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Nandita Vijay, Bengaluru October 18 , 2022
India cannot be ignored in bioprocessing capability as its qualified workforce and cost efficiencies propel ample growth prospects, said Aditya Sharma, head bioprocessing, Process Solutions Commercial, Merck Life Sciences.

Further, the strength of the industry in pharma and biotechnology small molecule manufacture, which are the generics, is well recognized across the regulated markets of the US, European Union, among others. The key driver for this capability is the talent pool. Even for bioprocessing, which is a different proposition altogether, the strength remains the same here because the industry has a good understanding of the market, which is a big opportunity for us, he added.

Many early stage entrepreneurs are getting into development of biosimilars, new areas like cell and gene therapy. This is because the pool of life sciences graduates, post graduates and doctorates are keen capitalize the huge market potential in bio processing where India can play a key role for the manufacture of biosimilars. There is an escalated demand at this point of time for high quality products at the right price point, Sharma told Pharmabiz at the sidelines of the Merck’s M Lab Collaboration Centre’s 5th anniversary in Bengaluru, which is among its 8 biopharma hubs in the world.

According to Sharma, regulations at this point of time are evolving. For instance, during the Covid pandemic several regulatory authorities gave the Emergency Use Authorization for the vaccines. This was based on relevant and reliable data to market the products proven to be safe and efficacious. Currently, it is observed that regulatory authorities are flexible, open to change, willing to understand the needs of the industry to enable faster treatment access to patient, he said.

In the area of startups too, there is considerable interest evinced to pursue bioprocessing and Merck Life Science is engaged with IITs (Indian Institute of Technology) and Mumbai’s Institute of Chemical Technology (ICT) on how to work closely in their labs. In fact, it is the professors of these institutes who are mentoring the early stage entrepreneurs.  Our endeavor is to support both the academia and the start-ups to help them scale-up operations which is a challenge. Many of these need the support of Contract Development and Manufacturing Organisations (CDMOs) to take their molecules forward. This is where our M Lab Collaboration Center comes in to chip in its expertise with bio-process solutions to help them get to the market, said Sharma.

India’s stand in bio-processing globally is of high repute. Our industry needs to get confident and move forward. There is a need to create a right balance between world class quality and cost of the products, he noted.

For Merck, India is one the strategic countries for growth. The company has made significant investments in India including this facility in Peenya which is where the filters will be assembled here. “Going forward, the company is looking to manufacture these in India”.

For the Covid vaccine development for India and the world, Merck which was an intrinsic part of effort, provided processes to make sure the end-product was safe for the people. We helped companies to mitigate challenges of tech-transfer in vaccine manufacture. In addition, we sorted out supply chain issues deftly to streamline raw material supplies to our bio processing customers, said Sharma.

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