Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story. |
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INDUSTRY INSIGHTS CONTINUED |
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| Accelerate Your HEK Cell Line Development | Webinar | Catalent | Discover how an advanced cell line development platform supports HEK cells alongside CHO, enabling rapid, scalable production of complex biologics while saving up to 12 weeks on development timelines. |
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| How To Build A Defensible CCIT Method Selection Strategy | Article | By Christian Collazo-Sarra, Pace® Life Sciences | Selecting the right CCIT strategy starts with defining leakage risks and defect limits. Matching test methods to package design supports compliance, lifecycle needs, and patient safety. |
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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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