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Role of CDMOs have evolved over the years in supporting product innovation & development: Windlass
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Shardul Nautiyal, Mumbai
January 19 , 2021
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The role of contract development and manufacturing organizations (CDMOs) have evolved from offering just manufacturing capabilities to supporting in product innovation and development, according to experts associated with the CDMO industry.
In the last few years, the R&D expertise of leading CDMOs is at par with multi-national companies. For instance, 70% of the new products being launched in the Indian Pharma Market (IPM) today are coming from leading Indian CDMOs. This has happened due to enormous focus and investments by CDMOs like Windlas Biotech in R&D, CGMP, automation and portfolio.
“By investing in capacity building skills and competence around “New chemical entity” research services, Indian CDMOs can leverage the infrastructure created for developing generic medicines and create tremendous value for themselves as well as for the nation,” said Hitesh Windlass, managing director, Windlas Biotech.
As a leading CDMO in India, Windlas Biotech has a strong Innovation Board with leading clinicians and academicians in the drug development field working on several short, medium and long-term projects.
“We have partnered with large multinationals and Indian pharma companies across the world to bring innovative products to market. These innovations are focused on three themes – improving patient compliance, exploring novel drug delivery systems and reducing cost of therapy,” Windlass explained.
To spur the growth in contract manufacturing, government needs to simplify the clinical trial requirements and expedite the regulatory product approval pathway. It can create an “Expedited review coupon” kind of system (like the US FDA) that can help smaller companies bring their disruptive innovation to market faster.
The company has partnered with a US-based biotechnology company Mateon/Oncotelic to develop an ayurvedic drug against Covid-19 in India. The product known as “PulmoHeal” is a formulated plant extract of the indigenous plant Artemisia. It is the first herbal drug showing promise against Covid-19 through TGF-ß inhibition and is expected to be effective through the entire infection cycle. Our open label, randomized, multicentre, placebo-controlled clinical trial is nearing completion and we are observing highly promising and statistically significant impact on patient recovery. Encouraged by the interim data, we are adding additional sites including AIIMS Delhi and extending the inclusion criteria to sicker patients. The active component of “PulmoHeal” is highly pure and special form of artemisinin.
The company presently has four manufacturing units and in total produce more than 2.2 billion doses annually. Its products are sourced by leading multinational and Indian pharma companies. The company has strong expertise in anti-diabetics, cardiovascular, central nervous system and gastrointestinal drugs.
“We have 3 dedicated R&D laboratories focused on pharmaceutical formulations, nutraceutical and Ayush formulations and novel API synthesis respectively. Apart from manufacturing and drug supply, we provide custom development services to our clients to help differentiate their products. We are also engaged in developing several breakthrough platforms technologies based patented formulations that we have exclusively licensed from leading academic institutes in India and foreign biotech companies,” Windlass informed.
Windlas Biotech is always on the lookout for adding synergistic capabilities that can expand its product basket for the customers. It is also evaluating expansion in terms of our manufacturing footprint in different dosage forms as well as our R&D infrastructure. It is backed by private equity investor Tano Capital and are looking at acquisition opportunities that help us further our mission.
“Our plan is to emerge as a leader in ethnobiology drug development, leveraging on the rich ayurvedic/homoeopathic knowledge coupled with cutting-edge clinical research and rigorous modern manufacturing practices. Our initial foray in pulmonary health will be further expanded into other areas where together with our partners, we have established first-mover advantage i.e. TGF-ß targeted therapies in collaboration with Oncotelic. The imminent launch of PulmoHeal together with a respiratory mobile app developed by Oncotelic using its artificial intelligence (AI)/cluster computing platform with IBM provides personalized care that is consistent with ayurvedic philosophies,” Windlass concluded.
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