Eurofins CDMO Alphora Inc. announced 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.
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