Newsletter | October 3, 2025

10.03.25 -- Key Considerations For Materials And Components Used In Manufacturing

SPONSOR

Join Cell & Gene Live on October 16 at 11am ET for a virtual panel discussion on Designing Early Manufacturing for Long-Term Success in CGT. Registration is free with support from Thermo Fisher Scientific.

FOCUS ON SUPPLY CHAIN

Key Considerations For Materials And Components Used In CGT Manufacturing

This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.

New Container Protects Bulk Frozen Biopharmaceuticals

Learn more about a flexible freeze container that maintains package integrity after freezing at -86 °C (-123 °F) through its durable design, minimizing product loss due to package failure.

FOCUS ON CLINICAL TRIALS

CRI's Response To NIH Cuts With Alicia Zhou, Ph.D.

In this episode of Cell & Gene: The Podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research.

The Flexibility Of Reconsent In Clinical Trials

Explore the common misconceptions surrounding reconsent, as well as the reality of its ability to be a flexible, ethics-driven communication practice grounded in respect for participant autonomy.

Who's In Charge? How To Ensure Effective Trial Oversight And Leadership

Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

Simple Description Of Clinical Analytics

Without teamwork, the best solutions still fall short. Unlock your clinical data's potential and transform chaos into clarity by starting with clear questions, adapting to insights, and fostering collaboration.

The Hidden Healthcare Benefits That Home Trial Support Provides

Examine how Home Trial Support (HTS) enhances both patient and caregiver safety and well-being, while alleviating pressures on sites and generating greater ROI for sponsors.

The Path From Big Biopharma To Leading In The Biotech Industry

Jerry McLaughlin, CEO and Board Member at Life Biosciences, explores the current biotech playground and the importance of wearing multiple hats in finding the right team.

Advancing Neuroscience Research With Data-Driven Innovations And AI

Learn how to employ data-driven insights, artificial intelligence, and decentralized clinical trials to accelerate drug development and address the intricate challenges of neuroscience research.

CLINICAL TRIALS SOLUTIONS

Meeting Eye Exam Needs At The Point Of Need - 20/20 Onsite

Full Service CRO And Regulatory Partner For Biologics - Veristat, Inc.

Reframing Clinical Vendor Selection - ClinAI

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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