Newsletter | November 5, 2019

11.05.19 -- FDA FY2018 Human Tissue & Cell Therapy Observations, Trends

 
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The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of the cutting-edge presentations, from the sustainability of biosimilars, to the regulatory climate in Asia, to the challenges facing the international bioprocessing community and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:

Download the full e-book here: BioProcessing Asia Conference In Review

From The Editor

Greetings Cell & Gene readers,

 

A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA.

 

I recently had an informative conversation with Dr. Jiwen Zhang, VP, regulatory affairs at Philadelphia-based Passage Bio, to gain a better understanding of what industry professionals should do to meet the sector’s ever-evolving requirements. Here’s part one of our conversation.

 

Erin Harris, editor in chief
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Industry Insights
How To Speed Up Cell And Gene Therapy Treatments For Patients
White Paper | by Shawn Opatka, Werum IT Solutions America, Inc.

This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.

What Cell And Gene Companies Need To Know About Leasing Space
Article | By Herman F. Bozenhardt and Erich H. Bozenhardt, Integrated Project Services (IPS)

One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series we will explore what considerations companies need to make before they decide what type of property to pursue.

Translating Biopharma Knowledge To Cell And Gene Therapies
Article | By Catarina Flyborg, GE Healthcare Life Sciences

Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

Regulatory Oversight On Gene Therapy In The U.S. And EU
Article | Premier Research

Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

Solutions
Pharma Wall And Walkable Ceiling Cleanroom System
AES Clean Technology, Inc.
An Introduction To The VIA Thaw Dry Automated Thawer
GE Healthcare Life Sciences
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