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Technology Transfer: A Seamlessly Integrated Approach | e-book | By Martin Gonzalez, Pfizer CentreOne | From the digital infrastructure needed to enable a collaborative approach to the quality systems and analytical methods, effective tech transfer relies on consideration of a variety of factors. |
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By Louis Garguilo, chief editor, Outsourced Pharma | When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered. | |
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Key Elements Of Effective Tech Transfer Management | By Outsourced Pharma Live | This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” focuses on the key elements of a successful tech transfer for small molecule processes, emphasizing realistic expectations on duration, leveraging CDMO chemistry expertise to refine rather than simply copy the process, and treating the CDMO as an extension of the sponsor’s own team focused on long-term product quality. Featuring panelist Natalie Farris, Executive CMC Consultant at Naltou Pharma CMC Consulting, LLC. |
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INDUSTRY INSIGHTS CONTINUED |
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Solid Form Services | Lonza | We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program. |
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Small Molecule: Development And Manufacturing | Curia | With over three decades of experience, Curia Small Molecule specializes in process chemistry, process safety, scale-up, and cGMP API manufacturing for preclinical, clinical, and commercial supply. |
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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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