Downloads
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Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
12/17/2025
Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
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Overcoming Regulatory Hurdles In AAV Production
12/16/2025
Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Explore how specialized assays and strategic partnerships streamline compliance.
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From Lab To Commercialization: Simplifying Bioprocess Scale-Up
12/16/2025
Explore how unique cuboid geometries and advanced mixing dynamics create consistent performance from the bench to commercial manufacturing, ensuring flexibility and improved productivity.
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November 2025 — CDMO Opportunities And Threats Report
12/16/2025
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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Minaris Advanced Therapies Overview
12/15/2025
Global cell and gene therapy CDMO providing GMP manufacturing, testing, and development services with commercial success, regulatory expertise, and advanced multi‑modality capabilities.
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Cell Therapy Lot Release Package
12/15/2025
Comprehensive cGMP-compliant cell therapy lot release testing includes identity, potency, safety, and characterization assays, ensuring regulatory compliance and timely product release for advanced therapies.
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Contamination Control And Risk Assessment Advisory Services
12/15/2025
PMS is here to help with all your cleanroom contamination needs.
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Particle Loss Studies
12/15/2025
Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.
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Bridging The Gap Between Product Readiness And Equipment Availability
12/15/2025
Discover how manual precision at scale bridges packaging gaps, accelerates product launches, and ensures uninterrupted supply to deliver quality when automated equipment isn’t yet operational.
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Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing
12/15/2025
How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?