MISSISSAUGA, Canada–(BUSINESS WIRE)–Eurofins CDMO Alphora Inc. is pleased to announce the launch of its Biologics initiative, as part of its vision to diversify and grow within the contract development and manufacturing industry in North America. The multiphase initiative aims to establish a facility at the 2070 Hadwen site within the Sheridan Research Park campus in Mississauga, ON, Canada. The first phase of the project, scheduled for completion by December 2023, is a 3,300 square foot pilot scale facility focused on mammalian cell culture (mAbs) and therapeutic proteins, providing non-cGMP process development and up to 200L scale production.
The $6.3M investment by Eurofins CDMO Alphora is supported by a $2.5M grant from the Ontario Government through the Ontario Together Fund (OTF). Further details are noted in the Ontario government press release, dated Sept 14, 2023. https://cuzzetto.com/ontario-welcomes-6-3-million-life-sciences-investment-in-mississauga/
The Biologics offerings will include analytical, upstream, and downstream development, process design and gap analysis, process scale up, bioassays as well as cGMP quality documentation.
The upstream processing laboratories will be equipped with cutting-edge technology that enables wide-ranging batch sizes capable of accommodating several mammalian and avian cell lines. With a team of experienced scientists in bioprocess engineering, Eurofins CDMO Alphora can prioritize speed-to-market by combining bench-scale technology with Design of Experiments (DoE) in the early development stages to map out an effective scale-up strategy designed to minimize cost and resources. These upstream processing advancements will not only enhance the efficiency, safety, and cost-effectiveness of biologics production but also boost patient access to life-saving therapeutics.
The downstream processing equipment enables the development of robust, economical, and scalable processes in line with Quality by Design (QbD) principles. The analytical laboratory will provide development of a wide range of bio-analytical assays for cGMP and non-cGMP applications to support process and drug candidate characterization, providing clients with an integrated solution for the manufacturing of biologic drug candidates while compressing timelines and development costs. Further, Eurofins CDMO Alphora’s existing API and HPAPI expertise in linker and warhead development and manufacturing will help support clients with antibody drug conjugate candidates.
Leveraging Eurofins CDMO Alphora’s expertise since 2003 in small molecule drug development, production and analytical development, this biologics expansion will provide clients with an integrated suite of complementary technologies, further strengthen Ontario’s supply chains and help bridge the gap in Canada’s biologics industry landscape.
To learn more, please visit: www.eurofins.com/cdmo
About Eurofins CDMO:
Eurofins CDMO 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.
Eurofins CDMO is part of the international network of Eurofins laboratories.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. With over 62,000 staff across a network of 900 laboratories in 61 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
Eurofins Shares are listed on Euronext Paris Stock Exchange (Eurofins Scientific SE (EURONEXT PARIS: ERF)).
Contacts
For further information:
Cheryl Young, HBSc.
VP Business Development & Project Management
Eurofins CDMO Alphora Inc.
Cheryl.Young@bpt.eurofinsca.com