Stabilization Technologies Eliminate Cold Storage Need

Global pharmaceutical and biotech companies are showing heightened interest in stabilization and drug delivery platforms patented by UK pharmaceutical contract manufacturer Nova Laboratories Ltd. the company recently announced.

The company has developed two stabilization platforms aimed at entirely removing the need for cold storage, achieving faster dissolution and providing aseptic-grade pharmaceutical products. Both platforms are now commercially available following efficacy trials, and Nova claims they could revolutionize the delivery of therapeutics and diagnostics across the globe and significantly cut costs.

Nova Laboratories’ drug delivery device HydRIS has been developed to stabilize vaccines in a ready-to-inject format to remove the need for cold storage. It works by drying a mixture of active ingredients and a blend of amorphous, glassy sugars onto a filter paper-like membrane, which is then enclosed in a plastic casing. The casing has ports at either end for a needle and syringe, allowing liquid from the syringe to flood the device and instantly reconstitute the dried material before being injected directly into the patient.

The device has been tested with conventional vaccines, labile products, and highly sensitive live virus and bacterial vectors, which were kept stable for prolonged periods at elevated temperatures as high as 45°C without any product degradation. The device removes the requirement to refrigerate vaccines and as such has far-reaching applications in therapeutics, field medicine, bio-defence, and diagnostics.

The system has undergone a successful proof-of-concept study by scientists at Oxford University, whose results were published in Science Translational Medicine, and featured this March in BBC1’s scientific program Bang Goes the Theory.

Sam de Costa, Stabilization Project Manager for Nova Laboratories, said the technology has the potential to meet domestic and global healthcare challenges related to storage and stability

“A significant proportion of vaccines in the world are destroyed because of improper storage. We are trying to create solutions, which allow products to be stored at ambient temperatures wherever in the world they may be. Removing the need for refrigeration brings a number of key benefits – primarily in that it reduces the cost implications associated with cold storage. It also dramatically simplifies logistics, which could be crucial in the supply of vaccines to developing countries. As well as the benefits for human health, the device’s portability makes it ideal for veterinary surgeons where the need for flexibility and mobility is great.”

Nova Laboratories has made its VitRIS capability available to pharma and biotech companies after years of research to remove lyophilization from the manufacturing process. The technology produces a stabilized, soluble powder that can be instantly dissolved without the need for an additional reconstitution step.

Based on the well-established industrial spray-drying process, APIs are mixed with water-soluble glass formers and aseptically spray-dried as solid, non-crystalline glass – producing a highly polished microsphere in which the product is immobilized and stabilized. Powders can be instantly reconstituted into a ready-to-inject format by suspension in liquid – requiring the ability to match the density of the powder with the density of the liquid, to prevent the powder either floating or sinking. Nova has mastered this density balancing process and is now able to offer it as a service to clients.

In a further development to the technology, Nova now has the expertise to manufacture its patented Aerospheres, where a “blowing agent” is added during spray drying to create hollow spheres with a thin shell wall around the API. The thermo-stable Aerosphere dry powder can cut dissolution rates by a factor of 10 as compared to conventionally spray dried powder.

Trials have shown that the VitRIS technology can be successfully applied to a large number of pharmaceutical preparations including vaccines, insulin, monoclonal antibodies, recombinant growth hormones, proteins, enzymes and nucleic acids. As pioneers in aseptic spray drying, Nova is applying aseptic spray drying technology to manufacture thermo-stable powder for VitRIS and Aerosphere.

“VitRIS has a number of applications ranging from therapeutics to emergency medicine and bio-defence, and it can generate significant costs saving by removing the need for refrigeration. It has a high multi-valency potential and is compatible with vaccine adjuvants such as alum, which means it can play an important role in meeting modern healthcare requirements. These technologies are available now. We are engaged in numerous feasibility trials with existing clients, testing and improving our capability all the time,” said Mr. de Costa.

Nova Laboratories has developed a worldwide reputation for consistently being at the forefront of technological exploration and clinical standards. The company has MHRA-approved, state-of-the-art facilities at Wigston in Leicester, where it has developed world class expertise in aseptic processing of complex pharmaceuticals, using sterile isolation technology. Its core activity is manufacturing experimental medicines for some of the world’s biggest pharmaceutical companies and small biotech enterprises, who have spent years of research and development in creating them.The medicines then go on for clinical trials before being licensed for general use.

Nova was established – and is still owned – by ex-NHS professionals following a management buy-out in 1994. The majority of the original NHS team is still with the company, which now has 150 highly-qualified employees, and it retains a strong value for money ethos. Nova is investing heavily in ground-breaking technologies that ensure the highest possible standards of safe drugs manufacture, storage and transportation. For more information, visit www.novalabs.co.uk.