"The global CRAMS scenario has been very competitive, complex and cyclical. We are dependent on the success of the molecule moving from research to process development and then preclinical development," says Dr Prabuddha Kundu, executive director, Premas Biotech. "Any product related or efficacy related issues of the molecule usually results in the dropping of the discovery program, which then has a domino effect on us, who are dependent on that molecule moving ahead. So, Premas has a robust pipeline of the possible projects that we are handling."

Established in 2005, the Manesar (Haryana) based Premas Biotech is a 100 percent Foreign Direct Investment (FDI) Contract Research And Manufacturing Services (CRAMS) organization. The uniqueness of the company within this vertical of research outsourcing is that it specializes in protein analysis and manufacturing. Over the period of time, the company has integrated thorough scientific analysis along with process know-how to accomplish its delivery of services to the customer.

Company with the difference

On being asked what makes them unique in the business, Dr Kundu says, "Delivery of services does not finish with the protein, but includes the Premas experience, that a customer undergoes which includes, customer engagement, project management, understanding customer goals and a keen eye constantly on product quality."

Giving an example, Dr Kundu goes on to add, "Premas has an internal protein expression analysis software, that is proprietary to us, and has been able to generate a lot of buzz amongst our customers. It is a very interesting scope enabling piece of analytical software. The software predicts the difficulty of the protein being expressed, issues related to structure-function, and species for expression. It is back-ended to our database of proteins delivered, and we have a high rate of prediction success. Earlier last year, a company based in East Coast, the US, challenged the prediction ability of the software, and gave us a number of sequences, whose result, they knew, and we were 100 percent correct in predicting which ones would be difficult and which ones would be easier on a relative scale. But I would be cautious in extending this logic to all proteins, but these are ways we have made the Premas experience for our customers a satisfying one."

Premas has worked with the Open Source Drug Discovery (OSDD) program of Council for Scientific and Industrial Research (CSIR) amongst others. The company has also aided in the food security program of Government of India, by delivering three proteins which were technically challenging. "Presently, we have research assignments with the Top 5 pharma companies of the world. We have delivered over 230 proteins, and this year alone, we have delivered close to 200 grams of cumulative purified protein delivery, which is a significant number. So, taking this into perspective, we are a niche protein research services company, very focussed, and customer oriented," reveals Dr Kundu.

Growth momentum gains pace

As per Dr Kundu, the company posted some impressive numbers over the past two years, growing steadily. However, he feels that for a niche company like his, the more important parameter of progress is how many large pharma customers he engages and how much preclinical material, he is able to ship out. In this two areas, we have done fairly well.

"I will not name my customers, but safe to say, we have 3 of the Top 10 global pharma companies working with us, we are developing rMAbs for another very large global pharma. In the Agbio arena, one of the largest companies are working with us and we have delivered about 130 grams of protein for toxicity and safety studies. So, overall, despite the recession, Premas over the past year has been able to engage global pharma companies with our focussed deliveries," he adds.

Entrepreneurial blues

Dr Kundu feels that the entrepreneurship is difficult and challenging in any sphere of work. Being a niche company in bioresearch is of course challenging enough, but this is the journey that he decided to undertake, and hence he says it is satisfying in itself.

Talking about the challenges, he says, "Some of the challenges that we face are fairly generic for any upcoming company such as recognition, acceptance in the market, meeting customer expectations, route to market, and new technologies to adapt. In the more specific areas, the challenges would be manpower availability, access to key-opinion leaders, biotech ecosystem, and access to risk funding. However, as we continue to grow, some of these challenges recede and others come up."

Good growth expected

According to Dr Kundu, Premas has invested deep into difficult to express protein platforms and know-how. This has had its positive effects on biobetters as well as biosimilars, though its primary focus is on enabling customers with their novel molecules. "We are now working on a few novel molecules, including one novel fab molecule for oncology application for a Europe-based customer. So, our focus is going to protein deliveries related to gene-preIND molecule expression, scale up, development of analytical methods, and delivery of sterile drug substances. Also, we have a parallel focus on agribiotech protein delivery systems. We have had fairly good success on some agbio proteins. As such, we cater to four application areas of drug discovery, agribio, animal health and reagent generation," he says.

Talking about the outlook of the sector, Dr Kundu says, "There has been significant growth in the CRAMS arena with a number of players entering the arena, however in the protein segments, it is still an area of high capital investments and difficult technical barriers. Once, access to funding and protein expression platforms are there, then we will see a number of players enter the protein segments as well. We do see double-digit growth over the next five years."