Indian pharma is making an evident shift from manufacture of chemical drugs to biologicals, according to Peter Salazar, head process solutions, Merck Limited.

The technologies involved in production of biologicals are entirely different. The companies need assistance to get the product to the market with advanced technologies. India is an important market for Merck. There is an imminent need for the pharma and biotech industry here to learn the latest techniques in process solutions besides comply with regulatory norms in India and globally. There are companies in India who have initiated discussions, he added.

Yet another transformation in the pharma and biotech industry is the adoption of single use technologies and small manufacturing processes. New off-patent drugs are biological drugs. The industry is building capabilities to manufacture biosimilars. This is where Merck has a great deal to offer. Its recent opening of the 8,500 sq ft. M Lab Collaboration Centre in Bengaluru is designed as a long- term assistance to the Union government’s Make in India programme. This facility has simulated an actual manufacturing environment where scientists and biopharma personnel can be trained to use the latest technology without a fee, Salazar told Pharmabiz.

“The biologicals manufacturing cannot happen without the right technology. Now the technology cannot be adopted unless the companies have the training. Nonetheless, training is not possible unless there is expertise and Merck is ideally positioned for the same,” he noted.

The challenges for the Indian industry are perceptible. The key being adoption of advanced technology from drug discovery to regulated markets submission. The biopharmaceutical manufacturers can use the services of M Lab to efficiently develop, scale-up and manufacture clinical and commercial scale formulations, he said.

Merck acquired US-based Millipore and Sigma Aldrich in 2010 and 2015 respectively to strengthen its expertise in terms of product portfolio for chemicals and equipment. “We can offer to the Indian biopharma industry which is in an evolutionary stage, the required technology starting from gene clone, cell culture, process controls and right up to aseptic fill finish. Since we have a wide range of offering, the industry can have hands-on experience for a lot of technologies under one roof. Merck is also keen to services a spectrum of companies spanning from large to small and medium units and starts-ups in related fields,” he said.

The M Lab Collaboration Centre is envisaged as a free service model for the industry. The service comes at no cost to the industry . Indian biopharma is receptive to our offering going by the interest evinced from customer enquiries, said Salazar.