Rentschler Biopharma is a CDMO that produces eight marketed biopharmaceutical products, four of which were approved in 2023.
Von Braunmühl said that the companies his organization has worked with have achieved a 70% commercial-success rate. He credited the strong partnerships that Rentschler has built along with its communication and consultation expertise, which has helped developers enact successful CMC strategies. “Almost 25% of the FDA-approved biopharmaceutical products came through Rentschler,” von Braunmühl said. He pointed out that by outsourcing production to his company, large clients can focus on clinical trials and marketing. On the other hand, Rentschler also helps small companies to manufacture products for rare diseases, because they frequently don’t have their own manufacturing sites.
On the topic of manufacturing, von Braunmühl addressed Rentschler’s recent Milford, MA, facility expansion, marking the company’s largest capital expenditure in its 50-year history. The new site added 22,000 m2 in cleanroom capacity for 2000-L fermentors for GMP manufacturing. That expansion will help the German company better service the US market. Rentschler’s global team helped kickstart the facility, which is now serving its first customer. Von Braunmühl said that the new facility is ahead of schedule and already “running according to plan, which is not normal in our space.”
Rentschler also has a presence in Stevenage, UK, working with the Cell and Gene Therapy (CGT) Catapult. Von Braunmühl said that his company’s two strategic goals were to expand its US presence and to focus on new modalities. The Stevenage facility has enabled the company to work with AAVs and, more recently, lentiviruses, which von Braunmühl acknowledged is a market that is expanding quickly. The Stevenage site provides a robust infrastructure and an environment that is physically close to many of the company’s clients.
Von Braunmühl said that after a two-year downturn in the biotechnology space, positive signs are emerging. “We see normal biotechnology protein–antibody commercial market growing in the next couple of decades,” he said, noting that it was looking very healthy. Although he cautioned that the space will have its ups and downs, Rentschler Biopharma is committed to reviewing market needs and understanding upcoming trends so that it can give clients the best chances to succeed.
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