Newsletter | February 8, 2024

02.08.24 -- Evaluating Innovative Therapies And Making Sense Of New Data

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FEATURED EDITORIAL

Evaluating Innovative Therapies And Making Sense Of Emerging Data

Poseida Therapeutics' President and CEO, Kristin Yarema, Ph.D., details why allogenic CAR-T compares favorably with autologous CAR-T, and why, in many ways, allo has advantages that auto cannot hope to match.

2024 Regulatory Outlook With FDA's Drs. Peter Marks And Nicole Verdun

Explore the evolving regulatory landscape for cell and gene therapies in 2024 including the increasing speed availability of these therapies by enabling manufacturing processes and standards development.

INDUSTRY INSIGHTS

Trends In Next-Generation Delivery Technologies

Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

Rapid Cell Culture Media Analysis For C> Process Development

Experts discuss how to accelerate process analytics with fast nutrient screening at critical time points and the benefits of rapid media analysis in cell therapy development and viral vector production.

Presaturated Wipes: Ensuring Consistent Processes And Higher Quality

Cleaning surfaces and equipment in controlled environments have historically involved a variety of methods. Explore key takeaways from studies regarding the benefits of presaturated wipes.

Tailor-Made DNA Plasmids For Viral-Vector Manufacturing

The conventional approach to plasmid DNA design and construction is not amenable to fine-tuning the structure and properties of molecules. Consider this from-scratch method instead.

Adeno-Associated Virus: Enabling Genomic Medicine

Since the first rAAV-based therapy was approved by the FDA, application of gene therapies utilizing rAAV vectors has exploded and active clinical programs are being fast-tracked for clinical approval.

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 Need For Mass-Produced Spheroids

Researchers looking for reliable ways to recapitulate physiological conditions are turning to spheroids and other 3D objects, seeking ways to mass-produce 3D models for various applications.

Are Bioreactors The New ‘Fish Tanks’?

By exploring innovative approaches to scaling up animal cell growth in cutting-edge bioreactor systems, foodtech companies are poised to offer healthier, safer, more sustainable fish for consumers.

4 Considerations For Overcoming Challenges In Gene Therapy Testing

With continuously evolving gene therapy regulations, guidance, and limited time during development for testing, consider the four points this author makes when planning product-release testing.

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As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris.

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How To Overcome AAV Manufacturing Challenges

Modular Cleanrooms For Cell And Gene Therapy Drug Manufacturing

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Sterile Filtration Solutions For Single-Use Bioprocessing Systems

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