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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 | “I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.” | |
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| How To Choose The Right CDMO Partner For Fill & Finish | Article | medac CDMO | CDMO selection requires evaluating experience, quality standards, and flexibility. Assess technical transfer skills, supply chain security, and collaborative approach for a reliable, long-term project fit. |
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| The Advantages Of Off-The-Shelf GMP iPSCs With A DMF | Webinar | Applied StemCell | Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic. |
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| Simulated Control Strategy For Product Diversion Management | Poster | By Rui Wheaton, Ahsan Munir, Thomas Erdenberger, et al., Resilience, LLC. | Consider this manufacturing platform integrating perfusion bioreactors, continuous product capture, low pH viral inactivation, polishing, viral filtration, and formulation steps. |
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| How Does A CMO Define Legacies? | Infographic | Pfizer CentreOne | Partner with a CMO that combines expertise, innovation, and trusted global capabilities to bring life-changing therapies to patients faster and more reliably. |
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