Special Startup Series: Innovative purification matrix for affordable therapeutic proteins

Hyderabad based Sree Therapeutics has taken up the research initiative to develop novel affinity-based methods for purification of therapeutic proteins with affordable price

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Nearly 55 million people are suffering from Chronic obstructive pulmonary disease (COPD) in India. They are many reasons for COPD and one of the most important reasons is alpha 1 antitrypsin (AAT) deficiency. This hereditary disorder causes the alpha-1 antitrypsin protein to be reduced or missing from the blood. In this condition, the abnormal structure prevents the protein from getting out of liver cells, where they are produced to move towards the lungs where they are to be utilized.

AAT protein is necessary for healthy lungs, and the body uses it to protect the lungs from damage. If a person has low or no levels of AAT, their lungs may get severely damaged. Recent studies have shown that AAT deficiency leads to lung cancer, asthma, osteoporosis, and liver cancer.

In this backdrop, two Hyderabad based researchers observed many problems related to lung disorders while doing research in lung disorders like chronic obstructive pulmonary disease (COPD) and lung cancer. Dr T Sreelatha and Mr Vydyanath while exploring the options to treat the same, came to know about the AAT therapy and its advantages. However, when they came across the expensive price tag around the existing options, they decided to focus on reducing the cost of AAT therapy for the last two years.

They initiated their startup, Sree Therapeutics at the Bio-NEST incubator hosted in University of Hyderabad, with the help of BIRAC-Biotechnology Ignition Grant (BIG) programme through IKP as the BIG partner.

Explaining the idea behind their research, Dr Sreelatha says, “Each patient requires 5 gm of AAT in a week and 1 gm AAT costs approximately the US$ 400. The main reason behind the expensive cost is antibody-based resin using for purification of AAT. We thought to reduce the production cost by changing the purification method.”

She and her team searched many ways in this regard and came out with novel purification method i:e; dual ligand affinity based resin. This method is able to reduce the cost by 10 folds compared with the original cost.

“Our key focus is to develop novel affinity-based methods for purification of therapeutic proteins with affordable price,” adds Dr Sreelatha.

Overcoming initial challenges

Just like other biotechnology startups, funding was a major problem for Sree Therapeutics too. However, this problem of the company was solved in part by BIRAC through IKP (BIG funding).

Recollecting the same, Dr Sreelatha explains: “We incubated at Bio-NEST, University of Hyderabad. Funding and scientific network are very essential for any startup. We received exceptional support from IKP. Listening to Deepanwita madam is truly inspirational and we are lucky to be in Hyderabad. We are very happy to be having such a great supporter around us. In every step, the IKP team is helping us a lot. I am very thankful to IKP, Bio NEST- UoH and BIRAC team.”

Dr Sreelatha (left), Prof P Reddanna (middle) and Dr Vydyanath (right) at the newly inaugurated lab in Hyderabad.

While Dr Sreelatha considers regulatory issues as major obstacle yet her team is learning about the issues with the help of the government-sponsored program. She, however, feels it’s still a long way to go. “As students of science, we do not study regulatory aspects during our classes and when you are suddenly thinking about the application of technology and commercialization – this poses a major challenge as we cannot pitch without having proper knowledge of regulatory aspects.”

“We faced maximum difficulty in understanding the regulatory aspects and now trying hard to deal with the regulatory bodies,” points out Dr Sreelatha while at the same time adding, “Valuable suggestions and mentorship from the entire ecosystem are helping us a lot.”

R&D focus and product outcome 

The basic research work by the team itself is transforming into a product and the founders are happy for that. While they found out the issues connected with AAT production, their research helped them to overcome those issues. The primary focus of the team as of now is to develop dual ligand affinity based resin for purification of AAT in large scale.

“For doing sustainable business, by using dual ligand affinity resin as a platform technology we will purify other therapeutic proteins with affordable price without compromising product quality,” says Dr Sreelatha while listing out the strategy.

The team at Sree Therapeutics has developed a dual ligand affinity matrix for AAT purification at 10 ml scale. The aim now is to quantify the matrix up to 1 litre in one year.

“Existing purification methods are antibody-based methods. In this method, leachability is the main problem and it creates a hypersensitivity reaction. Besides that, this method is expensive and time taking procedure,” says Dr Sreelatha while explaining the problem area.

Again giving an idea about their proposed solution which she says is a simple procedure, she says, “We are using the negligible price of biological ligand and chemical ligand which are having more affinity towards AAT, purity is high, no leachability issue and price reduced by 10 fold as existing price. We will commercialize our AAT matrix within one year.”

Way Forward

Sree Therapeutics is eyeing global AAT market whose size is more than US$ 500 million. It is expecting the revenue by commercializing AAT and matrix. Having discussed the product with a few pharma companies, the company is excited with their positive response. Currently, the team is focusing on scaling the matrix up to 1 liter. Once done, it will consult the business mentors and proceed for commercialization.

Dr Sreelatha is confident of the support from the government agencies. “We strongly believe IKP, BioNEST- UoH, and BIRAC will support along the journey of our product into the market. More help is required with regulatory filings and dealing with regulatory bodies.” On the broader business outlook, she outlines:  “We want to do sustainable business. For that, we will continue our research in a translational way. After solving regulatory issues we launch our AAT in India. After scaling up, we will commercialize the product globally.”

We wish the founders a fruitful journey ahead.