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Frost & Sullivan Applauds Asymptote’s Efforts toward the Development of a Liquid Nitrogen-free, End-to-End Cold Chain Solution

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March 25, 2014

Based on its recent analysis of the cryopreservation industry, Frost & Sullivan recognizes Asymptote Limited (Asymptote) with the 2014 European Frost & Sullivan Award for Technology Innovation Leadership. Asymptote’s commitment to providing novel, effective and environmental-friendly cryopreservation solutions is evident from its efforts to produce a liquid nitrogen-free, good manufacturing practices (cGMP)-compliant cold chain comprising end-to-end cryopreservation, shipping, and thawing of materials.

“Asymptote’s portable, self-charging, cryogenic solutions aim to improve the storage of live vaccines in developing nations. It has excelled in developing ultra-low-temperature storage equipment that helps to prevent the discarding of vaccines due to thermal stabilisation problems,” said Frost & Sullivan Senior Research Analyst Cecilia Van Cauwenberghe. “The company, which is innovatively using electrically powered Stirling cryocoolers in cryopreservation equipment, expects to significantly improve the distribution of live vaccines in territories where liquid nitrogen is not readily available and the supply of electricity is unreliable.”

Asymptote’s current low-volume liquid nitrogen-free cryocooler, the EF600-controlled rate freezer, consists of a low-cost, ultra-portable cryocooler, specifically designed for the cryopreservation of stem cells, embryos, and spermatozoa. It demonstrates a high level of cooling rate control accuracy, while simultaneously being simple and easy to handle. It supports numerous sample formats and enables the lab technician to work with linear as well as non-linear cooling profiles.

As EF600s do not require liquid nitrogen, the running costs are estimated to be one per cent of that of liquid nitrogen-controlled rate freezing. By not using liquid nitrogen and its detrimental effects on sterility, particulate generation, and oxygen depletion, the solution is ideal for use in Grade B clean rooms and can be adapted for use in operating rooms for the optimised cryopreservation of source material for autologous treatments.

The new VIA Freeze™ range of controlled rate freezers are designed to be very easy to use with a touch screen interface and remote access (with 21 CRF 11 compliance) can be used with the SBS plate standards from 1-4 plates. This allows users to easily program and upload cooling profiles for further validation and report generation. Furthermore designed to minimise temperature gradients, the VIA Freeze™ achieves precision control of the cooling rate and the temperature. The systems can also be adapted to be used with bespoke systems and automation if required.  Since Asymptote’s cryogenic solutions (controlled rate freezers and long term storage solutions) do not use liquid nitrogen they do not require the liquid nitrogen infrastructure and the associated health and safety systems required by other systems or the ongoing liquid nitrogen running costs and possibilities of contamination from liquid nitrogen.

The VIA Freeze™ enables the cryopreservation of cells in different formats such as cryovials, cryobags and cassettes. With a capacity of 250 cryovials, the VIA Freeze™ represents the best option for the creation of seed cell banks (SCBs) and master cell banks (MCBs), which require validated, reproducible, and safe methods of freezing cells during their creation.

Asymptote has also developed a novel active nucleation biocompatible material named ‘IceStart™’ that helps to reduce the damage caused by supercooling during the cryopreservation process. Compared to other products in the market, IceStart™ induces ice nucleation closer to the freezing point of the solution. This results in an important reduction in the number of samples that are subjected to extreme undercooling. Consequently the viability of the cells is substantially increased.

Asymptote’s research in cryopreservation is based on five principal projects – the development of a GMP cryogenic cold chain for the clinical delivery of regenerative medicine therapeutics; the development of coatings that induce ice nucleation; an improved method of freeze drying; the development of a portable, self-charging cryogenic vessel for the shipment and short-term storage of cryopreserved material; and the development and testing of technology for the cryopreservation of hepatocytes in microtiter plates for subsequent screening applications. These projects are carried out in collaboration with its customers, in order to continuously improve their results and ensure that their needs are met.

“The company is currently proposing the development of the first GMP-compliant cryogenic cold chain for the clinical delivery of regenerative medicine therapeutics. Asymptote is also developing an ice-nucleating coating for the inside of vessels that are used for cryopreservation, which will overcome the problems caused by random ice nucleation and improve cell recovery upon thawing,” noted Van Cauwenberghe. “The company expects to determine the real impact of these new developments in the market, as well as their disruptive influence on an existing solution or the creation of new products.”

Each year, Frost & Sullivan presents this award to the company that has demonstrated uniqueness in developing and leveraging new technologies, which significantly impacts both the functionality and the customer value of the new products and applications. The award lauds the high R&D spend towards innovation, its relevance to the industry and the positive impact on brand perception.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

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