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| Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva. |
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By Louis Garguilo, chief editor, Outsourced Pharma | For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO. | |
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| The Gateway Delivery To The Brain | Article | By Justin Lygrisse, Kindeva | Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress. |
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| Shaping The Future Of Biologics Manufacturing | Q&A | Avid Bioservices | CEO Kenneth Bilenberg discusses building a CDMO's success on trust, reliability, and true partnership. The path focuses on agility to support biologics growth and the reshoring of U.S. manufacturing. |
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| A Strategic Enabler For Scaling Gene Therapies | Article | AGC Biologics | Platform-based manufacturing uses standardized, pre-qualified workflows and analytics that reduce variability, simplify regulatory submissions, and accelerate the path to commercial success. |
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