Newsletter | September 3, 2019

09.03.19 -- ICER's Value Assessment Framework For Curative Therapies

Reimagine workflows at CAR-TCR in Boston.

Speed and efficiency are critical elements of a biomanufacturing strategy, and the right supplier can contribute to your business success. Discover how automated solutions for cell and gene therapy can streamline operations from process development through manufacturing. Engage with GE to gain access to our industry expertise and insights that boost productivity, increase output, strengthen performance, and speed results. Register today to connect with one of our experts at CAR-TCR (Booth 28).

From The Editor

Greetings Cell & Gene readers,


According to some estimates, up to 60 cell and gene technologies could be available on the market by 2030. With such an influx of these new technologies expected, there is also trepidation about how payers will value these therapies and pay for them. What's a cure worth? ICER publishes the value assessment framework for curative therapies.


Data integrity is developed over the course of executing business operations rather than delivered as a solution after the fact. Your organizational design directly impacts the data integrity of the cell and gene therapies you develop and manufacture. Here’s what your organization design says about your commitment to data integrity.


Be sure to check out Cell & Gene’s Content Collections — a collection of original, insightful editorial on a specific topic impacting the cell and gene sector. The focus of our current Content Collection is Commercialization. We will update our Content Collection once a quarter, and you’ll hear from me when our newest collection is live.


Erin Harris, editor in chief
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Industry Insights
Bioprocess Facility Design: Layout Rules And Configurations
Article | By Herman Bozenhardt, Bozenhardt Consulting Services, and Erich Bozenhardt, IPS-Integrated Project Services

Expansions and renovations to existing biological facilities, and construction of new facilities, provides a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations
Case Study | AES Clean Technology, Inc.

A GMP manufacturing suite was developed from its inception by AES, which included a custom-designed and constructed clinical manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

Now And Next: Mavupharma
Q&A | Jubilant Biosys

Saurabh Kapure, vice president, business development, USA, for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and cofounder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares with Saurabh his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry.

Viral Vector Production Series
Video | GE Healthcare Life Sciences

In our tutorial series on viral vector production, GE scientists share their insights on virus production and how to tackle viral vector manufacturing challenges. In one episode a scalable production process for adenovirus is presented.

Webinar: Smarter Development Of Chromatography Processes

September 24, 2019 | 11:00 AM EDT

Smart process development is a collection of approaches to make process development better and faster — providing the developers with tools to face the rapidly changing landscape. This webinar will review three fields that enable reduced timelines and improved outcomes of process development activities:

  • In-silico process development and data-driven decisions
  • Management of process variability through deeper process understanding
  • Use of high-throughput methodologies
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