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| Viral Clearance - Something Went Wrong, What Do I Do Now? | Even the strongest viral clearance study design may encounter issues with sufficient clearance to reach target safety expectations. Working with experts can help you navigate how to troubleshoot these and manufacturing deviations that impact viral safety. In this webinar learn about key risk areas in executing viral clearance studies, how to mitigate risks in designing viral clearance studies, and what to do next if you have insufficient clearance. |
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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 Strategic Enabler For Scaling Gene Therapies | Article | AGC Biologics | Platform-based manufacturing uses standardized, pre-qualified workflows and analytics that reduce variability, simplify regulatory submissions, and accelerate the path to commercial success. |
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| Selecting A CDMO For Custom Activated PEGs | White Paper | MilliporeSigma | Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation. |
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| Seamless Onshoring From China-Based CDMO | Case Study | Avid Bioservices | Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program. |
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| Rapid, Reliable Technology Transfer | Article | WuXi Biologics | Find out how structured planning, expert coordination, and risk‑focused execution speed tech transfer, improve consistency, and move biologics into manufacturing faster. |
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| Quality By Design (QbD) For Biologics From A CDMO Perspective | White Paper | By Claudia Berdugo-Davis, Ph.D. and Anurag S. Rathmore, Ph.D., Catalent | Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals. |
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| Webinar: Strategic Early Material Generation for Accelerated Process Development | Accelerating access to early-stage material is critical for efficient biologics development. In this webinar, Samsung Biologics shares its integrated approach to early material generation, aligning with cell line development to deliver scalable, production-relevant material faster. Learn how this strategy supports developability assessment, reduces variability, and enables efficient downstream activities, with case studies demonstrating improved timelines, resource use, and overall program success. Click here to learn more. |
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