Newsletter | August 29, 2024

08.29.24 -- CGT Regulatory Update And Outlook With Dark Horse Consulting

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FEATURED EDITORIAL

CGT Regulatory Update And Outlook With Dark Horse Consulting

Dark Horse Consulting Group (DHC)'s Kimberly Benton, Ph.D. joins Erin Harris to discuss Biologics License Applications (BLAs) of recent approvals as well as those currently under review. Benton shares information about FDA Draft Guidances, including Platform Technology Designation Program for Drug Development: Guidance for Industry.

INDUSTRY INSIGHTS

RNA: The Next Era In Therapeutic Development

Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

Safer Single-Use Materials To Enhance Advanced Therapy Manufacturing

Single-use tech suppliers must collaborate with advanced therapy manufacturers to mitigate manufacturing risks and ensure chemical composition meets safety and efficacy standards.

Making CGT More Accessible In The Treatment Of Solid Tumors

Examine the evolving landscape of cell and gene therapies, with a focus on expanding access, especially for treating solid tumors outside traditional academic settings.

Analyzing Serum-Free Media For Cell Therapy Applications

Identifying critical factors and their concentrations with an eye towards designing an ideally formulated, defined serum-free medium should be carried out using rational and systematic approaches.

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.

Developing A Scalable RNA-LNP Drug Product For Clinical Translation

Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.

Find The Right T Cell Expansion And Phenotype Balance For Cell Therapy

Explore this study that works to determine the optimal concentrations of IL-7 and IL-15 for T cell expansion, as well as how to produce the desired phenotype while requiring less protein.

Study Of Small Bioreactor Expansion Kinetics During Expansion Protocol

Mesenchymal stem cells have been used to show equivalent expansion kinetics during a 7-day expansion protocol on both the small and standard bioreactors revealing efficiency differences.

How Continuous Improvement Ethos Serves Patients And Clients

Discover how years of experience bolstered by continuous improvement efforts, enable hybrid clinical trial execution, from in-home clinical visits to site networks and digital platforms and technology.

Capabilities And Opportunities Of Innovative Cell Processing System In CGT

Uncover how this system can automate several steps of your cell therapy workflow while achieving high efficiency, how to optimize cell recovery during harvesting, and more.

How Real-Time Data Is Transforming Pharmaceutical Manufacturing

Better understand the forces behind digital transformation, and learn how a new manufacturing excellence platform can be used to achieve real-time process transparency and insights.

Highly Efficient Production Of Adeno-Associated Virus

This study evaluates the performance of a flexible, automated fixed bed reactor (FBR) system during AAV production, comparing it with a similar FBR system and 2D cell culture controls.

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