THE BIOTECH ENTREPRENEUR

Dr Ravindra M Sapkota  

Executive Chairman and Scientific Director

Shikhar Biotech

Set to make a mark in the global biotech landscape

After having obtained a Master’s degree in Biochemistry from Oxford University in 1997, Dr Ravindra M Sapkota, Executive Chairman and Scientific Director of Shikhar Biotech, returned to Nepal to co-found his company in 1999 with a colleague. Prior to that, he held a teaching position at a medical college. “However, I always desired to pursue entrepreneurship and contribute to scientific progress in Nepal,” he says, adding that it has been a rewarding journey, leading Shikhar Biotech 
for the past 24 years.

Shikhar Biotech, originally named Everest Biotech, was established in response to a critical need in the scientific research community. Back then, researchers in Nepal lacked access to readily available antibodies. “We envisioned producing high-quality antibodies here in Nepal to be used by scientists worldwide for studying various diseases,” Dr Sapkota says adding that it is important to note that the antibodies that Shikhar Biotech produces are for research purposes and not for treatment. “We have a particular focus on research related to diseases with limited treatment options, such as cancer and Alzheimer’s disease,” he states.

In the current times, the biotechnology industry is showing high potential spearheading scientific innovation. 2024 is poised as a year that will unfold a diverse range of biotech companies that will break new ground to tackle global challenges. This is a field where science marries business, and post Covid 19, investment in the biotech industry is seeing a definite incline. But it’s not without its challenges, as finding success in this business requires a different kind of resilience and razor sharp focus.

What is heartening is that Nepal is in the race with the likes of Dr Ravindra M Sapkota who believe they will make a significant mark in the global biotech landscape with their efforts. 

In this edition of Business 360, Dr Sapkota, founder of Nepal’s first antibody company in Nepal, speaks about his venture and the future of biotech in Nepal. Excerpts:

Instead of getting into academia, why did you choose to open your own company?

In the late 1990s, the academic sector in Nepal offered limited opportunities for research due to restricted funding. There were also more research opportunities abroad. However, my passion was to contribute to scientific advancement in Nepal. My heart belonged here. Even during my studies abroad, returning home always filled me with excitement. The limitations in academia made pursuing entrepreneurship a more attractive path for me.

In which areas can your produced antibodies be found?

Initially, we set out to develop around 7,000 to 8,000 antibodies targeting various proteins. Currently, 3,000 to 4,000 of our antibodies are available in the market. It is important to emphasise that all our antibodies are used for research on various diseases and conditions, not for treatment itself. While we do not target specific diseases, we do focus on areas with significant unmet medical needs, such as cancer, Alzheimer’s disease and neurological disorders.

How is the research and development (R&D) situation in Nepal?

Nepal’s R&D environment faces challenges related to resource limitations. Opening a new business, particularly in the biotech sector, involves a lengthy process of obtaining government approvals. There is a heavy emphasis on clearly defining the nature of the business and the products being developed before permissions are granted. This can be a hurdle for establishing new businesses and fostering a culture of innovation. 

While we initially focused solely on antibody production, we recognised the need for in-house R&D. This department has been instrumental in developing innovative new products. One such example is a specialised glass surface that allows researchers to capture clear microscopic images of freely moving cells, a challenge in traditional methods. This unique product has garnered international recognition for Shikhar Biotech.

How do you ensure the quality and effectiveness of the antibodies you produce?

Shikhar Biotech prioritises quality. Our entire production process is ISO 9001 certified. Every step is clearly defined and documented. We use only rigorously tested raw materials and only highly skilled personnel are involved in antibody production. Most importantly, each antibody is accompanied by comprehensive data. Researchers can use this data to assess the antibody’s suitability for their specific research needs. They rely on this data, not just trust in our company, to make informed decisions. In fact, some companies even send their antibodies to Shikhar Biotech for validation, a testament to our expertise in this area.

As the leading antibody producer in South Asia, how does Shikhar Biotech compare to companies in Europe and America?

While Shikhar Biotech is the leader in antibody production within South Asia, we acknowledge the size difference compared to European and American companies. However, we differentiate ourselves through our rigorous antibody testing procedures. Many other companies prioritise speed over thorough testing. Some companies even send their antibodies to Shikhar Biotech for validation before selling them. In this way, Shikhar Biotech plays a vital role in ensuring the quality of antibodies used in research globally.

With the rapid evolution of biotechnology, how does Shikhar Biotech stay competitive?

Staying competitive in this rapidly evolving field requires a strong commitment to research and development. We constantly strive to develop new and innovative products. However, large companies with significant resources have a distinct advantage in this area. Therefore, Shikhar Biotech focuses on providing high-quality production and validation services to other companies developing novel products. For example, we transitioned from producing polyclonal antibodies to monoclonal antibodies, aligning with the current scientific shift. While we may not compete directly with companies developing new antibodies, we contribute by ensuring the quality of these products through validation services.

What are the challenges you face regarding regulatory hurdles in the medical sector?

The medical sector, by its nature, has regulations to ensure patient safety. For our products, the effectiveness can only be truly determined by the end-user in a specific research application. Standardised testing for every product is not feasible. However, Shikhar Biotech adheres to all regulatory requirements regarding our overall operations and the permissions needed for our production facility, which utilises goats to produce antibodies. We are grateful for the Department of Industry’s support in facilitating a smooth regulatory process for Shikhar Biotech.

Is there any ongoing new research you want to talk about?

We are currently engaged in research to develop antivenom for snakebites in Nepal. Currently, antivenom is imported from India, and there are concerns about its effectiveness against Nepali snake venom. With government permission, Shikhar Biotech has begun collecting venom from different snakes and immunising animals to produce antivenom. This research holds promise for improving healthcare access and outcomes in Nepal.

There is talk of personalised medicine and targeted therapy. What is Shikhar Biotech’s vision in this area?

It is important to clarify that Shikhar Biotech is a research company, not a therapeutic company. However, we have a strong desire to contribute to personalised medicine, particularly for cancer patients. For example, different drug combinations may be more effective for individual patients. Unfortunately, unclear regulations have hindered our efforts in this area. We believe that we could play a valuable role in testing the effectiveness of different drug combinations for individual patients, potentially leading to more effective cancer treatment.

What are the main challenges and opportunities for biotech companies in Nepal?

Let’s start with the opportunities. There is a strong interest in science and technology among Nepali students, particularly bright students. This is in contrast to some countries where bright students often gravitate towards easier fields. Nepal’s unique flora and fauna also offer immense potential for new discoveries in medicine.
Regarding challenges, the lengthy process of obtaining research and development permits can stifle innovation.  Another hurdle is the lack of clear and streamlined regulations.

Did you work on the Covid 19 vaccine?

While we were not directly involved in developing a vaccine, we did contribute in the early stages. During that time, we utilised our facilities to test the neutralising efficiency of potential vaccine candidates. However, the lengthy approval process in Nepal significantly hampered our progress. By the time we received permission, other countries had already made significant advancements and developed vaccines. The delays were due to regulatory hurdles, not limitations from the Department of Animal Health who oversaw our facility.

Have you ever encountered challenges related to intellectual property?

Fortunately, we have not faced significant issues with intellectual property so far. As I mentioned earlier, our unique glass coverslips are not currently patented. We have chosen to keep the technology a secret for now. While there is a possibility someone could reverse-engineer the product, patenting is not our primary concern. For our antibodies, the target proteins often are not patented. This allows other companies to develop different antibodies against the same target, so patenting would not be particularly advantageous in those cases.

How do you collect data and analyse the effectiveness of your products?

Our team conducts all antibody testing in our own laboratory. The data is then meticulously analysed by our team of paramedics. One key method we use is western blotting. This technique generates images (blots) that reveal protein patterns. These blots are then presented to scientists for evaluation. The data allows scientists to assess the antibody’s specificity and binding capacity, which are crucial indicators of effectiveness.

With the rising cost of medicine, how can we make treatments more affordable and accessible?

Shikhar Biotech is not directly involved in the medical field, so I cannot speak with complete authority. However, medicine prices in Nepal tend to be lower than in many other countries, reflecting the economic reality here. Despite this, some medications may still be out of reach for many Nepali people. To truly reduce costs, the government can play a vital role by streamlining regulations for pharmaceutical companies. Excessive bureaucracy and hurdles create delays and raise production costs, ultimately impacting consumer prices. Another factor is production efficiency. Ideally, we could produce more raw materials domestically rather than relying on imports. In my view, these are the key areas to address for improving affordability and accessibility of medicines.

How do you address ethical concerns regarding animal testing in antibody production, particularly the use of goats?

We understand and take ethical considerations very seriously. The concern you raise about injecting goats to produce antibodies is a valid one. We carefully evaluate the process and ensure it adheres to the highest ethical standards. The goats receive proper care, including specialised treatment and monitoring of their health. We believe this approach provides a benefit to these animals, extending their lifespan beyond what they might experience otherwise. Furthermore, we operate according to the strictest animal ethics protocols. For human samples, as we primarily work with research-based applications, ethical concerns are less prevalent. However, if human clinical samples are used by collaborators abroad, the research protocols would undoubtedly address ethical considerations as it is for the greater good of humanity.

What should companies do when a product, like the AstraZeneca Covid vaccine with its reported side effects, faces safety concerns?

There is no single approach for companies in such situations. The response depends on several factors, including the level of investment in the product. If side effects are identified after administering a vaccine, the crucial steps are to determine if a safer alternative exists and whether it is affordable. Ultimately, a company may need to withdraw the product if a safer option is available. Regulatory bodies play a critical role in guiding such decisions. While multinational companies are often profit-driven, regulations exist to prevent them from putting profits before safety. Transparency is paramount. Scientific companies should never conceal data, as it is a clear breach of ethical conduct. Following established protocols and regulations is essential in such situations.

Does Shikhar Biotech engage in collaborations and partnerships?

Absolutely. Collaboration is essential for us. We have an extensive partnership with Absolute Biotech in the UK, as well as partnerships with Absolute Antibody and ImmuQuest. Recently, we have been in discussions with a Chinese antibody company. Additionally, I am meeting with representatives from eight or nine other companies during my upcoming trip to the United Kingdom. We previously had a long-term partnership with the University of Sheffield, although our collaboration isn’t as active currently.

What are your long-term goals and aspirations for your biotech company? How do you plan to expand your reach and impact in the coming years?

For Shikhar Biotech, my long-term goal is to establish ourselves as the go-to company for antibody validation. Ideally, we want companies worldwide to recognise Shikhar Biotech as the trusted source for ensuring the quality and effectiveness of their antibodies. This would solidify our position as a leader in the global antibody validation market.

Looking beyond Shikhar Biotech, I envision a thriving biotech sector in Nepal. Currently, there are around eight or nine biotech companies in Nepal, each working on innovative projects. However, to truly propel the industry forward, we need a critical mass of 40-50 companies. This would foster collaboration, accelerate research and development, and create a robust job market for talented scientists. A flourishing biotech sector would inspire more students to pursue careers in this exciting field. Nepal is fortunate to have a bright pool of young science and technology enthusiasts. With a vibrant biotech industry, these students would have the opportunity to contribute their skills and knowledge to groundbreaking discoveries.

Ideally, a robust domestic biotech sector would allow Nepal to produce many of the diagnostic tools and medications currently imported. This would not only reduce costs but also keep Nepali capital circulating within the country. While Shikhar Biotech currently focuses on research antibodies, my long-term vision extends to the production of therapeutic drugs in Nepal. This would be a significant leap forward in Nepali healthcare, providing patients with greater access to life-saving treatments.
Overall, I am optimistic about the future of Nepal’s biotechnology sector. With continued investment in research and development, streamlined regulations, and a spirit of collaboration, Nepal has the potential to become a major player in the global biotech landscape. Shikhar Biotech is committed to playing a leading role in this exciting journey.