Indian vaccine makers have great potential in regulated markets: Mr. Aditya Sharma,Merck Life Science India

Indian vaccine makers have great potential in regulated markets: Mr. Aditya Sharma,Merck Life Science India


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  • Source: AP

  • Date: 03 Oct,2022

In this article, Microbioz India is pleased to share an exclusive interview with Mr. Aditya Sharma, Head of BioProcess business for the India Region – Merck Life Science

Could you go into more detail about the motivation for creating the MLab and its journey so far?

Life science is a sunrise segment in India. Over the last few decades, Indian pharma industry has strengthened its expertise in manufacturing and supplying quality generic drugs to address the growing need for affordable health care around the world. Both the government and industries in India have an aspirational growth outlook and we see the industry in India focusing on complex Biologics and other emerging novel modalities. This is a motivation to us to create a MLab in India and partner with the industry and academia to empower and develop the industry.

The journey so far has been exciting and successful. It’s been 5 years since M Lab™ Collaboration Center was created in Bangalore. The goal was to have a facility that provided the most conducive environment for biopharmaceutical manufacturers and Merck Scientists and Engineers to closely collaborate and work towards a unified goal of developing new therapies. And we were and have been able to achieve that and aim to continue to do so in the future. The expanded facility, which spreads out over 806 square meters (8500 sq.ft.) highlights Merck’s world-class technical and application expertise.

The M Lab™ Collaboration Center was created with a single point vision to be a non-GMP facility, that was fortified and intended to showcase technologies, recreate manufacturing environments, evaluate, troubleshoot processes and be the perfect platform to provide hands-on training and support to the industry, both local and global. The center has also provided our customers over the past five years, an opportunity to interact and get a first-hand, unbiased view of the innovation and breakthroughs that Merck has been doing to optimize better health systems and provide solutions to some of the toughest health challenges in the country.

How does the MLab empower those who are involved in the pharmaceutical and biotech sectors? Any case studies to highlight the contribution MLab has made to the Indian biotech industry?

The M Lab™ Collaboration Center is a hub, buzzing with ideas, innovation and activities that are targeted to upgrade and support our vision towards a better healthcare sector. The center is managed by an experienced team of engineers and scientists. As a center it allows people to have a look and explore the various technical solutions, test applications, assess technologies and optimize processes and understand the depth of work that is being carried out by the center at large, pursuing a unified objective of a healthier society.

The center helps:

  1. Support customers in their development process
  2. Gives them a feel and demo of infrastructure to Greenfield projects and Startups / Emerging Biotech Accounts
  3. Provides a first-hand experience to customers through prearranged and tailored trainings and orientations
  4. Pilot lab for non-classified trouble shooting and process development trials to customers
  5. Digital and advanced tools for remote troubleshooting and demonstration

What do you think about the biotech R&D situation in India? Do we innovate enough?

The biotech sector has come of age across the globe. With the pandemic showing humanity about what truly matters, i.e., health and sound healthcare systems, globally biotech, pharma, and medical fraternities at large are now in the forefront of all plans and developments of governments everywhere. R&D is being encouraged, now, more so than ever.

Preparedness seems to be the motto of the industry. The attention to R&D is helping to see continued growth in research in the biotech sector, including development of indigenous vaccines, and is also attracting high investments. The sector saw various units and sub-units of the larger industry come together, collaborate and work unitedly with a single mission to serve and save humanity.

The need of the hour is to further step up the R&D ecosystem in India, which establishes Indian Pharma industry not only in the generics space but also in Biologics. The Indian Ministry of Science and Technology has created research ecosystems through its biotech parks and incubators. There is a huge potential to establish the country as the global innovation hub of the future. This would need more investments in R&D, collaborations between Industry and academia and funding from the government and private parties.

What do you think about Indian vaccine producers concentrating on controlled markets?

Indian vaccine manufacturers have tremendous opportunity and potential to cater to the regulated markets. Merck is focused and aligned with the governments vision of upscaling from generics to complex biologics. As a nation we are playing a pivotal role as the largest vaccine manufacturers, catering to almost 60% of the world’s vaccine demands. We are right there with the world leaders working together to eradicate various diseases that plague humanity even today. India is slowly also starting to focus on innovative technologies like protein subunit, viral vectors, mRNA, adult vaccines and plasmid platforms which are scalable, which offers immense scope in the regulated markets.

What are the most recent innovations from Merck to help the nation’s vaccination needs?

At Merck, Our goal is to invest in using path breaking technologies to simplify treatment and make it accessible to all those in need, in collaboration with drugs manufacturers across the world and scale up to make treatments and therapies available to all.

We are always at the forefront of innovation and new technologies. The company presently focusses on intensifying process for faster processing, improving yield, purity and supporting on quicker regulatory approvals. With that focus as the driving factor, Merck has launched multiple technologies, Single Use systems, digital tools and automation for connectivity of Multiple Unit Operations to adhere to Industry 4.0.

Our recent acquisitions has enabled us to become one of the leading CMO players in mRNA vaccines and Gene therapy, offering an integrated CDMO across the value chain pre-clinical to commercial. In addition, we have also launched new product platforms for gene therapy and have specialized teams, enabling our customers to bring new curative treatments to market.

What is the roadmap for M-lab in the future?

Innovation, R&D, collaboration, and unifying industry and academia together to foster and enable technological advancements will be our priority going forward. We would continue to invest in our M Lab™ Collaboration Center, to bring in novel and innovative technologies that helps accelerate drug development programs. We also plan to partner and mentor early-stage Biotech companies by bringing in our technologies, knowledge and expertise.

Any further projects Merck is engaged in using gene therapy or other cutting-edge techniques.

Over the past two years, Merck’s Life Science business sector has made significant investments to advance traditional and novel modalities (mAb) (Monoclonal Antibody), ADC (Antibody-drug Conjugates), HP-API (high-potency API), viral vector, and mRNA (Messenger Ribonucleic acid)) through acquisitions, expansions and launch of new product platforms / technologies. There is an urgent need to efficiently manufacture these treatments to reach larger patient populations. Merck has acquired companies, which has enabled us to be one of the leading CDMO players in mRNA vaccines and Gene therapy, offering an integrated CDMO across the value chain from pre-clinical to commercial. In addition we have also launched new product platforms for gene therapy and have specialized teams, enabling our customers to bring new curative treatments to market.

ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three years. We are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. Our latest innovation and additional capacity help bring novel treatments to cancer patient around the world and reinforce our commitment to shaping the future of these novel modalities.

We are continuing to invest in solving challenges in novel modalities in development and manufacturing, working alongside drug developers to industrialize, scale and accelerate the path to deliver therapies to patients.

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