Newsletter | January 14, 2020

01.14.20 -- Why Digital Networks Are Needed To Support Cell And Gene Therapies

 

Greetings Cell & Gene readers,

 

A key enabler for personalized therapies is a community-based supply chain supported by a responsive digital network. This article is a call to action for practitioners and providers of services for digital networks, technologies, and applications.

 

Here are the four steps the cell and gene sector needs to take now to ensure it has the capabilities to deliver transformational therapies in the future.

 

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, IPS-Integrated Project Services

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.

Purification Of Antibodies With Hydrophobic Anion Exchange Resin
Application Note | By Xuemei He, Louisa Vang, Mark Syder, Payal Khandelwal, and Daniel Yoshikawa, Bio-Rad Laboratories, Inc.

A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.

Downstream Process Intensification Of Virus Purification Using Single-Use Membrane Chromatography
Case Study | By Ranjeet Patil and Mochao Zhao, MilliporeSigma Cell and Gene

The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time-to-market. This article presents several case studies highlighting the advantages of process intensification using Natrix single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.

Closed And Semiautomated Processing Of CAR T Cells
Application Note | GE Healthcare Life Sciences

Challenges of T-cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T-cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

What Is The Cost Of Not Doing MES?
White Paper | Werum IT Solutions America, Inc.

In this age of digitization, many pharma and biotech companies still struggle to gain senior level buy-in for investments in manufacturing IT. This white paper covers major saving areas with MES as well as typical steps to evaluate ROI.

Solutions
Cell And Gene Therapy Manufacturing Solutions
Sartorius Cell and Gene Therapy Manufacturing Solutions
Genderless AseptiQuik L Series Connectors
CPC
An Introduction To The Sefia Cell Processing System
GE Healthcare Life Sciences
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