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By Louis Garguilo, Chief Editor, Outsourced Pharma | The CEO of the Biotechnology Innovation Organization (BIO) spearheading expulsion of WuXi Apptec relied on WuXi Biologics as CEO of the biotech he founded. More on this and some breaking news on the U.S. government's accusations regarding WuXi, from Chief Editor Louis Garguilo. |
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CDMO Carve Out Specialists | By Louis Garguilo, Chief Editor, Outsourced Pharma | How do investors influence our outsourcing ecosystem? Chief Editor Louis Garguilo asked one. But not just any investor. He spoke to a CDMO “carve out” specialist, who provides a window into how investors, sponsors, and CDMOs come together, and come apart. |
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FDA’s CBER Issues Final Guidance For CAR T Cell Products | By Annie Lamontagne and Wendy Liang, Dark Horse Consulting Group | The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance. |
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Transform Your Cell Therapy CDMO From Service Provider To Partner | Article | By Dr. David Smith and Dr. Chathuranga De Silva, BioCentriq | Review what a cell therapy CDMO will do to demonstrate that not only are they strong and capable but also a true partner in what will be the most important years of your company's journey to success. |
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The Role Of Early Characterization Studies In Assessing CGT Potency | Article | By Rubina Pal and Eva Morschl, Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays. |
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Upstream Optimization Paved A Straightforward Path For Full Capsids In AAV6 | Poster | By James Fasano, Azam Hassaninasab, Daniel Kennedy, Theresa Dao, Jay Cai, Omar Matalka, Christine Beaudry, Miranda Williams, Lorenz Ponce, et al., ElevateBio | Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product. |
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The Power Of Small: Nanoplasmid Vector Platform | Aldevron | With gene therapy advancing at a record pace, Aldevron recognizes the enormous promise your work can bring to therapeutics. We are proud to deliver a superior, modern plasmid technology to your therapeutic endeavors. |
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Scalable, cGMP-Ready AAV And LV Platform Processes | IDT Biologika | Our expertise and capabilities allowed us to produce our own HEK293 production cell lines utilizing a wide variety of upstream platforms including iCellis, cell stacks, Univercells, and stirred-tank reactors. |
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iPSC CDMO Services | OBiO Tech | Explore solutions for reprogramming, gene editing, cell banking, and differentiation. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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