Newsletter | March 26, 2024

03.26.24 -- FDA's 2024 Regulatory Outlook Recap

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Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne.

FROM THE EDITOR

Video Clips From Cell & Gene Live: 2024 Regulatory Outlook

Our recent Cell & Gene Live, 2024 Regulatory Outlook With FDA's Drs. Peter Marks and Nicole Verdun, was a chock full of data and valuable information. I've broken down the full-length presentation into bite-sized video clips that you can view at your convenience.

INDUSTRY INSIGHTS

Building A Robust Cell And Gene Therapy Supply Chain

As cell therapies develop and become more commercialized, manufacturers must adopt a sophisticated supply chain that provides the necessary materials and technologies to support therapeutic development.

Which Cell Culture Media Is Right For Your T Cells?

Serum-free media may yield lower CAR-T efficacies, so understanding how to optimize the media to improve the therapy is a necessary step.

Safer Single-Use Materials To Enhance Advanced Therapy Manufacturing

Single-use tech suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain the safety and efficacy of new treatments.

Increasing mRNA Capabilities And Capacity

The growing mRNA vaccine market ― projected to reach $127.3 billion by 2027 ― is fueling high demand for mRNA, which has resulted in a critical need to address mRNA manufacturing bottlenecks.

Innovation, Tech, And Collaboration In Advanced Materials

Demands for flexible, scalable, and cost-effective manufacturing are prompting cell and gene therapy manufacturers and CDMOs to implement single-use technology for manufacturing their therapies.

Reproducible And Scalable System For CHO Cell Culture

Explore a demonstration of a 250mL bioreactor system designed to run off-site in the cloud, as well as the results of its use in both cell culture and fermentation applications.

Optimizing Cell Harvest For Allogeneic Therapies Using Tailored Tech

For many applications, cutting-edge centrifugation technologies can achieve cell harvest optimization, providing a low-shear, high-yield process that is tightly controlled and highly reproducible.

The Starring Role Of Stirred Tank Bioreactors

Stirred-tank bioreactors have emerged in recent years as the optimal platform to optimize (stem) cell culturing, raising their potential in the cell and gene therapy industry.

Rapid Rise And Promising Future Of CRISPR Cell And Gene Therapies

What are cell and gene therapies and how has the invention of CRISPR revolutionized the industry? Learn about the history of these therapies and life-changing treatments on the horizon.

Controls On Demand: Revolutionizing The Drug Discovery Pipeline

Discover how products developed to tackle the absence of consistent reference material for cell-based assays in drug development became a successful solution.

Best Aseptic Practices For The Future Of Cell And Gene Therapies

Unearth best aseptic practices for cell and gene therapy production that will be foundational to the ongoing development of these therapies as well as their successful manufacturing operations.

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Webinar: Advancing Development of New Oncology Therapies: Aligning with FDA’s Project FrontRunner

Join us on April 4th as we explore the risks and rewards of providing groundbreaking cancer treatments to patients with early advanced metastatic cancer. Our discussion will navigate the complexities of advancing treatments sooner, specifically the impacts on patients, investigators, and drug developers. Click here to learn more.

SOLUTIONS

SecurityLink HPLC/UHPLC Fingertight Fittings

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GMP Certified Solution For Cell Therapy

Streamlining Change Control With Unified Quality

Auto-Populate eCRFs On Study Day One

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