In light of the new pipeline of products, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has developed draft guidance. Today, that draft guidance is still pointing toward risk assessing certain aspects of manufacturing to get to a new paradigm.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