Newsletter | January 7, 2020

01.07.20 -- 3 Keys To Realizing FDA's Vision For CAR-T And Other ATMPs

 

Greetings Cell & Gene readers,

 

USP held its 8th Bioassay workshop September 18 and 19 and expanded its scope to cover challenges related to potency assays for cell and gene therapy products. Here’s the detailed recap.

 

While much can be done to improve patient access through various social support and payer systems, the fundamental problem remains the time and cost of developing and manufacturing complex biopharmaceutical products, including CAR‑T-cell therapies. Learn the three keys to realizing the FDA's vision for CAR-T and other ATMPs.

 

Erin Harris, editor in chief
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Industry Insights
Single-Use Bioreactors For Platform Scalability
Application Note | By Michael Brown, MilliporeSigma Emerging Bio

Adoption of single-use bioreactor platforms across all scales, ranging from benchtop to production, are becoming increasingly popular due to their ease of use and operational flexibility.

Flow Cytometry-Based Exosome Detection And Analysis Using The ZE5 Cell Analyzer
Application Note | By Yasha Talaga, Elizabeth Dreskin, and Joyce Lee, Bio-Rad Laboratories, Inc.

Compare flow cytometry based exosome detection methods using the ZE5 and demonstrate that exosomes can be directly detected without being attached to beads.

Concentration And Reformulation Of Cellular Immunotherapies: A Major Downstream Processing Step
Article | CCRM

Cellular immunotherapies (e.g., CAR T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment cells are expanded in volumes from 1 L to 10 L.

Six Issues To Consider For Rare Disease Pre-IND Meetings
Article | Premier Research
Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. By proactively preparing for this meeting, sponsors can set themselves up for productive discussions, which may help in identifying areas of regulatory flexibility.
Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance
White Paper | GE Healthcare Life Sciences

As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, the ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies.

Extractables Testing On Single-Use Connectors
White Paper | CPC

Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.

Solutions
Integrated Vector Production Capabilities
MilliporeSigma Cell and Gene
Modular Cleanroom Panel Manufacturing Factory Tour
AES Clean Technology, Inc.
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