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.
- Building Sustainable Biopharma Supply Chains Starts With Procurement
- Sustainable Facility Design Brings Bayer Instant Savings
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
- Why You Should Measure Comparability Debt Before Ever Starting A Study
- What FDA Inspectors Want From Your OOS File
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Pharmaceutical Bottle Manufacturing-GettyImages-1460261322]( "Superior Performance Of Tubing In Extended Fill-Finish Applications")
Superior Performance Of Tubing In Extended Fill-Finish ApplicationsTubing durability plays a critical role in extended fill-finish operations, affecting fill counts, contamination risk, operational efficiency, and process reliability.
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![primary-drying-time-GettyImages-1464359399]( "SaniSure Clamp: Design And Technical Advantages")
SaniSure Clamp: Design And Technical AdvantagesTraditional sanitary clamps can create sealing inconsistencies with single-use components. Discover a compression-based approach that improves gasket performance and reduces leak risks.
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![GettyImages-941351234-Pharmaceutical_Factory_Worker_Manufacturing_Production_Sterile]( "SaniSure Clamp Pre And Post Gamma Extended Leak Tightness Study")
SaniSure Clamp Pre And Post Gamma Extended Leak Tightness StudyPressure and gamma irradiation testing demonstrated consistent, leak-tight connections without re-tightening for stored single-use assemblies.
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![bioprocess-facility-GettyImages-2286540867]( "Summary Of Gamma Irradiation Sterilization Validation")
Summary Of Gamma Irradiation Sterilization ValidationValidation, dose mapping, bioburden monitoring, and routine audits help ensure sterility assurance and support quality in bioprocess manufacturing.
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![sterile cleanroom protective gear]( "Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems")
Global Regulatory Harmonization: Comparisons In Aseptic Barrier SystemsCompare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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![GettyImages-1356993441 mRNA]( "Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals")
Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability GoalsExplore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.
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![GettyImages-1443975905 lab, analytics, technology]( "Demonstrating Bioprocess Scalability Through Platform Consistency")
Demonstrating Bioprocess Scalability Through Platform ConsistencyExplore how a unified bioreactor design enables consistent process performance from bench to production, minimizing scale-up risk while maintaining cell growth and yield.
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![GettyImages-1759287088 patient nurse consultation]( "Reducing The Burden Of Patient Retention And Improving Continuity")
Reducing The Burden Of Patient Retention And Improving ContinuityImmunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
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![2_PharmaSource_Conference_CDMO Live copy]( "CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture")
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And CultureDiscover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
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![GettyImages-1429676982 iPSC]( "Improving Methodologies For iPSC Manufacturing And Differentiation")
Improving Methodologies For iPSC Manufacturing And DifferentiationLearn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.
NEWSLETTER ARCHIVE
- 09.28.26 -- The Integrated Path To Injectable Success
- 09.28.26 -- Why You Should Measure Comparability Debt Before Ever Starting A Study
- 09.25.26 -- The Promise Of MRD-Guided CAR-T Treatment
- 09.24.26 -- OPCU Special CPHI Session: Trends Shaping Advanced Therapies
- 09.24.26 -- The Unspoken Truth About Cell Therapy Product Understanding
- Inside Scaling Next-Gen MSCs Without Scaling Risk
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
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