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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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| Digging Into Manufacturing Priorities For Viral Vectors | Article | Novartis Contract Manufacturing | 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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| Efficient Plasmid Linearization: Type I & II Enzymes | Poster | By Charlie Fan; Delicia Henriques, Justin Chen, et al., ProBio | Advanced plasmid linearization improves transfection efficiency and gene expression, delivering high-purity DNA with rapid turnaround, low endotoxin, and scalable processes. |
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By Louis Garguilo, chief editor, Outsourced Pharma | Subpar customer service at CDMOs is no longer something sponsors tolerate; there’s enough competition where they can move on. The other side of the coin is how difficult sponsors sink to the bottom of CDMO priorities; providers also have options. Here's an analysis less about technical components of outsourcing, and more on mutual satisfactions from working together to fulfill contractual arrangements and missions. | |
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By Louis Garguilo, chief editor, Outsourced Pharma | "I should have known," writes Chief Editor Louis Garguilo, "It takes an accomplished biologist to most effectively describe the significance of artificial intelligence in our outsourcing industry, and put it to practical use." That professional is Damiano Dragone, Founder & Principal Advisor, Dragone Consulting, who built a career across pharmaceutical quality and data-driven quality environments within the biopharmaceutical industry, and was an early proponent of the promise of AI in quality, development and manufacturing, and the supply chain. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Accelerating Gene Therapy Tech Transfer With Confidence | White Paper | By Ane Quesada and Joschka Buyel, Viralgen | Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding. |
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| A Platform For Advanced AAV Analytics | Article | Andelyn Biosciences | Advanced AAV analytics use high‑resolution multiplex platforms to assess genome integrity and capsid traits, improving accuracy, speeding development, and supporting regulatory quality control. |
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| What's The Greatest Risk For CDMOs Ahead? | Q&A | Vector BioMed | Economic volatility, regulatory uncertainty, and capacity constraints pose major risks to CDMOs, threatening growth, profitability, and long-term sustainability in an increasingly competitive global market. |
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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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