Excess vaccine-making capacity may get utilised in 3-5 years: Merck Life

Some 40-50 firms in India are getting into mRNA technology, says Aditya Sharma, senior executive of the German company

Germany’s Merck Life Sciences assisted vaccine makers during the pandemic for equipment and solutions. It is an expert in the mRNA space in microbiology and the in-demand platform for vaccines and biologics. In a conversation with Sohini Das and Anjali Singh on an online platform, ADITYA SHARMA, head of bio process business for India region at Merck Life Sciences, spoke about the prospects of mRNA tech, excess capacities and ways to use them. Edited excerpts of the interview follow after a note about what mRNA technology is.

(mRNA — messenger RNA— is a molecule containing instructions for cells to make a protein. The molecule travels within a protective bubble called a Lipid Nanoparticle. It can be used to make vaccines or treat some diseases.)

Can you tell us about your business-to-business (B2B) work during the pandemic when you worked with major vaccine manufacturers?

As you all know Covid-19 pandemic was a very tough time. It was like a race against time and everybody was trying to get a vaccine in the market to save lives, and we are one of the critical partners for many of these vaccine producers. They are dependent on us for certain technologies and our role is how do we make sure that we provide all these technologies product solutions services to our customers on time so that we can ramp up vaccine production. This involved a lot of coordination within Merck, with our supply chain or various teams who are managing supply chains in India and globally, and also working closely with customers trying to understand what they are trying to do and what kind of demand is coming from them. The situation was very fluid and we were getting suddenly racked up by demand and we had to go back and figure out how to make sure that we supplied these products in time.

The other challenge was that globally most of the vaccine manufacturers and countries were all demanding these products. So it was a very difficult time and it was a huge task to make sure that we moved the right products to the right customers at the right time. I think those were the challenges, but I'm very happy that as an organisation we could support it.

How is making the mRNA vaccine different from the other platforms?

One can make a vaccine from different pathways. You can have a bacterial vaccine where you can have bacteria as a whole. You can have a vaccine where you could have bacteria which actually gives you immunity, and then viral vaccines. mRNA is a different platform, but when you look at the overall process, it’s similar. The kinds of steps which are there in the manufacturing process include chromatography, TFF operations, and different kinds of purification technologies. In that way it would be more or less the same though the steps might be different here and there in the full manufacturing process. From the storage perspective mRNA vaccines have to be stored at very low temperatures and it was a major challenge which we were seeing with Pfizer and some of these other vaccines. All the manufacturers who are in mRNA space are trying to develop formulations which would be stable at 2 to 8 degrees Celsius. For example, the vaccine Gennova has come up with. I think it's much more stable. I think there is a lot of R&D which is going on to make sure that in a country like India which is so hot and humid we have rural areas where that kind of cold chain is not available. How do we make the right formulations available where we can just store this vaccine in the fridge and deliver it to patients.

What are the advantages of the mRNA tech platform?

The advantage with mRNA is that it's quite agile; it's very adaptive. You can use mRNA very quickly against different diseases and its scalability is very quick. So low temperature, storage and pathway are the issues along with the synthesis of the MRNA sequence and encapsulating it with the lipid nano particle.

Are you now focused on providing solutions or supplying equipment to vaccine makers?

As an organisation we have both equipment and services around it. Some of our customers already have a facility that they want to repurpose. They will buy equipment from us. Some of them already have stocks of their own consumables and we give them a lot of technical support to see if their existing consumables can be used in this process just to shorten their timelines. Some of the customers are looking for single use facilities which are easier to set up and we quickly turn around some of them are looking for multi-use hardware. We are working with these customers to understand and provide that kind of consultancy as to what we think is the right thing to do.

What role have you played in the mRNA vaccine scene globally and in India?

So from the global perspective, we have been working with some of these large global manufacturers and different institutes. Merck scientists are engaged with our customers and these different researchers to enable them to come out with the right formulation or scale up the process. Even when there is a technology transfer from a global company to an Indian company we engage very closely with our global colleagues and also the customers here to make sure that the transfer is done in the right way so our customers are able to reproduce as much as possible.

Are Indian pharma players also warming up to the mRNA technology?

The capabilities which exist in India are very limited because the technology is still very nascent. But having said that, there are many players who are getting into mRNA tech. Maybe 40-50 players are getting into mRNA at the moment in India. It's a very recent technology at this point in time definitely there is limited development of the talent at the technologies. Since we are one of the major solution providers in the industry almost every manufacturer who works in India is closely associated with us. So we see many inquiries and we work with them.

Are there any supply chain challenges in mRNA based production?

As such nothing very unique is required, but one needs to have a good supply of lipids. In terms of other purification technologies it's not very different from a biosimilar or a regular vaccine. Large multinational companies have actually expanded their facilities to make sure that there is no supply disruption around it. With Covid subsiding, there is a lot of capacity which is available with many of these life science companies like us where we can work closely with mRNA manufacturers to provide their technology. There is a lot of capacity available right now and I don't think there should be a challenge in terms of supply chain for mRNA scale up and manufacturing

According to you, what is the solution to this excess capacity?
 

So there are two aspects to it - one is the excess capacity which is lying with players like us. We have invested substantial amounts in expanding our facilities around all our technologies in the last couple of years. The second aspect is that our customers who invested large amounts in building Covid facilities and as Covid-19 declined and then they are sitting with excess capacity. Customers are smartly trying to repurpose these facilities to make some mRNA-based products or another vaccine with that same facility. Some of these customers have approached us and they have asked us to look at their existing facility and ask for suggestions on what they can do to repurpose it.

The biosimilars market it's growing so fast right now and you are seeing new players setting up shops. So there is a huge demand globally for products like biosimilars. I think these capacities would be fully utilised in a time horizon of three to five years and probably we might need to expand more.