Newsletter | September 1, 2026

09.01.26 -- Unlocking The Future Of Cell And Gene Therapies

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Webinar: Scaling AAV manufacturing to 1000 L: strategies for robust and reproducible production

Moving AAV manufacturing from development to commercial scale requires more than simply increasing volume. Discover how integrated cell line, media, and bioreactor strategies can optimize transient AAV production, improve process robustness, and maintain product quality. This Cytiva webinar shares scale-up insights and a 1,000 L case study showcasing practical approaches for accelerating manufacturing-ready viral vector production. Click here to learn more.

FOCUS ON MANUFACTURING

Unlocking The Future Of Cell And Gene Therapies

We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

 

 

Eliminating Persistent Cleanroom Mold: A Vaccine Facility Case Study

Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

 

Robotic Systems Shift Aseptic Drug Manufacturing To 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 for drug developers.

 

Synthetic Approaches Resolve DNA Production Bottlenecks In Cancer Vaccines

Personalized cancer vaccines face a DNA production bottleneck. Synthetic approaches speed timelines, boost consistency, and simplify workflows to deliver individualized therapies faster.

 

Why Advanced Off-Target Analysis Is Critical For CRISPR's Success

CRISPR is transforming medicine, but precision remains critical. Off-target effects pose ongoing safety challenges, driving the need for rigorous, multidimensional evaluation strategies.

 

Lessons From Building Multi-Matrix qPCR Assays For AAV Vector Shedding

AAV gene therapy shedding assays demand matrix-specific extraction and rigorous validation across blood, semen, urine, and saliva. Uncover the strategies that ensure reliable qPCR data across biological matrices.

 

4 Considerations For Overcoming Challenges In Gene Therapy Testing

With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

 

The Next Frontier: Industrializing Cell Therapy Manufacturing

Discover how leveraging platform processes can enable flexible service at each level – pre-clinical through commercial – and reduce development timelines and costs on the clear path to market.

 

Characterizing AAV Payload With GMP-Compliant svAUC

Ensuring AAV quality starts with payload characterization. Investigate why conventional methods may miss key capsid population insights and how GMP-compliant svAUC provides a better evaluation path.

 

The Power Of A Platform Process For Lentiviral Vectors

A robust platform process can help ensure therapeutic efficacy and supply chain security for LVV-based products, as well as support aggressive development and commercialization timelines.

 

Process Intensification Strategy Reduces Costs In Biomanufacturing

Explore two projects that a focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

 

Quick Detection Of Microorganisms With Membrane Filtration

The membrane filter technique offers a cost‑effective way to detect microbial contamination. See how it enables rapid detection and allows precise species identification using selective media.

 

Unlocking Durable Allogeneic Cell Therapy And Overcoming Immune Rejection

Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.

 

Tips For Designing A Single-Use Manifold For Advanced Therapies

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

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Webinar: Challenges and Opportunities for MSC Expansion Workflows

Join us to explore scalable strategies for mesenchymal stem/stromal cell (MSC) expansion. This presentation will examine how Corning® HYPERStack® technology enables high-density cell culture while supporting efficiency, consistency, and reproducible performance. Gain practical insights and lessons learned from MSC expansion workflows, along with key process considerations for improving reproducibility, streamlining operations, and supporting manufacturing scale-up across evolving cell therapy applications. Click here to learn more.

MANUFACTURING SOLUTIONS

Recipe Importer Tool - Emerson

Negative, Total Exhaust Containment Isolator - Esco Lifesciences

Separation Tubular Bowl Cell Processing Platform - CARR Biosystems

Automated, Single-Use Systems For TFF At Multiple Scales - Cytiva

Pharmaceutical Cleanroom Components - AES Cleanroom Technology

Digital PCR System And 21 CFR Part 11 Regulations - QIAGEN

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