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| When navigating the clinical trials process to bring a molecule to market, meeting the regulatory standards required for the approval of new mRNA-based drug products is critical. A crucial aspect is developing extensive chemistry, manufacturing, and controls (CMC) documentation, outlining the quality of drug substance and product. This article explores the regulatory requirements for mRNA drug substance and product, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance. Download now! |
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By GlobalData | Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections. |
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| A CDMO's Checklist For Prospective Clients: Part 3 | Article | Theragent | In the last entry of our client checklist series, we delve into crucial aspects such as project management, decision-making, MSA negotiations, and building trust in CDMO-client partnerships. |
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| Demystifying CGT Studies In Australia And The Broader APAC Region | Article | By Dr. Jennifer Hollands, Cell Therapies, and Dr. Jorgen Mould, Avance Clinical | Though conducting your clinical trial in Australia may initially seem daunting, the benefits are ample. Australia is home to qualified CRO partners that will guide your CGT to regulatory success. |
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| Adapting A rcAAV Assay For Commercial Manufacturing | White Paper | By Oxana M. Tsygankova, Ph.D., Leann Walsh, Lana Sweet, Dana Cipriano, and Brian Tomkowicz, Ph.D., SK pharmteco | Better understand the intricacies of AAV triple transfection and how advances in vector production and cell line optimization are enhancing gene therapy. |
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| Lentiviral Vector Platform: Right The First Time | Article | By Mercedes Segura, Dawn Maier, and Bojiao Yin, ElevateBio | Leveraging the right LVV manufacturing platform can accelerate timelines, better manage costs, and transform product development and potential for clinical success so that therapies reach patients in need. |
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| Despite significant advances, challenges remain in optimizing AAV-based treatments for broader clinical application. Join Cell & Gene Live on December 10th for a discussion on the latest developments in AAV vector design, manufacturing processes, and clinical strategies as well as key issues such as immunogenicity and regulatory considerations that are shaping the future of AAV gene therapies. Registration is free thanks to the support of Roche CustomBiotech. |
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