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.
- Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies
- Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![RNA, ribonucleic acid-GettyImages-2195556279]( "De-Risk Nucleic Acid Therapeutics Through Strategic Outsourcing")
De-Risk Nucleic Acid Therapeutics Through Strategic OutsourcingBringing a nucleic acid therapy to market requires specialized formulation and development knowledge. Innovators need rigorous analytical and formulation strategies to achieve stability and quality.
-
![The Benzonase® Endonuclease Success Story]( "Business Continuity Management: The Benzonase® Endonuclease Success Story")
Business Continuity Management: The Benzonase® Endonuclease Success StoryBusiness continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
-
![GettyImages-1354172647-scientist-in-lab-with-flasks-pipette]( "Where Speed Meets Complexity In Bioprocess Development")
Where Speed Meets Complexity In Bioprocess DevelopmentBioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.
-
![GettyImages-687868860-Test tubes_Vial_Lab]( "Control Strategies And Method Development For Nitrosamines In APIs And Drug Products")
Control Strategies And Method Development For Nitrosamines In APIs And Drug ProductsExplore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.
-
![Car-T cell attacking cancer cell-GettyImages-2252478724]( "CAR T Cell Generation From Cryopreserved Leukapheresis Products")
CAR T Cell Generation From Cryopreserved Leukapheresis ProductsA seven‑day CAR T cell manufacturing workflow shows how cryopreserved leukapheresis material can deliver high viability and strong antitumor activity, offering a more flexible path for production.
-
![GettyImages-1987435635 research, planning]( "Rescuing A Global Program For NDA Success")
Rescuing A Global Program For NDA SuccessExplore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
-
![GettyImages-1327318287 cells]( "hiPSC Aggregate Expansion In Stirred-Tank Bioreactors")
hiPSC Aggregate Expansion In Stirred-Tank BioreactorsLearn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.
-
![GettyImages-675822670 clean room, lab, scientist]( "Data-Driven CHO Bioprocess Optimization And Scale-Up")
Data-Driven CHO Bioprocess Optimization And Scale-UpLearn how at-line cell culture media analysis enhances mAb production by refining nutrient feed strategies, reducing toxic metabolites, and improving yields while lowering costs.
-
![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-1590576166 cells, research, lab, assay]( "Stability Of Supplemented PRIME-XV T Cell CDM At Room Temperature")
Stability Of Supplemented PRIME-XV T Cell CDM At Room TemperatureGain insight into how a supplemented medium stored at room temperature for up to 72 hours maintained T cell expansion performance, showing consistent viability and marker expression.
NEWSLETTER ARCHIVE
- 07.31.26 -- Supply Chain Orchestration, Priorities For Smaller CGT Biotechs
- 07.30.26 -- Innovations To Support Scale And Efficiency In Your Process
- 07.30.26 -- Addressing The Particulate Challenge In Cell Therapy Products
- 07.29.26 -- Key Considerations for Combination Product Development
- 07.29.26 -- Full FDA Approval For TECELRA Is More Than A Regulatory Win For Solid Tumors
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
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
