The facilities’ offerings include upstream and downstream development, process design, analytical development, GMP QC testing, GMP Cell-Based Assays, and scale-up capacity to 200L for pre-clinical and phase I supply
The analytical laboratory offers a wide range of analytical testing and bio-assays for both GMP and non-GMP applications, supporting process and drug candidate characterization. (Credit: National Cancer Institute on Unsplash)
Eurofins CDMO Alphora, a Contract Drug and Manufacturing Organization based in Mississauga, Canada, is excited to announce the successful completion of its pilot-scale biologics development facility. Spanning 3,300 square feet, the facility is dedicated to the development and scaling of monoclonal antibodies (mAbs) and other mammalian-based therapeutic proteins.
The facilities’ offerings include upstream and downstream development, process design, analytical development, GMP QC testing, GMP Cell-Based Assays, and scale-up capacity to 200L for pre-clinical and phase I supply.
Equipped with cutting-edge technology, the facility can accommodate diverse batch sizes, both fedbatch and perfusion. Leveraging a skilled team of bioprocess scientists and state-of-the-art equipment, such as the Amber 250 and BioProfile FLEX2 Automated Cell Culture Analyzer, Eurofins Alphora prioritizes rapid market entry by implementing efficient, science-based scale-up strategies.
The analytical laboratory offers a wide range of analytical testing and bio-assays for both GMP and non-GMP applications, supporting process and drug candidate characterization. This integrated solution enables clients to streamline timelines and reduce development costs in manufacturing biologic drug candidates.
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.
Source: Company Press Release