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.
- Pushing The Boundaries In Cell Therapy: CAR-T Updates From EHA 2025
- Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN
- Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
- How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction
- Why 'Which Is Best?' Is The Wrong Question In CGT Development
- Understanding FDA's New National Priority Voucher Pilot Program
- The Latest Techniques And Technology For Differentiating Capsids
- Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Vaccine Manufacturing GettyImages-1384850913]( "Sterile Filtration And Quality Risk Management")
Sterile Filtration And Quality Risk ManagementProcess control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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![RNA-GettyImages-1411871727]( "Purity Analysis Methods For Synthetic Prime Editing Guide RNAs")
Purity Analysis Methods For Synthetic Prime Editing Guide RNAsDevelop a fast, easy workflow for the purity analysis of complex pegRNA molecules along with a robust denaturing technique for pegRNA with high levels of secondary structure.
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![Solving Challenges Puzzle Maze]( "RNA: The Next Era In Therapeutic Development")
RNA: The Next Era In Therapeutic DevelopmentReview the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.
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![GettyImages-136640925-vial-vaccine]( "The Value Of Peptones For Cost-Effective Vaccine Manufacturing")
The Value Of Peptones For Cost-Effective Vaccine ManufacturingPeptones offer a strategic solution to key biomanufacturing challenges by enhancing cell culture performance, improving yields, and reducing production costs.
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![GettyImages-1693748594 phone]( "Remote Patient Monitoring Using Mobile Health Technology")
Remote Patient Monitoring Using Mobile Health TechnologyThis study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.
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![CliniMACS Prodigy®]( "Manufacturing IPC/QC Of Gene-Engineered HSCs")
Manufacturing IPC/QC Of Gene-Engineered HSCsIn-process and quality control ensure consistent manufacturing of gene-engineered hematopoietic stem cells. Discover an engineering process that enhances production through viral transduction and integrated sampling pouches.
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![GettyImages-843764526-blood-sample-tube-aav-testing]( "A Novel Approach To Improving AAV Titers")
A Novel Approach To Improving AAV TitersAs demand for AAV-based therapies rises, optimizing production processes is essential. By utilizing existing technologies, tailored platforms, and optimized formulations, titers and productivity can be enhanced.
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![Scientist Laboratory sample pipette GettyImages-1354172647]( "Protein L Affinity Resin Is Ready To Move To Manufacturing")
Protein L Affinity Resin Is Ready To Move To ManufacturingDiscover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.
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![GettyImages-1426571837-vial-laboratory-pipette-equipment]( "Selecting A Platform Filter For High Concentration mAbs")
Selecting A Platform Filter For High Concentration mAbsRead more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.
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![iStock-941351188-lab-cleanroom-sterile]( "Advancing Cell Therapy Manufacturing: Rapid Sterility Testing")
Advancing Cell Therapy Manufacturing: Rapid Sterility TestingThe rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
NEWSLETTER ARCHIVE
- 07.03.25 -- New Podcast Episodes: Microbes, CGT Development, & FDA Engagement in Focus
- 07.03.25 -- Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More
- 07.02.25 -- Hope For People With Spinocerebellar Ataxia
- 07.01.25 -- STREAM Edition: De-Risk Your Path To Clinic With An AAV Suspension Platform
- 07.01.25 -- Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need
- Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN
- Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More
- Rethinking Academic Translation In CGT: Inside The RISE Framework At Mass General Brigham
- The Promise Of Focused Ultrasound For AAV Gene Therapy Delivery
- Unlocking The Potential Of iPSC Therapies In Regenerative Medicine
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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