PLANTATION, Fla. and MONTREAL, June 2, 2011 /PRNewswire/ —
Goodwin Biotechnology, Inc. (GBI), a full service CMO
focused on process development and GMP manufacturing of cell
culture derived biopharmaceuticals, and Alethia Biotherapeutics,
Inc., a biotechnology company focused on monoclonal antibody
development with a very sensitive and highly disease-tissue
specific proprietary target discovery platform, announced a
collaboration on the development of a mammalian cell line-based IgG
monoclonal antibody project that is anticipated to make a
significant impact in the treatment of selected cancers. Terms of
the agreement were not disclosed.
“AB-16B5 is a humanized IgG2 monoclonal antibody which targets
secreted clusterin for the inhibition of cancer-associated
epithelial-to-mesenchymal transition (EMT), and it has shown
positive pre-clinical results in representative cancer models
derived from various solid tumors,” notes Mario Filion, Ph.D.,
Executive VP and CSO at Alethia Biotherapeutics. “And, we are
pleased to select GBI as our development and GMP manufacturing
partner for our first product candidate.”
“We at GBI would like to echo that comment. We are pleased to
partner with Alethia Biotherapeutics on this important project,”
says SooYoung Lee, PhD and Senior Vice President of Operations at
GBI. “In the biologics CMO niche, we were among the first to
engineer the concept of ‘full integration’, which enables us to
work with our clients from Proof of Concept through the manufacture
of pre-clinical, and clinical trial products. It is a process we
termed ‘GMPnization’. In other words, we begin with the end in
mind. We employ appropriate stringent regulatory and quality
systems to supply product candidates during the development cycle
from the initial ‘production’ cell line development all the way
through scale up steps leading to the final cGMP compliant
manufacturing process and vialing of the final biopharmaceutical
product.”
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