Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Can A Biotech Create A CDMO Market?
- Why Are Life Science Companies So Poorly Prepared For RIM's Future?
- April 2026 — CDMO Opportunities And Threats Report
- Cell And Gene Therapies: The Emerging Reality For Scalable Market Readiness
- Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
- Why Your MES RFP Is Failing Before It Starts
- Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1767170794-GLP-1-peptide-chain]( "History Of Peptides In Medicine: From Early Chemistry To The GLP-1 Era")
History Of Peptides In Medicine: From Early Chemistry To The GLP-1 EraPeptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.
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![GettyImages-1339300422 CAR T-Cell Immunotherapy]( "How To Successfully Isolate Your T Cells")
How To Successfully Isolate Your T CellsExplore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Fast And Accurate Detection Of Alzheimer's Disease Targets")
Fast And Accurate Detection Of Alzheimer's Disease TargetsIn this study, the detection of three Alzheimer’s disease targets are highlighted: Human BDNF (Brain-derived neurotrophic factor), Tau, and TREM2 (Triggering receptor expressed on myeloid cells 2).
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![clinical-compliance-GettyImages-2259718661]( "10 Clinical Research Practices That Feel Like Compliance (But Aren't)")
10 Clinical Research Practices That Feel Like Compliance (But Aren't)Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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![GettyImages-657049072 vaccine, pharma]( "Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility")
Streamline Your mAb Manufacturing With Strategic Development And CDMO CompatibilityThough the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
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![GettyImages-1346675513 lab materials]( "Criteria For Effective Bioprocess Scale-Up")
Criteria For Effective Bioprocess Scale-UpDiscover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.
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![GettyImages-1132766141 patient recruitment]( "Recruiting & Retaining More Patients Per Site:")
Recruiting & Retaining More Patients Per Site:Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
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![Compliance Regulation Business Technology risk management-GettyImages-1433535736]( "Simplify CAPA In 7 Steps")
Simplify CAPA In 7 StepsDiscover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.
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![Hollow Fiber AAV App Note]( "Why Membrane Matters In AAV Filtration")
Why Membrane Matters In AAV FiltrationGene therapy is revolutionizing medicine to offer one-time treatments. Find out how AAV vectors are leading the way to optimize production and make these life-changing therapies accessible.
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![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.
NEWSLETTER ARCHIVE
- 05.15.26 -- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- 05.14.26 -- Discover critical components for fluid management and flow control
- 05.14.26 -- Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not
- 05.13.26 -- Manufacturing Moves Shaping Advanced Therapies
- 05.13.26 -- How MTP Is Transforming Pharma Production Lines
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Target Selection Drives The Future Of CAR T Therapy In Solid Tumors
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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