Newsletter | May 14, 2026

05.14.26 -- Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

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Webinar: Addressing Manufacturing and Characterization Challenges and Opportunities with Novel AAV Capsids

Novel AAV capsids are advancing gene therapy while increasing complexity. Join Viralgen, Genosafe, and DarkHorse Consulting to explore real-world strategies for manufacturing, optimizing analytical methods, and navigating evolving regulatory expectations. Gain practical insights into improving transduction, reducing immunogenicity, and adapting assays to ensure novel capsids are fit for purpose, scalable, and ready for clinical success. Click here to learn more.

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Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

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.

Delivering Therapies Without Delay Using An Integrated Platform

Eliminate the gap between R&D and cGMP manufacturing with mirrored environments. This strategy bypasses clinical transfer delays to speed up IND submissions and improve patient access timelines.

Optimizing Biotherapeutic Protein Expression With CHO Vector Technology

High-strength synthetic gene promoters can enhance expression stability and titers. Discover how these vector technologies support efficient biomanufacturing without compromising product quality.

The Slow Drift Toward Variability And The Case For Standardization

Small early-stage decisions often lead to hidden variability at scale. Learn why standardization is essential for long-term stability, reproducibility, and maintaining regulatory confidence.

De-Risk Nucleic Acid Therapeutics Through Strategic Outsourcing

Bringing a nucleic acid therapy to market requires specialized formulation and development knowledge. Innovators need rigorous analytical and formulation strategies to achieve stability and quality.

End-To-End Custom Media From The Right Formulation To GMP

Uncover how integrated custom media solutions can accelerate the path to manufacturing success, supporting both clients with established formulations and those seeking new designs.

Synthetic DNA As A Scalable Alternative For Viral Vector Manufacturing

Launching nucleic acid therapies requires specialized formulation expertise. Implement rigorous analytical strategies to ensure product stability and quality throughout the development cycle.

Efficient Mammalian Cell Engineering Using Pre-Engineered Platforms

Achieve inducible expression in as little as four to six weeks. Utilizing pre-engineered landing pads significantly reduces the time and effort required for donor plasmid development phases.

Designing Cell Therapy Analytical Programs For Regulatory Success

Expedited cell therapy pathways demand early, reliable analytical development to ensure robust data, regulatory confidence, and smooth transitions from discovery through clinical stages without costly delays.

Building On Pittsburgh's Legacy To Industrialize Advanced Therapies

Pittsburgh's industrial roots and growing biotech hub unite to scale advanced therapies through new purpose‑built biomanufacturing, automation, and workforce development.

12.5x Titer Boost Accelerates CAR-T Program To IND Filing

Plasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.

SPONSOR

Bioprocessing Summit-Boston

The Bioprocessing Summit unites a global community of scientists, engineers, and executives driving innovation and digitalization across process development, scale-up, quality, and analytics for biologics, antibodies, cell and gene, RNA, and oligonucleotide therapies. Join us August 10-13 in Boston to explore how technology, data, and AI are reshaping every stage of the bioprocessing journey.

OUTSOURCING SOLUTIONS

Powering Gene Therapy Progress With High-Performance LVVs - Vector BioMed

High Quality End-To-End Microbial Services - 3PBIOVIAN

Freeze Your Device Design With This New PFA System - West Pharmaceutical Services, Inc.

Partnering To Advance Therapeutic Innovation: Clinical Trial Solutions - Eurofins

Fast Track Your Therapy With Our Viral Vector Services - SK pharmteco

Services For Advancing mRNA-LNPs From Bench To Clinic - Cytiva

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