Newsletter | October 12, 2026

10.12.26 -- CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers

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Autologous CAR T-cell therapy offers enormous potential, but patient-specific manufacturing presents challenges in turnaround time, quality, scalability, and technology transfer. In this Cell & Gene Live on Oct. 15, 2026 at 11 AM ET, Mayo Clinic experts will share practical insights on overcoming production bottlenecks, strengthening quality-focused processes, partnering with CDMOs, evaluating alternative platforms, and making early CMC decisions that support clinical execution and commercial readiness. Registration is free.

FOCUS ON OUTSOURCING

CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers

Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

 

FOCUS ON OUTSOURCING

 

Navigating Complex Regulatory Risk In Biologics Safety

Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

 

Vial Containment Systems For Gene Therapies

Tests show cyclic olefin polymer vials match or exceed borosilicate glass in vector recovery, closure integrity, and particle safety at ultra-low storage temperatures.

 

A Model To Produce CAR-T, Anywhere

Standardized point-of-care manufacturing overcomes cell therapy access, cost, and supply challenges, enabling regional centers to efficiently deliver high-quality treatments.

 

Put Your AAV On The Fast-Track To The Clinic

Review an innovative method to fast-tracking AAVs through a platform approach that easily scales as the project progresses to late-stage GMP production and to market.

 

Why Your Bioanalysis Bottleneck Is Costing You More Than You Think

This piece explains why turnaround time is a strategic variable, where speed is truly achievable, and how automation reshapes the path from sample submission to decision‑ready data.

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Webinar: Precision at Scale: Optimizing Cell-Free DNA Manufacturing for Next-Generation mRNA Vaccines and Therapeutics

As mRNA vaccines and therapeutics advance, scalable, consistent DNA templates are increasingly important. This 4basebio webinar explores 4basebio’s cell-free, enzymatic synthetic DNA platform and how it can support high-quality IVT templates, reduce impurities and aberrant RNA species, and enable stable, continuous poly(A) sequences up to 180 nucleotides. Discover new approaches for next-generation mRNA manufacturing. Click here to learn more.

OUTSOURCING SOLUTIONS

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Give Your Gene Therapy The Kickstart It Deserves - Viralgen

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Plasmid DNA Platform - 3PBIOVIAN

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Custom Circle Gene Editing - Touchlight

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