BioLife Solutions, Inc.

In a new Pharmaceutical Executive Magazine article, BioLife’s Chief Technology Officer, Dr. Sean Werner, states that many promising cell and gene therapies do not fail because of safety or clinical efficacy problems, but because of manufacturing, quality-control, and regulatory issues that emerge late in development.

Dr. Werner explores how CGT developers often focus heavily on clinical success, while underestimating the importance of Chemistry, Manufacturing, and Controls (CMC), assay validation, and process consistency. By the time these issues surface during an FDA review, fixing them can be costly and time-consuming. 🕜

Dr. Werner offers solutions to three common reasons a therapy may be delayed or rejected during regulatory review. 💡

➡️ Read on or listen to an audio transcription here: https://www.pharmexec.com/view/why-breakthrough-cell-gene-therapies-fail-finish-line

Congratulations to Dr. Jason Acker of PanTHERA CryoSolutions Inc., part of BioLife Solutions, on his acceptance of being a new Scientific Board Member at NSF ERC Advanced Technologies for the Preservation of Biological Systems (NSF ATP-Bio). 👏

ATP-Bio’s goals are to significantly expand the capacity to preserve and transport cells, tissues, organs, etc. through a collaborative effort focused on developing innovative and modern biopreservation technologies.

Dr. Acker is looking forward to applying his expertise in cryopreservation, stem cells, bioinformatics, and hematology to benefit various pioneering studies and programs at ATP-Bio.

Image Credit: ATP-Bio; Convergent research approach at ATP-Bio.

In a recent episode of the Molecule to Market podcast, host Raman Sehgal spoke with Sean Werner, our Chief Technology Officer, on cell and gene therapy innovations and where the industry is heading. 🎙️

Two highlights include:
❄️ The essential role of cryopreservation, and why it remains a missed risk in R&D for advanced therapies.

⚗️ How the CGT industry is positioned to spread into more specialized areas, creating new therapeutic applications.

Learn more about this episode: https://ow.ly/RPmo50YXOHP

🎧 Ways to Listen:
Apple: https://ow.ly/ws9x50YXOHQ
Spotify: https://ow.ly/IVqy50YXOHO
Amazon: https://ow.ly/3uX050YXOHN