Experts in biological sample, and medicinal product, storage and logistics management, CRYONISS offers a comprehensive storage service from ambient down to vapour phase liquid nitrogen.
The Cheshire-based team has a wealth of experience in supporting drug discovery projects, from early stage target identification through to clinical trials and life cycle management.
Now Cryoniss has won MHRA approval, the gold mark that confirms its ability to accompany clients on the whole journey from research to commercialisation and beyond.
Chief Executive Sonia Houghton said: “From pre-clinical to clinical sample storage and now actual medicinal drug storage, we can partner with them throughout the life-cycle of a procedure – and that is exactly where we wanted to position ourselves.”
The hard-won quality mark was awarded after the final round in which Sonia in particular was examined by the Medicines and Healthcare products Regulatory Agency on every aspect of the business, from her own personal knowledge of the regulations to the quality management and emergency back-up systems in place. The interview took four hours.
Over the course of the previous three months, Cryoniss also submitted the 170 or so documents required to demonstrate thorough quality assurance. However, thanks to the hard work of the Cryoniss team and particularly QA Consultant Anna Kozaczek, Cryoniss passed with flying colours.
With confirmation its facilities and business continuity management system are perfectly aligned with vaccine storage regulations, the company is ready to step into that particular breach.
It is capable of storing any vaccine at any temperature required, including an ultra-low temperature product such as Pfizer-BioNTech’s Covid jab at the headline-grabbing minus 70 degrees.
Business Development Manager Olivia Turner, who is the final weeks of a biomedical science degree and has a special interest in vaccines, said: “Our role will be to support the cold chain, the route of delivery from manufacturer to patient. Often that is literally a chain of freezers, used to store vaccines at the correct temperature so they don’t degrade and lose efficacy.
“At the minute, Covid vaccines are being transferred directly to clinics to meet current demand, but eventually they will be transferred to clinical storage hubs such as ours to hold until they are needed.”
When vaccines were stored it was in their undiluted form, she added. It was only when the stock was delivered to a clinic, thawed and diluted, that the clock started to tick on the shelf life of a vaccine.
Each vaccine had a different storage requirement and a different shelf-life. “The AstraZeneca Covid vaccine only needs to be stored at between two and eight degrees, which massively reduces both the complexity of the cold chain required and any mistakes that could be made,” said Olivia.
“It is much more difficult to maintain the ultra-low temperatures such as minus 70 and some countries might not be able to afford the number of freezers and level of transport needed to store and distribute, say, the Pfizer vaccine.
“At our end of things, we need to be aware of the logistical challenges as we send the vaccines on.”
Sonia Houghton herself is not only an experienced research scientist, but while working for AstraZeneca, she also established and managed a first class internal service providing next day delivery of qualified cell lines to its scientists – wherever they were based.
By the time she launched Cryoniss, in early 2019, she was an expert in providing contract services to research, pharmaceutical and biotech enterprises all over the world.
Cryoniss now has two storage facilities – one at Alderley Park and the other on Runcorn’s Heath Business and Technical Park – that between them can hold more than a million samples, from room temperature down to vapour phase liquid nitrogen (minus 196°C).
And it has the strategic capability necessary to distribute cell lines and vaccines alike. Sonia said: “Logistics is end-to-end cold chain storage and that is a major part of what we do. Due to Brexit, there is suddenly a huge demand for our services – our contract numbers are going through the roof!
“A lot of companies are struggling to cope with the changes now that we are subject to Third Party regulations, particularly if their researchers use animal by-products, which causes many more issues getting the product into the EU.
“But my team and I have long experience in importing and exporting all over the world, so we are well used to overcoming the hurdles presented by Third Party status.”
The team has worked hard to turn Cryoniss into a one-stop shop capable not only of storing investigative and medicinal products, but of sending them onwards, too, in a safe, tracked and traced manner.
Because every single aspect of what they do can be tailored to meet specific requirements, the team can also be invited into a trial or procedure relatively late in the day, for example when they are supporting the work of a laboratory offering a toxicology testing service.
Whatever the scenario, Cryoniss is ready to respond at any point throughout the lifecycle of a research project and, now, the distribution of a vaccine. “Research to commercialisation and beyond,” said Sonia.