The agreement the antibody will be produced in Gallus’ commercial manufacturing facility in St. Louis, Missouri for use in ongoing Phase II clinical trials. The 30,000-square-foot facility has over a decade of commercial cGMP manufacturing experience, including the ongoing manufacturing of Stelara and Remicade for Janssen Pharmaceuticals.
Claire Ruzicka, senior marketing manager at Gallus, told Biopharma-reporter.com that details of the manufacturing process are confidential, although she did disclose that the site houses a variety of single-use and stainless steel upstream and downstream technologies and the bioreactors used are made by GE Healthcare Life Sciences.
The PSMA antibody produced at Gallus is designed to internalize into the cancer cell, release active anti-cancer drug, and destroy the malignant cell. The fully human monoclonal antibody-drug conjugate can target the three-dimensional structure of PSMA, a protein that is a clinically validated biomarker of prostate cancer which is expressed on the surface of prostate cancer cells.
“Our extensive commercial manufacturing experience and proven quality systems make Gallus an ideal partner to support Progenics in the manufacture of their anti-PSMA antibody," said Mark R. Bamforth, President & CEO of Gallus.
The St. Louis facility in May selected Tap Biosystems’ bioreactor system in order to determine which CHO cell lines are stable and produce the highest titre mAbs. The company says it’s a flexible facility, though, and can accommodate modular capacity built to clients’ specifications, including options for single-use or flexible stainless steel technology.
Gallus invested $5m in the facility to increase capacity just two years after a similar expansion.
Ruzicka noted that process development labs “were expanded and now we’re really putting a lot of effort in expansion of the manufacturing capacity. For example, a new suite will be dedicated to single-use downstream” operations.
In addition to its expansion, the company expects to add about 30 new employees by end of the year, she added.
The company also has a manufacturing facility in Princeton, New Jersey, with experience in clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint.
"Gallus has impressed us with their ability to meet our high standards, combined with the experience and expertise necessary to manufacture our anti-PSMA antibody,” said Nitya Ray, SVP of manufacturing at Progenics. “We look forward to a productive partnership with Gallus as we develop this product for patients in need of this therapy."