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Webinar: USP <665>: Testing Of Plastic Components And Systems Used In Pharmaceutical Manufacturing
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How do you build a defensible USP <665> extraction study? This Pace Life Sciences webinar explores the risk-based framework for evaluating plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing. Learn how to determine scope, assign risk, select extraction conditions, interpret extractables and leachables, and develop complete study packages that support regulatory expectations and product safety. Click here to learn more.
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Advancing Sterile Injectable Manufacturing
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Video | August Bioservices
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A U.S.-based sterile injectable CDMO delivering small and large molecule manufacturing, supported by advanced aseptic technologies, integrated quality systems, and commercial-ready capabilities.
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By Louis Garguilo, Chief Editor, Outsourced Pharma
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A number of patients report receiving half a pill in a blister pack of their prescribed medicine. The initial sponsor reaction is to place the problem at an external partner’s production or packaging line. But overall responsibility lies with the sponsor, and the true extent of the problem is hard to detect. Enter AI. Says Damiano Dragone, a long-term Quality expert, AI and biopharma professionals throughout the supply chain can join in a new “logic and creativity" to improve our industry on behalf of patients.
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August 2026 — CDMO Opportunities And Threats Report
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By GlobalData
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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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INDUSTRY INSIGHTS CONTINUED
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Winning With Analytical Strategy
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Article | LOTTE Biologics
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A strategy connects process parameters, critical quality attributes, and manufacturing performance to support informed decisions across biologics development, scale-up, transfer, and commercialization.
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Designing Successful Viral Clearance Studies
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White Paper | By Kathryn Martin Remington, Ph.D., and Kate Smith, MilliporeSigma
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Review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.
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Improving Accuracy In Size Measurements Of Nanomedicine
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Case Study | By Dr. Maria Marioli, Ardena
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Precise particle sizing is key to formulation success. Advanced analytics overcome DLS limitations, providing reliable data that reduces risk and supports long-term product stability.
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Device Design For Usability And Risk Reduction
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Article | By Dr. Sylvine Raverdy-Wilson, BD Medical - Pharmaceutical Systems
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Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.
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Understanding The Lean Biosimilar Model
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Article | By Dr. Anna Ducka and Krishna Sarikonda, Rezon Bio
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Characterized by fewer clinical studies, analytical characterization, and integrated process design, the lean biosimilar development model expands market access and brings treatment options faster.
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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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