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| Viral Vector Based Gene Therapy Drug Products: The Right Primary Container | Packaging plays a critical role in ensuring the stability, safety, and efficacy of viral vector-based gene therapies. Key considerations include container closure integrity, low chemical reactivity, minimal extractables and leachables, reduced surface adsorption, and particulate control, particularly during ultra-low-temperature storage. Cyclic Olefin Polymer (COP) CZ vials address these challenges through high inertness, robust integrity, and compatibility with modern fill-finish processes, making them a reliable containment solution for advanced gene therapy products. |
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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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| From LAL To rFC: The Evolution Of Endotoxin Testing | Application Note | By Thomas Lehman, Ph.D., and Tessa Patton, Eurofins | Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance. |
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| Scalable Protein Expression With Pichia Pastoris | Webinar | Lonza | Examine how advanced yeast expression systems accelerate development timelines through simple fermentation workflows and highly adaptable processes tailored to specific biomanufacturing goals. |
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| Target Product Profile (TPP) Explained | Article | PharmaSource | Understand how a well-defined profile aligns early development strategies, aids cross-functional decision-making, and creates a transparent roadmap from initial discovery to market launch. |
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| The Advantages Of Off-The-Shelf GMP iPSCs With A DMF | Webinar | Applied StemCell | Explore how using off-the-shelf, clinical-grade iPSC lines backed by a Drug Master File simplifies regulatory filings, reduces development expenses, and shortens timelines to human trials. |
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