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| Built‑In Quality For Audit‑Ready Manufacturing | Article | By Melodie Bryce, Kincell Bio | Pre‑approval inspection readiness requires embedding quality, traceability, contamination control, and robust analytical and documentation practices into everyday cell therapy manufacturing. |
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| Improving LVV And AAV Yield Through Cargo Gene Silencing | Poster | By Qian Liu, Sherin Parokkaran Johny, Matthew Tridgett, et al., Minaris | Silencing cargo gene expression during LVV and AAV production improves cell health, reduces impurities, and significantly increases vector yield for cytotoxic and difficult‑to‑manufacture transgenes. |
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| Accelerated Yield Optimization Of Affinity Capture | Poster | SK pharmteco | High‑throughput affinity screening shows how buffer and pH optimization can boost AAV5 recovery, enabling faster, more reliable downstream process development for challenging serotypes. |
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By Louis Garguilo, chief editor, Outsourced Pharma | AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant. | |
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FDA's Guidance On Cell And Gene CMC Codifies Flexibility | A conversation with Arnold & Porter’s Abeba Habtemariam and Jonathan Trinh and Life Science Connect's Jon O'Connell | The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis. |
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In Palm Beach The Focus Is On Biotech (Not President Trump) | By Louis Garguilo, chief editor, Outsourced Pharma | “When I came to Florida,” James Sapirstein says, “I was leaving New Jersey because of tax reasons.” That was 2018. Timing is everything, they say. Sapirstein’s relocation placed him ahead of a broadening and intensifying migration trend – including he believes, a new biotechnology settlement. This is not news to readers – Miami alone seems perennially in the headlines. “Economics drives investors,” Sapirstein says, and Sapirstein is committed spearheading “a new kind of biotech cluster." |
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INDUSTRY INSIGHTS CONTINUED |
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| Enhancing AAV Production Performance And Economics | Application Note | Touchlight | Enzymatically produced dbDNA offers safer, faster, and more scalable AAV manufacturing by reducing costs, improving full capsid yields, and enabling high‑fidelity, bacteria‑free DNA production. |
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| Choosing The Best mRNA Manufacturing Strategy | Article | Cytiva | Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth. |
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| Reducing Lead Time, Delivering >99.5% OTIF | Case Study | Thermo Fisher Scientific Bioproduction | Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth. |
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