Manchester Science Park based Protein Technologies Ltd (PTL), a specialist fluorescent protein development company, has produced the world’s first ice crystal biosensor, CryoRed, which indicates whether damage to items such as vaccines or organs has taken place due to ice crystal formation.
In the cold chain supply networks, freeze sensitive labels and electronic time-temperature indicators are the norm. This is not a perfect solution as it is not the freezing event which causes damage to whatever is being transported, but the rate of freezing and the size of the ice crystals formed.
The slower the rate of freezing, the larger the size of the ice crystals and the greater the chance of product spoilage. Products could be vaccines, organs, antibodies or other biopharmaceutical items.
CryoRed is a fluorescent protein engineered to be hypersensitive to the formation of large ice crystals. It is a small dot that is usually bright red but when exposed to slow freezing conditions, in which large ice crystals are formed, it is irreversibly denatured and turns an opaque white.
Produced in small blister packs, it can be attached to individual products. It is cost effective because it is produced by fermentation and manufactured in bulk.
PTL has filed a comprehensive patent and is currently seeing licensees in the packaging and reagent industries, with a view to bringing the product to market within the next 8-12 months.
Chief scientific officer, Dr.Farid Khan, said: “In 2006, when a shipment of almost 20,000 flue vaccines was mistakenly frozen, Novartis elected to destroy the entire batch of 5000,000 doses rather than risk the chance of a single patient suffering an immunogenic response.
“CryoRed eliminates the needs for such huge waste. The versatility of formulation and low cost of manufacture means the potential applications are manifold and, as requirements for patient safety are becoming ever more stringent, we are ahead of the curve in pioneering individual product labelling.
“The ability to differentiate between different types of freezing events has not been possible before. Now, because of our product, it is.”