SubscribeIf your business is involved in the distribution of cold chain products then you have probably heard of Kryotrans. This company based in the South East of England offers what it describes as the world's most secure and effective system for transporting temperature sensitive products.
Its main market is the pharmaceutical and biotechnology industries, but also any business, from chocolate manufacturers to Sushi exporters, that needs to transport valuable products that are highly sensitive to temperature changes, from -140°C through to 37°C.
The Kryotrans system was the brainchild of John Pring, the Company’s Technical Director. Whilst the Board member with responsibility for quality at the National Institute for Biological Standards and Control he became aware that many biological products that were sensitive to temperature change were arriving at his laboratory in a considerably degraded state due to them having reached temperatures outside of their desired range whilst in transit. He felt something had to done and so after two years work the Kryotrans system was born.
John’s hard work and novel approach to this very significant problem was rewarded with patents being granted to protect the unique attributes of this system. Indeed the Kryotrans product range is recognised as a state of the art solution in a marketplace that is experiencing rapid growth as regulation concerning the monitoring and maintenance of cold chain items is becoming increasingly rigorous.
The Company is headed by Chief Executive, Colin Rickson, a successful entrepreneur who has over twenty years experience in the cold chain industry. The core management team is completed by Sean Flanagan, Finance and Commercial Director. Rickson says, “Between us we have the unique combination of medical, technical, electronics and commercial expertise that allows us to really understand and help solve our customers problems”.
Pring adds “changes to regulations are presenting our customers with significant new challenges as to how they ship their products and we are confident that our system will meet the most stringent of requirements”.
The value of sensitive medical materials shipped yearly is estimated at £340 billion, comprising pharmaceutical and biotechnology products and samples, clinical trials materials, blood and vetinary products. Consider this with industry estimates that between 5 per cent and 9 per cent of these products suffer from significant depletion in potency while in transit (the World Health Organisation suggests a figure of 50 per cent for vaccines) and one can understand why Kryotrans can see a bright future ahead.
The Company’s relationship with logistics organisations is clearly important and it is in the process of building strong alliances with a number of major operators. The key benefit that Kryotrans offers to a logistics business is a solution to a growing customer need and the benefit that the logistics operator can provide is the management of an inventory of containers that will allow for the most cost and time efficient shipping of a customer’s goods.
The Kryotrans container is different from anything else on the market. Firstly unlike most of the competition it is reusable; being made of polyethylene with polyurethane insulation it is rugged and will easily withstand the rigours of long international journeys involving a variety of modes of transport.
The version pictured is the 70-litre container set for maintaining temperatures of between 2°C to 8°C and is largely used for the transit of vaccine products. The range of products extends from single product smaller containers to the largest 420-litre euro pallet size.
Its reusability allows the container to have an integral data logger incorporated. According to the Company this unique and important feature allows for greater integrity of the temperature information that forms part of the audit trail required by regulators than loose loggers used in disposable transit packaging products can provide. In addition the Kryotrans logger monitors both the external and internal temperature and access.
Colin Rickson believes that simplicity is one of the keys to success and says that the fact that it is a passive system with no cooling engines and a simple packing protocol is one of the benefits that most appeals to customers; “keep it simple wherever possible” he exclaims.
A major feather in the Company’s cap was the award of a 2 million Euro grant earlier this year to develop the next generation of intelligent containers with upgraded logging capabilities and insulation properties.
Kryotrans is also pleased to have signed a distribution alliance for the North American market with Lydall, the US supplier of bioprocess flexible containers.
The ability of the containers to maintain the temperature of its contents in all conditions has led to sales that span the globe and include evolving biotechnology companies through to the world’s pharmaceutical giants. The market opportunity is huge according to Sean Flanagan who adds “it is great to be a British company that has a world beating product with export markets representing over two thirds of our business”.
Why is cold chain distribution a current issue?
Industry changes are increasing the significance of cold chain management. Society itself has changed. People want to ask questions and get answers they understand.
Importance of proof / documentation / audit trail is paramount.
Regulation – increasing level of FDA, EMEA and MCA approval and enforcement activities
Public Awareness – Image and litigation concerns affecting share price and financial results are more prevalent
Products – Increased use of temperature sensitive product such as monoclonal antibodies, DNA, cell and tissue based products and increasing gene and protein based product development
Manufacturing – Need for specialised bio processing operations leading to increased outsourcing and focussed production
Distribution – Globalisation, regulation and increased product volumes and values are driving reviews of previously accepted logistics limitations
Technology – New insulation and quality / information systems capabilities now available at realistic prices
Cold Chain “attributable” failures result in:
- Litigation
- Product withdrawals
- Delays in clinical trials and product slower to market
- Lost contracts
- Recalls and associated costs
- Wastage
- Damage to Reputation
- Stock Price
- Sales
- Margins
Quality and Safety
A new generation of products designed to help pharma companies and their logistics providers comply with regulations are arriving in the market. One such product, the Kryotrans Cool Container won a 2002 Medical Design Excellence Award (MDEA) in the Finished Packaging category.
As Donald Barcan, one of the judges said “One of the novel features of this product is the ability to replenish the amount of CO2 without opening the contents of the package, which is different than what’s out there today…what’s out there today is variations of containers that use foam, but they use gel packs and other means of refrigerant. Usually, they’re packed around the product inside the container so replenishing them is not considered part of the operation”.
The containers also feature data loggers that are an integral part of the container; rather than standalone data loggers, which require administration and the associated documentation to match up batch identity for individual shipments. Integral data loggers also allow each container to have a unique identity. A complete audit trail matching the individual product with the temperature record of the transportation is now achievable with minimal human intervention.
With many logistics providers now offering specialised solutions to clients in the healthcare industry, such as clinical trials supply management and quality assurance testing, the ability to offer value added services is viewed as a major advantage in an increasingly competitive market. Satellite and telephony tracking capabilities offer real time information and tracking of shipments. Shipments are still prone to delays in Customs; the time is fast approaching when smart containers will alert the sender via their mobile and signal them to take appropriate action. When that happens, distributors will find themselves in the curious position of having their own shipments track them down and request action.
Setting up and establishing the Company has been a “rollercoaster ride” says John Pring, “but with the knowledge that we have the product to address the needs of a highly regulated marketplace we have stuck with it and we are now beginning to see the fruits of our labour”. What next for this entrepreneurial British business; “well we have only just started and our focus now is to build on our network of alliance partners and of course increase sales in what is truly a vast potential market” says Pring with an enthusiastic smile.