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By GlobalData | Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections. | |
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| Why Developability Assessments Matter | Article | By Dr. Rob Holgate and Dr. Gary Watts, Abzena | Developability assessments flag early risks in stability, manufacturability, and biophysics, helping teams focus on candidates most likely to succeed clinically and commercially. |
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| Using Tech Transfer To Accelerate NDA Approval | Case Study | Syngene International Ltd. | A biotech company accelerated NDA approval for a novel anti‑infective by executing a highly disciplined, first‑time‑right technology transfer and registration batch manufacturing strategy. |
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| Building A Path To A Successful AAV Product | Webinar | Coriolis Pharma | See state‑of‑the‑art analytical methods for AAV characterization, key quality attributes to monitor, and approaches for measuring infectivity and full‑to‑empty capsid ratios. |
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| Accelerating Gene Therapy Development For NEDAMSS | Article | Andelyn Biosciences | Find out how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis. |
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