Newsletter | May 30, 2023

05.30.23 -- FDA's Digital Health Tech Framework Addresses Challenges

 
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Advance Cell And Gene Therapies With Next Generation Cryopreservation

Learn about a next-generation cryoprotectant agent carving a new path to accelerate optimal treatments for patients in the overall field of biologics.

Trends In Cold Chain Storage For Biologics

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.

How To Reduce The Complexity Of Single-Use Systems

Explore five key benefits of genderless aseptic connectors and how they can lead to more flexibility, reduced risk, and lower costs for your organization.

Why Site And Partner Communications Are Critical To Autologous Cell Therapy Clinical Trials

The dynamic nature of inherently complex cell therapy-focused clinical trials requires individuals with a keen understanding of site and partner needs communicating effectively.

Manufacturing Strategies To Industrialize Autologous Cell Therapies

While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.

A Guide To In Silico Modeling And Simulation

Discover how in silico trials meet ethical codes and can be used to evaluate drug candidates.

The Role Of Real-World Evidence To Support U.S. FDA And TGA Registrations

Real-world evidence (RWE) can contribute valuable information to new medicine registrations, particularly for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies.

Expert IND Publishing Support For An Understaffed Regulatory Team

Discover how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team capable of accommodating ad hoc publishing requests.

Where T Cells Thrive

Explore the Quantum Flex Cell Expansion System as a robust environment to advance your T cell cultures from preclinical development to commercialization.

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