Back in 2020, Rentschler Biopharma signed a manufacturing agreement with BioNTech and Pfizer, to handle the downstream purification of BNT162b2, an mRNA-based COVID-19 vaccine being developed by the two pharma giants.
“What’s really special in this case is that until the pandemic, we were not active in mRNA production, but when BioNTech approached us, we knew we had the expertise and could deliver,” Pollano tells BioPharma-Reporter at Bio International 2023.
"We processed two billion doses for BioNTech / Pfizer and were able to work at light-speed, based on our knowledge in manufacturing and our experience in interacting with regulatory authorities.”
Hot on the heels of this partnership, the CDMO is ramping up its production capabilities and looking to scale globally.
Rentschler is currently building a new state-of-the-art facility in the Greater Boston area, that will double its global cGMP capacity.
It will add 22,000 square feet of manufacturing cleanroom space and have four new 2,000 L single-use bioreactors. It will also be highly automated and leverage industry 4.0 solutions.
The new location, adjacent to the company’s existing site in Milford, Massachusetts, is the “biggest investment in the history of Rentschler,” Pollano says.
The decision to expand its footprint in the US was primarily driven by client demand and feedback, he adds.
“Back in 2019, we had many discussions our clients in the US and the expectation was that we have a footprint in the US,” Pollano says.
“As a result, we took over an existing site and then decided to make an expansion, which will be operational by August next year. With 50% of our clients coming from the US, it’s imperative that we have the necessary facilities to support them. As we can see from Bio International, Boston is a hub for biotech and it will be particularly good to have a bigger presence here, very close to our clients and partners.”
When asked if he had any concerns about ramping up production or oversupply, Pollano said he is confident that there is a consistent and growing demand for Rentschler’s services.
“There is absolutely a strong demand, particularly in our market segment. The molecules are becoming more and more complex, targeting more dedicated, severe orphan diseases and this is exactly our playground. Our strength is in our niche and it is what we are known for in the industry,” he says.
“We are already transferring clients from Europe to Milford and we have new clients in the queue for the site – which is very exciting.”