Bothell-based BioLife Solutions, Inc. has announced that UK-based TC Biopharm Ltd, a developer of anti-cancer immunotherapies, has incorporated the company’s CryoStor clinical and commercial grade freeze media in its manufacturing and clinical delivery processes of ImmuniCell, a novel T cell based immunotherapy targeting various cancers.
BioLife is the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers.
TC Biopharm has recently been granted a Clinical Trial Authorisation (CTA) by UK regulators to treat cancer patients with ImmuniCell. In designing the adaptive phase II/III clinical trial, TCB worked closely with the MHRA, through its Protocol Advice service, to establish a pragmatic treatment framework, which focuses on patient safety whilst maximizing the potential for an efficacious outcome.
The ground-breaking clinical trial design allows patients with melanoma, kidney and lung cancer to be treated in a single study – maximizing the potential to establish how three different cancer types respond to TCB’s innovative immunotherapeutic approach.
“We are very pleased to support this groundbreaking clinical trial and congratulate Dr. Leek and the entire team at TC Biopharm on gaining authorization to commence this trial,” said BioLife’s President and CEO Mike Rice. “This product adoption further demonstrates the demand and preference for our commercial grade biopreservation media products, which have now been incorporated into more than 200 pre-clinical validation projects and clinical trials of new cell-based products and therapies.”
In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030. Pharmaceutical Commerce estimates that in 2014, $8.4 billion was spent on cold chain logistics of pharmaceuticals, with $5.6 billion for transportation and $2.8 billion for specialized packaging and instrumentation. BioLife’s addressable market is comprised of the demand for small payload shipping containers and related temperature monitoring and location tracking devices.
