Pharmaceutical Business review

Eurofins Alphora completes Canadian biologics development facility

The new facility is designed for the development and scaling of monoclonal antibodies. Credit: Michal Jarmoluk from Pixabay.

Located in Mississauga, Canada, the 3,300ft2 facility is designed for the development and scaling of monoclonal antibodies and other mammalian-based therapeutic proteins.

The facility will provide a comprehensive range of services, including upstream and downstream development, process design, analytical development, GMP QC testing, GMP Cell-Based Assays, and a scale-up capacity of up to 200L for pre-clinical and Phase I supply.

With the integration of advanced technology, the facility is capable of handling various batch sizes, both fed-batch and perfusion.

The analytical laboratory within the facility offers a broad spectrum of testing and bio-assays for both GMP and non-GMP applications.

This supports thorough process and drug candidate characterisation, offering clients an integrated solution that aims to streamline timelines and reduce development costs.

In a press statement, Eurofins said: “Coupled with extensive experience in linker and warhead development through its expertise in active pharmaceutical ingredients (API) and highly potent active pharmaceutical ingredients (HPAPI), Eurofins Alphora’s added biologics capacity supports fully integrated conjugation services for antibody drug conjugate (ADC) candidate development.”

Eurofins CDMO Alphora is engaged in providing active pharmaceutical ingredients (API’s) / drug substance and drug product development for small molecules and biologics.

The company’s service offering includes drug substance/API development, solid state research and development, pre-formulation, formulation and development, analytical development, Non-GMP & GMP manufacturing and clinical packaging and logistics.