Newsletter | December 2, 2025

12.02.25 -- How Early Manufacturing Decisions Shape Long-Term Success

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Webinar: Overcoming Regulatory Hurdles in AAV Production

As CGT advances, regulatory expectations continue rising—especially around demonstrating clearance of residual reagents in viral vector production. In this webinar, Miguel Dominguez and Lloyd Achirem from Mirus Bio (part of MilliporeSigma) share how strategic partnerships and a newly developed residual reagent assay simplify submissions and strengthen quality assurance. Learn how their practical innovations support more efficient, compliant, and future-ready AAV manufacturing. Click here to learn more.

FOCUS ON MANUFACTURING

How Early Manufacturing Decisions Shape Long-Term Success

Early manufacturing choices in cell and gene therapy shape long-term clinical and commercial success, so leaders from Allogene and Verismo emphasized that both autologous and allogeneic developers should prioritize process simplicity, risk-based decision-making, and adaptable manufacturing as therapies move from concept to clinic.

The Rise In Aseptic Manufacturing Solutions With Smaller Footprints

Aseptic drug manufacturing is going small. Discover how advanced robotic and automated systems with smaller footprints are changing the landscape and boosting accessibility.

2026 Trends With Single-Use Bottles In Bioprocessing

Despite the rise of single-use bags, bottles continue to play a significant role in bioprocessing for the production of robust products. New closed-system technologies and sustainable materials could boost their popularity.

Plan And Optimize Your Western Blot Experiments

Western blotting identifies specific proteins in complex samples, using gel electrophoresis and antibody probing. Find out how it reveals protein presence, abundance, and size.

Predicting The Performance Of Perfusion Media In A Continuous Bioreactor

Small-scale perfusion-mimic models can effectively predict media performance in continuous bioreactors to help optimize cell density, productivity, and scalability for CHO cell lines.

Automating Ancillary Processes: Closing Bottlenecks In CGT Manufacturing

Watch as speakers share a variety of challenges encountered when closing and automating ancillary processes, and how closed automated platforms improved scalability and reproducibility.

The Shift To GMP-Compliant Automation In CGT Manufacturing

Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

Enabling MSC Harvest, Wash, And Concentration

A study demonstrates how a low-shear, closed-system centrifuge achieved over 90% MSC recovery and minimized viability loss, supporting scalable cell therapy manufacturing.

Advancements In Aseptic Connection Technologies

Expand your knowledge on the latest innovation in the sterile connector space including the new 1.5” flow path connector, disconnection solution, and more.

What Is A Viral Vector?

Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks.

Vial Containment Systems For Gene Therapies: Container Closure Integrity

Maintenance of CCI at ultra-low temperature is a necessity for a gene therapy vial containment system. Systems comprising cyclic olefin polymer vials and elastomer stoppers with a barrier film were evaluated over time.

Enhancing CRISPR Knock-In And Knock-Out

Achieve scalable, non-viral CRISPR delivery for T cells. The next-generation electroporation platform provides robust, efficient gene editing from small to large-scale volumes.

Studies On CHO Cell Culture In X-ray Single-Use Bioreactors

In cell culture, the leakage of toxic or inhibitory chemicals from single-use bioreactors has become a growing concern. Explore recommendations for leachable studies.

Rev-Up AAV Genome Production In Upstream Manufacturing

By increasing recombinant AAV titers, this AAV enhancer can help reduce upstream manufacturing costs and lower the cost per therapeutic dose.

Reducing CAR-T Manufacturing Costs And Duration

Addressing critical hurdles in CAR-T cell production, this research demonstrates methods to enhance efficiency and reduce expenses for broader patient benefit.

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Join us for this Cell & Gene Live when Erin Harris, Chief Editor of Cell & Gene welcomes Steve Awad, Principal Director, Supply Chain & Industry X — Life Sciences at Accenture, and Michael Blackton MBA, VP, Manufacturing and Supply at Ocugen to unpack what CGT developers need to know about efficient, compliant dual- or multi-modal manufacturing even when production is outsourced. Registration is free thanks to support from Ecolab Life Sciences.

MANUFACTURING SOLUTIONS

Stackable CO2 Incubator - PHC Corporation of North America

Single-Use Solutions: Cell Growth - Charter Medical

A Scaled-Down Solution For Simple, Robust Upstream Intensification - Repligen

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