Newsletter | November 19, 2019

11.19.19 -- Are Allogeneic MSCs Ready For Primetime?

 

Hello Cell & Gene readers,

 

Preclinical data suggests that allogeneic mesenchymal stem cells (MSCs) do not elicit robust immune responses in vivo, which may make them candidates for broadly applied therapeutic applications. In his insightful article, Dr. Bruce Bunnell, director of the Tulane Center for Stem Cell Research and Regenerative Medicine, professor in the Department of Pharmacology, Tulane University School of Medicine, and Cell & Gene editorial advisory board member, details whether allogeneic MSCs are ready for primetime.

 

Considerable effort has been expended by both the sponsor and CDMO throughout the selection process. This article explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting.

 

Erin Harris, editor in chief
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Industry Insights
Jumpstart Cell And Gene Therapy Commercialization With SUT Learning
Article | By Derek Pendlebury, CPC

Single-use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. 

How To Adapt Your Existing Biomanufacturing Process To Maximize Production
Article | By Patrick Guertin and Yasser Kehail, GE Healthcare Life Sciences

Achieving “smarter,” more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.

Cell Therapy: Process Design Considerations To Support Commercialization
Article | By Herman Bozenhardt, Bozenhardt Consulting Services, and Erich Bozenhardt, IPS-Integrated Project Services

Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?
Article | CCRM

In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by their end use. This blog outlines the challenges for optimization of scaled-up LV manufacturing processes and new technologies being used to solve these challenges.

Rapid Sterility Testing: Viral And Gene Therapy Applications
White Paper | MilliporeSigma Cell and Gene

For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.

Quantifying Viruses? Here’s What Matters Most
Q&A | Sartorius Cell and Gene Therapy Manufacturing Solutions

With viruses playing a greater role in everything from vaccine development to gene therapy, ensuring their rapid, accurate, and biologically relevant enumeration isn’t just an analytical “plus;” it’s the first step in the development of biological tools that support human health.

Solutions
PAS-X MES Software For Cell/Gene
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Droplet Digital PCR Systems
Bio-Rad Laboratories, Inc.
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