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.
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Strategic Synthesis Of ASGCT And ASCO 2026
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages- 1346675538 research]( "Guide To Seeding, Expanding, And Harvesting Stem Cells")
Guide To Seeding, Expanding, And Harvesting Stem CellsInvestigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.
-
![Supply Chain Management GettyImages-1304746031]( "The Unique Challenges Of The Cell & Gene Therapy Supply Chain")
The Unique Challenges Of The Cell & Gene Therapy Supply ChainCell and gene therapies present unique logistical challenges for the supply chain, requiring careful consideration of factors like shelf life, packaging, temperature, and chain of custody.
-
![GettyImages-1213680755-scientist-gloves-assay-cell-culture]( "Faster, Cheaper Cell Therapy with At‑Line QC")
Faster, Cheaper Cell Therapy with At‑Line QCAutomated at‑line immunophenotyping QC streamlines cell therapy manufacturing, cutting turnaround time and cost while aligning with conventional methods and enabling scalable, reliable workflows.
-
![GettyImages-1218745370 cleanroom, disinfecting, lab]( "Contamination In The Shadows: Risks Lurking From Environmental Issues")
Contamination In The Shadows: Risks Lurking From Environmental IssuesDiscover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
-
![GettyImages-1132960495 EU European Union flag]( "Understanding The EU Regulatory Landscape For Cell And Gene Therapies")
Understanding The EU Regulatory Landscape For Cell And Gene TherapiesEU approval for cell and gene therapies isn't just a different process, it's a different playbook. Here's what US manufacturers need to know before they engage.
-
![GettyImages-931069642 mAb, monoclonal antibodies]( "Empowering Antibody Discovery With ProSpeed™")
Empowering Antibody Discovery With ProSpeed™Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.
-
![GettyImages-1068302874-3d-cells-culture]( "A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived Exosomes")
A Scalable Manufacturing Platform For The Purification Of Stem Cell Derived ExosomesEV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for therapeutic exosome programs and allow for maximum exosome recovery.
-
![GettyImages-1663374966-lab-microscope-mask-research-study]( "Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape")
Navigating Project Optimus And The Rapidly Changing Oncology Development LandscapeProject Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
-
![GettyImages-1914829121-rna-strands-molecule]( "Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines")
Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP VaccinesDiscover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
-
![GettyImages-1585548490-modular-facility-laboratory-drug-development]( "The Open Standard For Plug-And-Produce")
The Open Standard For Plug-And-ProduceTake a look at how standardized, modular production simplifies line integration, reduces engineering effort, and enables faster changeovers. Ideal for teams seeking flexible manufacturing models.
NEWSLETTER ARCHIVE
- 06.16.26 -- STREAM Edition: When Should CGT Companies Keep Manufacturing In-House?
- 06.16.26 -- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- 06.15.26 -- Discover The Capabilities Driving Next-Generation Biologics
- 06.15.26 -- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- 06.13.26 -- Cell & Gene Newsletter - Best Of May
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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.
More Content Collections
