Eurofins CDMO Alphora Inc. (Canada) Announces the Launch of its Biologics Initiative focusing on mAbs and Therapeutic Proteins
2023年10月4日 - 7:30PM
ビジネスワイヤ(英語)
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)).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231004217416/en/
For further information: Cheryl Young, HBSc. VP Business
Development & Project Management Eurofins CDMO Alphora Inc.
Cheryl.Young@bpt.eurofinsca.com
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