Enabling the creation of new products and technologies that meet industry needs

How the Cell and Gene Therapy Catapult worked with cryochain technology experts Asymptote to enhance their portfolio – delivering a unique and transformative technology that will enable the industrialisation of potentially life-saving therapies

Cell therapies are dramatically changing the healthcare landscape. They have the potential to offer innovative new treatments in some of the most challenging diseases, not least of which is cancer. But the process of bringing these therapies to realisation is complex, and requires sensitive handling to ensure the potency of the cells is maintained during manufacture, transportation and production.

In 2015, the Cell and Gene Therapy Catapult (CGT Catapult) began work on a collaborative project with the UK cryopreservation business Asymptote, with the goal of advancing the development of a novel point-of-care, dry thawing system for the delivery of cell-based therapy. When thawing cryopreserved cells using standard methods, such as laboratory water baths, the uncontrolled process introduces the risk of inconsistencies between patient treatments, alongside an inherent risk of contamination from the ‘bug infested’ water itself. This can result in poor performance in clinical trials, leading to false conclusions as to the efficacy and the commercial viability of a cell therapy. Working with CGT Catapult, Asymptote sought to offer a next-generation solution to this challenging problem.

As a result of the collaboration between CGT Catapult and Asymptote, a family of vial and bag thawers are being developed for use in laboratory and clinical trial research units. The CGT Catapult brought much needed additional resource including cell therapy expertise to the project while the engineering and design skills came from Asymptote. The devices optimise the thawing process and simplify the delivery of cell therapies at the point-of-care. Through the incorporation of Asymptote’s cloud-based solution for data collection, the devices can provide physicians and researchers a reliable log of the conditions a therapy has been exposed to during thawing. Having successfully proven the performance of the devices as a new, viable option for thawing cell therapies, Asymptote significantly increased its attractiveness to the healthcare market as an investible business.

By 2016, the CGT Catapult had licenced the intellectual property generated by this collaboration to Asymptote. As a result, Asymptote has been able to commercialise the thawers in the wider international cell therapy market, initially through a partnership with Cook Regentec.

Following these successes, in April 2017 the renowned global healthcare company GE Healthcare acquired the Asymptote business. At the time of the acquisition, GE Healthcare highlighted how the Asymptote suite of integrated cryochain hardware, software and consumables filled a critical gap in its end-to-end portfolio of products and services for cell therapy production. GE Healthcare also noted that this will be an important piece of the portfolio enabling the industrialisation of these potentially life-saving therapies.

The acquisition of Asymptote by GE Healthcare is a textbook example of how Catapult centres, such as the Cell and Gene Therapy Catapult, can help businesses commercialise their products.

Keith Thompson, Chief Executive Officer, CGT Catapult

The development of this thaw-in-clinic technology fills a crucial gap in the good manufacturing practice (GMP) logistical chain. The commercialisation of a cellular thawing system will bring advanced cell-based therapies closer to patient access. We have valued working in collaboration with the Cell and Gene Therapy Catapult over the last few years. Their support not only shaped the development of our range of thawers, ensuring they meet the needs of the cell therapy industry, but also their commercialization, through regulatory advice and product validation testing.

John Morris, CEO of Asymptote (part of GE Healthcare)

The first in a new range of cell therapy thawers, known as the VIA Thaw series, will now be manufactured, produced and sold by GE in the UK and distributed globally for use in laboratory and clinical trials.

GE continues to work with Cook Regentec to supply thawers compatible with the specific vials commerciliased by Cook Regentec. In addition, the first in the VIA Thaw series is now available from GE.