Newsletter | August 6, 2019

08.06.19 -- How To Manage An HCP Network For Cell & Gene Therapies


Greetings Cell & Gene readers,


When it comes to gene therapy, managing manufacturing capacity is challenging. Might it make sense for CMO/CDMOs to pool their resources rather than each building their own gene therapy manufacturing capacity


Cell and gene therapy manufacturers looking for potential HCP network partners often have diverse priorities when selecting clinical trial sites and later converting them to commercial treatment centers. Part three of this series addresses the primary requirements for the manufacturers' site preparation strategies.


Erin Harris, editor in chief
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Industry Insights
Biocontainment: An Introduction To Control Levels And Practical Design Concepts
Article | By Herman F. Bozenhardt and Erich H. Bozenhardt, Integrated Project Services (IPS)

In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA- or EU-regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.

How A New Cell Therapy Platform Helps Scale Up Manufacturing To Reach More Patients
Article | GE Healthcare Life Sciences

Cell therapy manufacturing has been a complex, challenging, and costly process, but a new manufacturing solution seeks to change that.

10 Tips For Western Blot Detection Of Phosphorylation Events
Article | Bio-Rad Laboratories, Inc.

The ability to interrogate protein phosphorylation events and aberrant phosphorylation levels is critical to our understanding of various biological and pathological processes, particularly in the research of diseases, such as cancer. However, detection of phosphorylated proteins in western blots can be challenging. Following are ten tips to ensure robust data generation and cleaner blots.


Revolutionize your cell, gene and CAR-T clinical and late stage programs by attending this year’s Cell & Gene Therapy Bioprocessing & Commercialization meeting, held September 9-12, 2019 in Boston. Register your team today to learn and network with 400+ of the brightest minds working in cell & gene therapies. Book online with code CELLGENE by August 30 to save an extra 10% (new registrations only). To view the full agenda and to register, visit here.

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