InstaDerm, a wound-healing treatment product developed at BITS by a team headed by Professor Aniruddha Roy of the Department of Pharmacy, is unique in that it can form an in-situ film at the wound site. In August, BITS Pilani signed a technology transfer contract for InstaDerm with Alicorn Private Limited, a biotech company interested in the commercialisation of the technology. 

PROFESSOR ROY’S RESEARCH

Professor Aniruddha Roy’s area of work is primarily polymer designing, biopolymer modification, and the applications of those polymers. Prior to InstaDerm, his team worked on developing a tumour-targeted drug delivery system. It then occurred to the team that wound-healing would be a relevant area to explore for the usage of modified biopolymers. The advantage of using a biopolymer scaffold in wound-healing is that it provides a basement membrane which acts as a mechanical support for new cells to attach to. Currently, products like biopolymer-mediated scaffolds are available in the market, but most of them have certain drawbacks.

PROBLEMS WITH PREFORMED SCAFFOLDS

All biopolymeric scaffolds available in the market are preformed and hence, structurally brittle. Thus, if one has a deep wound, the scaffold will be unable to reach the core area and will form a gap between the cells that they need to support.

Another problem is that the preformed scaffolds come in defined shapes like squares and rectangles which may not fit with the shape and size of the wound area. Since modifying the shape of a preformed scaffold is quite difficult and wound dimensions cannot be predicted, Professor Roy’s team decided to create an in-situ forming scaffold—one which would self-complex at the wound site. The team developed two kinds of polymer solutions, which when mixed, would complex almost instantaneously and make a scaffold at the site of injury.

PROCESS OF MAKING INSTADERM

While the exact techniques used are patent-protected, Prof. Roy provided a general overview of the mechanism. 

“What we developed is based on electrostatic interaction, where one polymer is positively charged and the other one is negatively charged. One polymer will make a complex—a very porous structure—and the second polymer will integrate the porous structure in a way that will give it mechanical strength by crosslinking it.” 

Cross-linking is generally done using chemical reagents, which are of varying toxicity and are not suitable for open wounds. Other disadvantages of chemical cross-linking include toxic by-product formation and insufficient stability. On the other hand, electrostatic crosslinking, as employed by InstaDerm, provides better stability. When the first polymer is applied and penetrates deep into the wound site, the other solution, which is oppositely charged, starts percolating into the already applied solution and cross-linking instantly. The opposite charges cause neutralisation which results in precipitation and water insolubility of the scaffolding. The polymers after cross-linking are no longer a liquid solution which can flow out from the wound area. This is the working principle behind the formation of a scaffold.

APPLICATIONS

The team is mainly focusing on burn wounds where intensive tissue damage has occurred, or chronic wounds which have consumed a large area of the tissue, such as a diabetic foot ulcer. Scaffolds have been quite effective in this type of wound healing. However, they are not suitable for sharp, narrow cuts as there is no extensive skin or tissue loss.

CONTRACT WITH ALICORN MEDICAL PRIVATE LIMITED

Prof. Aniruddha Roy and his team developed InstaDerm a long time ago. Since then, he had approached several pharmaceutical companies, but to no avail. Alicorn is a young start-up, hardly 5-6 years old, whose sole focus is wound healing. Prof. Roy found out about them through a Swiss friend who maintains an association with Alicorn. According to him, ‘The advantage of a new company is that they are agile and can take decisions very quickly’. In his experience, large companies showed interest, but took a long time to decide on investing as there was a lot of risk involved. On the other hand, smaller and newer start-up companies, such as Alicorn, were easier to approach, as the team was able to speak directly to top authorities and have them understand the required science.

The terms of the agreement outline how much support Alicorn will get from BITS in terms of the necessary know-how, the complete technology transfer, and the post-marketing revenue generation. BITS is currently working with Alicorn on making the product feasible for large scale production. The product is expected to be marketed in six months to one year.

PROBLEMS FACED AND COMMENTS ON RESEARCH

Regarding the scientific and technical aspects of InstaDerm, the process of development was fortunately very smooth, with the product giving positive results very early in development. Professor Roy’s only laments were in terms of the commercialisation of the product, saying that older pharmaceutical companies are often reluctant to invest in completely new ideas. He feels that nowadays, completely new research is not really encouraged in the pharmaceutical industry, with companies preferring small incremental changes to already existing products. This is understandable from a commercial point of view, as there is immense risk involved in investing in a completely new product. An advantage of approaching a start-up is that as a newer company, the start-up can invest in new equipment without needing to replace any pre-existing setup for the production of the product.

THE FUTURE OF THE PRODUCT

The demand for a product like InstaDerm is huge, as the wound-healing market is in the order of several billions around the world. In the preclinical animal trials, the product has shown remarkable efficiency. However, since animal systems (specifically the rat model that was tested) and human systems are so vastly different in terms of wound-healing, one still cannot comment on the actual efficiency of the product. Market analysis has shown that there is no other comparable product available at present, so if the results of the animal studies translate to human models to a good extent, then InstaDerm could have enormous potential.