Newsletter | November 26, 2024

11.26.24 -- Considerations For Potency Assurance Of CGT Products

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Despite significant advances, challenges remain in optimizing AAV-based treatments for broader clinical application. Join Cell & Gene Live on December 10th for a discussion on the latest developments in AAV vector design, manufacturing processes, and clinical strategies as well as key issues such as immunogenicity and regulatory considerations that are shaping the future of AAV gene therapies. Registration is free thanks to the support of Roche CustomBiotech.

FOCUS ON MANUFACTURING

Considerations For Potency Assurance Of CGT Products

Confused about the FDA's draft guidance on potency assays for cell and gene therapy products? Let’s clarify a few important points and discuss some key considerations.

6 Reasons To Automate Your Sample Preparation Workflows

With a growing labor shortage in the biotechnology industry, the necessity to do larger-scale sample preparation with fewer skilled hands is increasing, putting a strain on many laboratories.

How Digital Quality Management Is Transforming Manufacturing

How can pharma manufacturing adapt to be more agile, data-driven, and prepared for the future? The solution lies in digital transformation.

4 Steps To Develop A Cell Therapy Roadmap

What is a manufacturing roadmap? When should it be developed and implemented? And how can it improve your cell therapy manufacturing processes?

Clinical-Scale Expansion Of Peripheral Blood Derived γδ T Cells

See how billions of γδ T cells can be generated from peripheral blood mononuclear cells with two distinct activation methods – a chemically defined, non-animal origin, serum-free medium, in a motion platform.

Maintain Sterility And Ease In CGT Development, Including Cryopreservation

Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.

Technology Transfer Strategies: Fill-Finish Automation And Robotics

Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Learn about the role that capable fill-finish solutions play in this process.

Improve Speed To Market By Mitigating Vial And Stopper Incompatibility

Explore two studies showing that a properly-assembled vial containment system ensures good CCI performance with stoppers of a given elastomer, regardless of configuration, size, or vial style.

Addressing Cell Line Development Bottlenecks

The following study results demonstrate InstiGRO reagents' ability to substantially improve the cloning phase of cell line development workflows when manufacturing protein biologics and viral vectors.

A Novel Transfection System For Cell And Gene Therapy Applications

An innovative transfection system addresses common production challenges by offering higher AAV titers, improved percent-full AAV capsids, and a straightforward workflow for AAV production platforms.

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Webinar: Rapid Process Development And Technical Support For AAV Scaleup

This webinar highlights the challenges and advancements in manufacturing Adeno-Associated Viruses (AAVs) for gene therapy, including optimized cell lines, scalable systems, and purification methods. Thermo Fisher's support for innovators is showcased through a case study on rapid scale-up, media diversity, and flexible culturing options. Learn how Thermo Fisher aids startups in achieving efficient, scalable AAV production. Click here to learn more.

MANUFACTURING SOLUTIONS

How To Maintain A Nuclease Free Environment During mRNA Production - Cytiva

Modern MES Software For Drug Manufacturing - MasterControl, Inc.

DEHP-Free Fluid Transfer Bags - Charter Medical

Freezing Shells: Reusable, Plastic Shell Solution - Entegris, Inc.

Software Package For GMP-Regulated Environments - Refeyn

VirusExpress Lentivirus Production Platform - MilliporeSigma

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