Gallus Enters Clinical cGMP Manufacturing Agreement with Symphogen
News Mar 01, 2014
Gallus BioPharmaceuticals, LLC (Gallus) has signed a manufacturing agreement with Symphogen, A/S (Symphogen), a private biopharmaceutical company developing recombinant monoclonal antibody (mAb) mixtures for the treatment of cancer.
This agreement includes process transfer and clinical stage cGMP manufacturing of Symphogen’s antibody mixture product candidates.
Gallus will employ the GE Healthcare Life Sciences Flex Factory™, a flexible single-use biomanufacturing platform, at their headquarters in St. Louis to manufacture product candidates for Symphogen.
“Gallus is delighted to partner with Symphogen in the process development and clinical supply of their antibody mixture candidates. Symphogen has developed unique technologies for the controlled, reproducible production of highly characterized mAb mixtures manufactured in a single batch. Gallus’ expertise in process development and scale-up will ensure high quality molecules are delivered to the clinic,” said Mark R. Bamforth, Gallus’ President & CEO.
“We are pleased to work with Gallus, a very experienced CMO with an extensive background in the cGMP manufacture of antibodies, ranging from early stage clinical programs to the commercial supply of approved therapeutics. We look forward to working together to advance our innovative cancer therapeutic programs” said Kirsten Drejer, CEO of Symphogen A/S.