Newsletter | January 10, 2024

01.10.24 -- How To Minimize Bioburden On Gene Therapy Batch Yield

SPONSOR

Cell & Gene Live welcomes Dr. Peter Marks, director, CBER, FDA, and Dr. Nicole Verdun, super office director, CBER, FDA, to discuss the evolving regulatory landscape in 2024 for cell and gene therapies. Join this interactive discussion as we cover improved communication with sponsors, increased speed availability through manufacturing processes and standards development, and much more. Registration is free thanks to the support of Thermo Fisher Scientific.

FEATURED EDITORIAL

Minimizing Bioburden And Sterility Testing Impacts On Batch Yield

By BioPhorum

It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status. 

INDUSTRY INSIGHTS

The Future Is Now: CGTx Innovation, Challenges, And Perspectives

Webinar/Webcast | Precision ADVANCE

Industry experts discuss the latest healthcare advancements, their transformative impact on patient outcomes, and strategies for accelerating the delivery of these life-changing treatments.

To GMP Or Not To GMP? That Is The (Plasmid) Question

Article | By Eric Gudorf and Erika Morris, Ajinomoto Bio-Pharma Services

As critical raw materials for viral vector production, plasmids are in high demand. See how employing an experienced GMP-grade plasmid supplier for your process can mitigate risk and yield reliable results.

3 Factors In Prosperous Orphan Drug Development And Manufacturing

Article | AGC Biologics

To address the challenges associated with the creation of complex orphan drugs, learn how teams can improve process controls, identify global supply chains, and be flexible to scale with projects.

How Early Risk Mitigation Is Conserving Drug Product To Treat More Patients

Article | By Scott Sznyter and Tatiana Nanda, The Center for Breakthrough Medicines

The rigors of early process development in cell and gene therapy may appear burdensome, but prioritizing certain early studies can mean the difference between success and failure for these products.

Efficient Scale-Up Of Genetically Modified MSCs In Multiplate Bioreactors

Article | Minaris Regenerative Medicine

Explore the 2D scale-up of adherent cell cultures, guidance on achieving large-scale, and an optimized multiplate bioreactor process for the expansion of genetically modified mesenchymal stem cells.

SOLUTIONS

GMP Viral Vector Manufacturing

Genezen

A CDMO Focused On Accelerating The Path From Bench To Clinic

BioCentriq

Technologies That Smartly Scale iPSC To Benefit Human Health

Cellistic

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