Rentschler doubles cGMP capacity

According to a company spokesperson, the expansion in the main market for biopharmaceuticals doubles Rentschler’s cGMP-compliant production capacity in one fell swoop. Production for a long-standing client at the former Rentschler Biopharma Manufacturing Center (RBMC) Milford, which has been managed by Dr Patrick Cushing (VP Operations) since May, has already started, announced the globally active company, which co-produced around a quarter of the new biopharmaceuticals approved by the FDA in 2023. According to CEO Benedikt von Braunmühl, the company intends to use the increase in production capacity to expand in the area of highly complex biologics in the USA.

The new production line, which took around three years to build and approve, is the largest investment in Rentschler Biopharma’s 150-year history. According to Rentschler, the first engineering run of a 2,000-litre batch was recently completed.

The Milford site has been developed from a commercial single-product facility to a multipurpose plant with a bioreactor set-up with a capacity of up to 500 litres. The new, fourth production line at the production site near Boston has an additional 2,050 square metres of cleanroom space and includes four new 2,000-litre single-use bioreactors. This has increased the total area from 8,600 to 12,800 square metres since 2019.

“Our new production line is critical to growing our business and effectively serving the U.S. market,” said Tom Roberts, President of Rentschler Biopharma Inc. and General Manager U.S. “I look forward to attracting new clients and reliably expanding our partnership with existing clients.”