Newsletter | December 3, 2019

12.03.19 -- Sampling And Testing Of ATMPs


Hello Cell & Gene readers,


In light of the new pipeline of products, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has developed draft guidance. Today, that draft guidance is still pointing toward risk assessing certain aspects of manufacturing to get to a new paradigm. One of those aspects is sampling and testing.


When Joe Jimenez made the move from Big Pharma to small biotech he also learned about how quickly companies can move. The former Novartis CEO talks about how cell and gene therapies will drive innovation.


Erin Harris, editor in chief
Follow me on Twitter

Industry Insights
A Checklist For Engineering Due Diligence In Pharma M&As
Article | By Erich H. Bozenhardt and Herman F. Bozenhardt, IPS-Integrated Project Services

Pharmaceutical plants cannot be treated like real estate. Instead, they require a detailed assessment of where they are in “operational compliance and production readiness.”

Sorting Bone Marrow Mesenchymal Stem Cells With The S3 Cell Sorter
Application Note | By Xiaoti Guo, Ph.D., Bio-Rad Laboratories, Inc.

In this study, a S3 Cell Sorter was used to analyze and purify prospective mesenchymal stem cells (MSCs) from passage 1 (P1) and passage 3 (P3) bone marrow cultures. The data presented here shows the capability of the S3 Cell Sorter to isolate rare MSCs from a mixed bone marrow culture with satisfying sort efficiency and post-sort purity.

Mobius Single-Use Bioreactors: Platform Scalability
Application Note | By Michael Brown, MilliporeSigma Emerging Bio

Adoption of single-use bioreactor platforms across all scales, ranging from benchtop to production, is becoming increasingly popular due to their ease of use and operational flexibility. Knowledge of the performance characteristics at small scale allows predictable and easy scale-up across the platforms from 3 L to 2,000 L bioreactors. 

Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?
White Paper | GE Healthcare Life Sciences

Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.

Avoiding Costly And Time-Consuming Mistakes In Gene Therapy Process Development
White Paper | MilliporeSigma Cell and Gene

Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors, especially when development and manufacturing teams are operating with compressed timelines.

Ethical Considerations In Adaptive Design Clinical Trials
White Paper | Premier Research

While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. 

How To Scale-Up Lentiviral Vector Production Part 1: Considerations For Upstream Processing
Article | CCRM

Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. This blog explores the principles that govern the scaling of upstream processing (USP).

The 7 Essentials For A Successful Cleanroom RFP
Infographic | AES Clean Technology, Inc.

AES has over 30 years of experience soliciting and responding to cleanroom requests for proposals (RFPs). In that timeframe we’ve learned a thing or two about structuring a competitive RFP. If you follow these seven steps you will receive better responses and be able to identify differences and minimize risk.

Scaling Up For Commercial Manufacturing For Cell/Gene
Webinar | Werum IT Solutions America, Inc.

There are two new players on the biologics industry block: cell therapy and gene therapy. Join our featured speaker for a discussion of how cell and gene therapies differ from pharmaceuticals and learn about the challenges to achieving commercial manufacturing.

Connect With Cell & Gene: