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| In biologic-based analytical CMC drug development, one of the most challenging obstacles in entering Phase II clinical trials is the cell-based potency assay. Common problems with CMC regulatory submissions include inadequate methods, lack of appropriate potency assays, or method description issues. The complexity of developing and validating a relative potency assay is often underestimated, given the need to balance MOA demonstration with minimizing variability. Learn more about how to develop a CMC Relative Potency Assay. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | Like others, Saudi Arabia has been dependent on vaccines supply from abroad. That’s about to change. According to the CEO of Emergex, the Saudis intend to produce a new generation of vaccines — predominantly based on "T cell priming, the next step beyond mRNA vaccines.” |
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Developability Assessment Of Three Therapeutic Antibodies | Poster | By Tao Bi, Yesenia Aguilar, Paul Phelan, Laura McDevitt, Henry Yong, David Gae, Anjali Patel, Wen-Rong Jiang, Tao He, and Zhiping Yao, JOINN Biologics | Review studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability. |
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Optimizing And De-Risking With Real-Time, Viable Environmental Monitoring | Article | By Nadiyra Walker, Henrik Herrmann, and Anders Magnusson, FUJIFILM Diosynth Biotechnologies | Real-time, viable environmental monitoring is proving to optimize manufacturing timelines via immediate results, alleviate the risks associated with traditional environmental monitoring methods, and satisfy Annex 1 regulations. |
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Lift Your CLC Expectations To A New Level | Poster | By James Taylor, Lai-Kay Cheung, Carol Bentley, Arina Alfred, Sarah Turner, and Ramón Gómex de la Cuesta, Lonza | Using transposon technology, a substantial improvement can be achieved by pseudo-targeting DNA cargos to integration sites where recombinant protein expression is likely higher in various cell types. |
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The Growth Of Sterile Injectables | White Paper | PCI Pharma Services | Learn why partnering with a manufacturer capable of delivering flexible aseptic fill/finish solutions for any size production run is essential for delivering products to patients safely and efficiently. |
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Primary Drug Containers | SMC Ltd. | Oval’s proprietary primary drug containers offer a wide range of benefits over traditional glass based systems. Our COC primary drug container is used as the basis for our platforms ArQ, ArQ - Bios and ArQ - Vita. |
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Analytical Development | AGC Biologics | Robust and validated release methods, including bioassays, are developed to ensure the identity, safety, purity and potency of your product. Our in-house bioassay group specializes in development and validation of cell-based assays. |
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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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