Eurofins CDMO Alphora Inc. Announces the Completion of a New Pilot Scale Biologics Development Facility

2024-01-17
Business Wire
抗体药物偶联物临床1期
MISSISSAUGA, Canada--(BUSINESS WIRE)--Eurofins (Paris:ERF):
Eurofins CDMO Alphora Inc. (Eurofins 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.
To learn more, please visit: www.eurofins.com/cdmo
About Eurofins CDMO Eurofins Alphora Inc.
Eurofins CDMO Alphora Inc. is a leading global Contract Development and Manufacturing Organization that provides clients with active pharmaceutical ingredients (“API’s”) / drug substance and drug product development for small molecules and biologics. Its service offering encompasses 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. Operating with facilities in Europe, North America and India, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. With over 61,000 staff across a network of ca. 900 laboratories in 61 countries, Eurofins offers a portfolio of over 200,000 analytical methods.
Eurofins Shares are listed on Euronext Paris Stock Exchange (Eurofins Scientific SE (EURONEXT PARIS: ERF)).
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