Cell-based drugs drive cryo-freeze tech over ‘home-brewed cocktails’

This week Parcell Laboratories announced it had adopted a cell- and tissue-freezing technology made by BioLife Solutions for use in clinical trials of adult stem cell (ASC) therapies. BioLife’s CryoStor reagent protects fragile cell therapies, cells and tissue samples from trials against damage caused by the freezing and thawing processes required during transport.

Parcell’s Chief Scientific Officer told the Global Technology Community Cell & Gene Therapy Conference last week that the company had already used the reagent to transport a novel type of ASC, known as Early Lineage Adult (ELA) stem cells.

These ELA cells had been used successfully in 3,500 surgical spinal fusion procedures, and Parcell believed “ELA cells likely represent a novel source of stem cells for the potential treatment of numerous [other] diseases​,” and would continue using BioLife’s agent in future trials, said Colin White.

‘Home-brew’ labs​

CryoStor is made with dimethyl sulfoxide (DMSO), a permeant solute cryoprotective agent which helps prevent damage caused by intracellular ice. Cryopreservation temperatures can span -80˚ to -196˚C.

BioLife claims the technology is better at preventing necrosis and apoptosis in the preservation process than commercial and “home-brew” extracellular formulations.

“Our top competitor is not another commercially available media, it is home-brewed cocktails,​” Daphne Taylor, Chief Financial Officer, told BioPharma-Reporter.com.

“These are created in a laboratory, using a traditional approach, which is not designed for today’s commercial clinical manufacturing requirements and regulatory scrutiny.​

“Our products address the current unmet need for very high quality, clinical-grade biopreservation media products used to store, ship, freeze, and administer cells and tissues to patients – by extending shelf life and enabling improved post-preservation viability (less cell death) and faster functional recovery (surviving cells resume their intended purpose sooner).​”

Taylor said BioLife’s technology was being used in more than 100 hospital-approved or clinical trials for regenerative medicines, by “commercial cell therapy and tissue engineering companies, hospital-based stem cell transplant centres, university-based research labs, umbilical cord blood banks, adult stem cell banks, tissue banks, biorepositories, hair transplantation centres, pharmaceutical companies, cell suppliers, and toxicity testing labs.​”

$23bn market​

Taylor said demand was growing for ways to store and transport materials for biotherapies stably.

“Recent advances in cord blood banking, adult stem cell banking, cell therapy, and tissue engineering have highlighted the significant and unmet need to maintain the stability and shelf life of biologics in the development and commercialization of new regenerative medicine products and therapies. ​

“Scarce and fragile source cells or tissues are extracted from a patient, transported to a cell processing and culture laboratory, and then transported back to the clinic for patient infusion or injection. Because this entire process can take months and may involve transportation over long distances, maintenance of cellular viability is of paramount importance.​”

This view was backed by Alexander Vos, CEO of Dutch regenerative and cell therapy CMO PharmaCell, who told BioPharma-Reporter.com the company used products from BioLife and other companies to stabilize cell freezing.

“What we tend to do is use products like this from BioLife Solutions because we find that their cells are coming out of that interim state being cooled or frozen in a better condition​,” he said.

He added the company was seeing a “clear ramp-up” in demand for cell-based therapy and regenerative medicine.

A recent market research report​ forecast the translational regenerative medicine market comprised of cell and gene therapies and tissue-engineered products grow to more than $23bn by 2024.