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| The Crucial Role Of Apheresis In Cellular Therapies | Webinar | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Focusing on quality, the presenters will discuss the importance of adhering to collection protocols and the real-world effects on treatment outcomes. |
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By Louis Garguilo, chief editor, Outsourced Pharma | GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs. He will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.” | |
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Trends In FDA FY 2025 Warning Letters | By Erin Hartmann and Liz Oestreich, ELIQUENT Life Sciences | The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends. |
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INDUSTRY INSIGHTS CONTINUED |
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| Efficient Plasmid Linearization: Type I & II Enzymes | Poster | By Charlie Fan, Delicia Henriques, Ph.D., 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 for CGT applications. |
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| A Comprehensive Solution For Adventitious Agent Testing | White Paper | MilliporeSigma | Modern sequencing methods offer detection of adventitious and species‑specific viruses. Assimilate how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization. |
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| Gene Therapy Delivered In 14 Months | Webinar | Andelyn Biosciences | Hear how one family, driven by urgency, partnered with AAV experts to develop a treatment for their daughter’s ultra-rare neurodegenerative disorder, NEDAMSS, in just 14 months. |
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| Choosing The Best mRNA Manufacturing Strategy | Article | Cytiva | Choosing the right mRNA manufacturing model can define your success. Uncover how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth. |
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Cell Therapy Lot Release Package | Minaris | Comprehensive cGMP-compliant cell therapy lot release testing includes identity, potency, safety, and characterization assays, ensuring regulatory compliance and timely product release. |
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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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