Public Funding for Biopharma Technology Limited

New vaccines are made from proteins that have to be injected using a needle. The process of making these proteins is very expensive and different for each vaccine. They cannot be put into tablets because they would be digested in the gut, and they need to be refrigerated and transported around developing countries via a distribution network called the cold chain. This project aims to create a way of making vaccines which is cheaper, requires only one manufacturing process regardless of the type of vaccine, and allows the vaccine to be swallowed as a capsule. These capsules will be designed to be stable without refrigeration for the few critical weeks needed for distribution between cities and remote villages, thus breaking the final link of the cold chain and allowing people to vaccinate themselves. We use a safe strain of Salmonella in the capsule, which produces the required vaccine inside the human body. The technology may revolutionise the way all protein vaccines are delivered and the first proof will be in the form of a vaccine against typhoid and bacterial diarrhoea, which cause hundreds of thousands of deaths annually.

This project aims to assess the commercial opportunity for a new laboratory consumable product. Specifically, Biopharma Technologies Limited (Biopharma) have submitted a patent application describing a reagent tube that enables freeze drying of liquid reagents directly in industry standard ‘eppendorf’ style reagent tubes. At present, temperature-sensitive and labile liquid reagents used in laboratory testing and experimentation are either shipped frozen in dry ice, which is costly and carries a very large carbon footprint, or they are freeze dried and sent at ambient temperature. The latter is more cost effective and significantly more environmentally friendly, but has been difficult to execute in the industry standard style of tubes. Where freeze drying is performed, alternative tubes like screw-caps or glass vials are used, but these are less acceptable by the end users. This project will assess the commercial opportunity that would be created by enabling freeze drying in ‘eppendorf’ tubes to be performed routinely, cheaply and cost effectively. This opportunity would arise from: • Converting existing liquid reagent products from liquid to freeze drying formulations • Allowing new products to be formulated for freeze drying without going through a liquid formulation stage • Extending the range of reagents to those that are unsuitable for a liquid formulation.

This project aims to develop novel bio insecticides from fusion proteins that deliver insecticidal toxins and across the target insect gut. The results of the project will be the creation of targeted fusion protein insecticides; this requires the development of processes for their economic production, acceleration of expression rate, and optimisation of associated fermenting and freeze drying. The detailed objectives are: (i) production of a "first candidate" fusion protein (ii) increase in expression and fermentation (iii) investigation of downstream processing and freeze drying (iv) delivery formulation for maximum efficacy and shelf stability (v) conduct all glasshouse/field trials to establish efficacy under end user conditions providing data for submission for registration, including effects on non target organisms (vi) application of these processes to streamline the development of follow up candidate fusion proteins

This project followed on from a previous TSB project that investigated the optimisation and stabilisation of probiotic material for incorporation into a capsule format. This project aims to build on this and develop a process to microencapsulate probiotic bacteria, allowing the delivery of a defined number of bacteria to the desired point of absorption, which is palatable to the consumer (e.g. less than 80 micron).The microencapsulation process developed must also stabilise the bacteria for long term storage as well as protect the microcapsule during ingestion and rehydration in the gut. In this project the partners involved have managed to (i) develop a capsule core (Bacteria/BAR) to hold and protect the bacteria during rehydration in the gut (ii) identify cost effective drying technologies based on bacteria survival and yield (iii) develop and apply enteric coating to protect the core (iv) demonstrate integrity of microcapsule to resist moisture ingress (v) demonstrate survival of bacteria against bile acid (control point of release) (vi) demonstrate long term stability (ambient supply), as well as producing process that can be scaled up.

The project aims to identify novel approaches to the processing and formulation of herbicides; that will enable enhanced bio-availability; this will allow lower application rates to be used without loss of efficacy. This will allow the same weed control action to be achieved with a lower rate of application, thus reducing overall environmental exposure. The project will focus on a small number of widely used herbicides to maximise the commercial and environmental gain. This project will have substantial spill-over benefits throughout the supply chain, with lower manufacturing and transportation costs, safer handling and reduced environmental impact. The project involves investigating new and current technology, studying processes used in other industries and bringing these skills to the agricultural industry. The project partners expect that the processes and principles identified in this project will be applicable to a number of other compounds.

Awaiting Public Summary