North America

Eurofins CDMO Alphora Inc. specializes in complex small molecule API pre-formulation and formulation development, process chemistry, GMP scale-up and analytical method development including highly potent molecules, from the pre-clinical to commercial development and manufacturing. Additionally, our biologics capabilities include the development and scaling of monoclonal antibodies (mAbs) and other mammalian-based therapeutic proteins. Our 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.

Eurofins CDMO facilities, based in Mississauga, Canada, have successfully been inspected and approved by international regulatory agencies such as the USFDA (2008-2011-2014-2016-2019) and Health Canada (2014-2016-2017-2019-2022-2023). The experienced quality team works with our clients to meet their phase appropriate quality and regulatory needs and is able to assist them with their regulatory filing; whether for preparation or review of CMC or DMF filings.