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By Louis Garguilo, Chief Editor, Outsourced Pharma | Ben Stevens of GSK documents his career, and highlights a stage in outsourcing we often overlook – key interactions between med-chem scientists and research biologists, and contract development and manufacturing providers (CDMOs). |
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Characterizing Injection Factors And Their Impact On System Function | Poster | By Wendy D. Woodley, BS, Didier R. Morel, Ph.D., et al., BD Medical - Pharmaceutical Systems | The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options. |
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A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs | Article | By Nicholas Field, Stuart Jamieson, Pedro Marques, and Eddy Berthier, Lonza | Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat. |
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Building A Fully Single-Use Process: Protein A Membrane Devices | Case Study | By Shunsuke Shiina, Ph.D., Chase Snyder, Neha Saxena, Ph.D., and Rodrigo Gonzalez, Ph.D, AGC Biologics | Learn how a disposable upstream and downstream platform process in antibody production can increase timelines, enhance scalability, and reduce risk in biologics manufacturing. |
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How mRNA Technology Engineers Next-Generation Antibodies | Article | By Christian Cobaugh, Vernal Biosciences | Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery. |
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Putting The “Process” Into Process Characterization | Article | By Daniel Sayut, Lisa Rives, and Evan Pasenello, AbbVie | Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Examine a platform approach to Process Characterization that has been proven effective in supporting the approval of several products. |
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Bulk Filling Of Drug Substance | Accurate Aliquoting | Application Note | By Natasha Kelly, Cytiva | Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to achieve accurate filling. This method increases process risk through errors that can compromise accuracy. |
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| Webinar: CDMO Perspectives in Biotech Drug Development | Join us on June 24th and learn characteristics of CDMOs that work best with early-stage, small biotech projects and a framework to manage them for success! Content in this webinar will explore this realm from the perspectives of the various stakeholders, history lessons, and future considerations. Click here to learn more. |
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Bioanalysis Solutions | SGS | Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence. |
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Potency Assay Development - Creating Potential Together | Labcorp Biopharmaceutical CMC Services | It is necessary to achieve a well-designed and developed potency assay as it is the only analytical technique that can demonstrate the biological mechanism of action and the link to clinical efficacy. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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