Eurofins CDMO Alphora Inc. has expanded its API capacity and capabilities with the completion of its new API manufacturing facility at its site in Mississauga, Canada.

The new API facility adds 15,000 sq.-ft. of GMP processing and warehousing space which complements Eurofins CDMO Alphora’s existing API and drug substance manufacturing capabilities.

The addition of 2 x 2000 L reactors expands existing GMP plant capacity and supports API batches to the 125kg scale. The new plant provides additional capacity for Phase I through to commercialization programs to support a growing client base and pipeline. The facility is designed to handle up to Safebridge Class 3 compounds and includes two Hastelloy filter dryers to facilitate API isolation and drying. The reactor systems can support temperatures from cryogenic (-800C) to 2000C, as well as hydrogenations and biotage chromatography.

The API plant expansion aims to position Eurofins CDMO Alphora at the forefront of small molecule development and supporting the manufacturing of life-saving therapies. This capacity expansion will allow Eurofins CDMO Alphora to support existing and prospective partners to address expanding therapeutic indications and meet the growing demand for emerging therapies at clinical and commercial stages.