Newsletter | February 20, 2024

02.20.24 -- 2024's Market Outlook For CGT

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Slow The Burn Part 2: A Deeper Dive On How To Mitigate Financial Risk Before Selecting An Outsourcing Vendor

Discover how to prepare for the financial responsibilities of clinical trials, understand the necessity for flexibility and creativity in a CRO contract, identify signs of contracts favoring the CRO's bottom line to the detriment of trial integrity, appreciate the role of AI in bid evaluation, and assert control over clinical studies by clearly outlining expectations.

FEATURED EDITORIAL

2024’s Market Outlook For Cell And Gene Therapies

RSM is back for the third consecutive year to provide an outlook analysis of the CGT market. This article discusses the state of the 2024 macroeconomy, its effects on CGT companies, growing approval pipelines, funding factors, and the unique prospects for the market.

Advice For Small And Emerging Biotechs

Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.

INDUSTRY INSIGHTS

The Future Of CGT: Expert Perspectives

Eight experts in the cell and gene therapy field explore regulatory expectations and guidelines around AAV gene therapy, tips for meeting regulatory guidelines, gene-modified cell therapy, and more.

Hemophilia - Global Clinical Trial Landscape

Delve into the clinical landscape of hemophilia, a rare X-linked congenital bleeding disorder, across three key regions of the globe, namely Asia Pacific, Europe, and North America.

Transforming T Cell Manufacturing Via Elutriation

This study demonstrates the Korus platform's ability to reduce manufacturing variability by elutriating lymphocytes from apheresis, providing a more consistent cell product for downstream manufacturing.

Optimize DNA Storage Using Dedicated Fluoropolymer Film

Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.

Automate Your Collection Of Lab Reference Ranges

Data managers invest a lot of time and attention in documenting lab processes. While necessary for ensuring validity and assessing safety and efficacy, this process is often inefficient and error prone.

How You Build Is As Important As What You Build

Modular cleanrooms are intricately engineered, durable, high-performance machines. Learn how these cleanrooms are compatible with your manufacturing process now and in the future.

New Container Protects Bulk Frozen Biopharmaceuticals

UUncover how a flexible freeze container can maintain package integrity after freezing at minus 86 °C (minus 123 °F) through its durable design, minimizing product loss due to package failure.

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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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Platelet Depletion And Enriching Mononuclear Cells For CAR T Cell Therapies

Optimizing And Scaling Lentiviral Vector Production

PEIpro Transfection Reagent

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