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| AI Innovation in Drug Development | AI is shifting from experimentation to execution in drug development. This OPCU special edition explores where AI delivers value today—across discovery, CMC, and quality—and how CDMOs and sponsors can collaborate to reduce risk, improve quality, and accelerate timelines, with practical guidance on readiness, regulatory considerations, and sponsor expectations. |
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Silencing Lentiviral Cargo For Cell Therapy | Poster | By Sherin Parokkaran Johny, Maria Ababi, Harry Jenkins, et al., Minaris Advanced Therapies | Silencing lentiviral cargo genes boosts vector yield, enhances cell viability, and reduces impurities, enabling scalable, cost-effective manufacturing for complex gene therapies. |
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Integrating Analytical Method Development And Quality Control | Article | By Michael Sousa, Eli Kraus, and Manish Tandon, Landmark Bio | As cell and gene therapies continue to advance, a well-integrated analytical framework will be critical for accelerating development timelines and optimizing regulatory submissions. |
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By Louis Garguilo, chief editor, Outsourced Pharma | It is a remarkable twist of industry manipulations, government suasion, and economics. J&J cut a Most Favored Nation deal with the Trump administration that includes lowering prices – via TrumpRx.com – building more in the U.S., and (here’s the twist) investing in the U.S.-based facilities of a Japanese-owned CDMO. Got all that? Chief Editor Louis Garguilo offers analysis. | |
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In Vivo's Biggest Threat — Comparison To Old Models | By Arnaud Deladeriere, Ph.D., Cell & Gene Consulting Inc. | In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes. |
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INDUSTRY INSIGHTS CONTINUED |
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The Continuation Of A Journey | Article | Andelyn Biosciences | See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis. |
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Solving The Sequencing Puzzle: Speed, Cost, And Quality | Article | By Adriana Geldart, Ph.D., ElevateBio | Next-generation sequencing (NGS) accelerates therapy development by enabling rapid, cost-effective DNA/RNA analysis crucial for cell and gene therapies, process optimization, and impurity detection. |
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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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The Future Of Lentiviral Vector Innovation And Access | Vector BioMed | Built on deep expertise in viral vector design and manufacturing, explore a comprehensive set of tools to rapidly deliver advanced therapies and support the development of next-generation treatments. |
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iPSC Generation Services | Applied StemCell | iPSC generation is a complex process of reprogramming adult somatic cells into a pluripotent, embryonic stem cell-like stage. |
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CHO Edge System | Asimov | Achieve high monoclonal antibody and complex bispecific titers routinely with an IND-approved cell line development platform that integrates genetic tools and data-driven models. |
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Two-Side Labeler For Challenging Product Shapes | HERMA | This two-sided labeling machine brings precision and versatility to your production line. This high-speed workhorse labels up to 200 products per minute, even those with challenging shapes. |
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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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