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

Time is flying by! ⌛ We won the Biotech Innovation Award at INTERPHEX for our CellSeal® CryoCase rigid container exactly ONE month ago.

It was a proud moment to be recognized for our innovation and engineering work efforts. We’ve specifically designed the CellSeal CryoCase to mitigate common issues with cryobags in the advanced therapy space.

Challenges of cryobags that CryoCase addresses:

🆘 Fragility/Breakage
🆘 Unstackable
🆘 Awkward and time consuming to handle
🆘 Requires multiple operators
🆘 Difficult to inspect due to the translucent material composition
🆘 Contamination/particulates

Thank you to our loyal customers, the INTERPHEX staff & judges, and the BioLife team!

👉 Learn more about CryoCase: https://www.biolifesolutions.com/handling/cellseal-cryocase/

https://youtu.be/K6qVf1XfEjQ?si=h0yeBoT8POjn6oAi

Moving Beyond the Cryobag: A Closed-System Alternative for CGT Cell and gene therapies demand precision at every step — including storage and handling.In this video, BioLife Solutions compares traditional cryobags to the...

It’s that time of year…the 2026 Fred Hutch Obliteride 5K event is on!

Join us on August 8 in Seattle at the University of Washington. Many of our team members will be walking or running this 5K event.

If you haven’t heard, Obliteride is a fundraising event for cancer research, individual scientists, and programs at Fred Hutch Cancer Center. 🔬

If you participate, you can choose an area you would like your funds to go to – such as a specific disease area, program, clinician, or researcher. Learn more: https://www.obliteride.org/about/where-the-money-goes.html

We’re so proud to sponsor this event. If you would like to donate to BioLife’s team, please do so here: https://secure.fredhutch.org/site/TR?team_id=24460&pg=team&fr_id=2251

Thanks for your support. 🧡🙏

https://youtu.be/U5ipnPfiUak?si=2MKMYc6Hy_bxhXDw

Fred Hutch Obliteride 2026 Promo Fred Hutch Obliteride launches on April 9, 2026!Fred Hutch Oblite...

Can your choice of a particular storage container affect cell therapy outcomes? Yes, it can!

In a new interactive infographic with Cell & Gene Therapy Insights, we explore five different ways that container packaging can affect your product quality, regulatory reviews, and commercial readiness.💡

You will discover how packaging:
💥 Influences post-thaw cell viability and the reliability of QC data

💥 Maintains a closed process throughout fill/finish and QC sampling

💥 Enables manufacturability, scalability, and long-term commercial supply

View the infographic here: https://www.insights.bio/cell-and-gene-therapy-insights/journal/article/3797/5-ways-packaging-impacts-cell-therapy-outcomes

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

BioLife Solutions Reports First Quarter 2026 Financial Results

Total revenue of $27.5 million, up 25% over Q1 2025

Join the webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=JUSBp9Pa

Press Release: https://investors.biolifesolutions.com/2026-05-07-BioLife-Solutions-Reports-First-Quarter-2026-Financial-Results

Get ready for the next G-Rex Grant Tour Stop in Boston, MA on Monday, May 11! 🦞☕

If you are attending the American Society of Gene & Cell Therapy Annual Meeting, come by the Artists for Humanity building after the show from 3:00-9:00pm.

Vicky Tran and Monica Wight Wight will be onsite at the BioLife table. We can’t wait to hear from the keynote patient-speaker and Sickle Cell Disease warrior, Victoria Gray, and from experts on the latest ex vivo CGT developments and manufacturing.

➡️ Register soon: https://www.scaleready.com/initiatives/g-rex-grant-tour-2026/g-rex-grant-tour-boston-ma