Gallus BioPharmaceuticals Enters Manufacturing Services Agreement With Omni Bio Pharmaceutical

Gallus BioPharmaceuticals has announced that it has entered into a manufacturing series agreement with Omni Bio Pharmaceutical. The agreement between both companies will include cell line optimization, analytical development, and manufacturing scale up for Omni Bio’s alpha-1 antitrypsin (AAT) Fc fusion protein.

Omni Bio Pharmaceutical has been working to commercialize alternative uses of AAT. AAT is a common circulating serine protease inhibitor. A lack of ATT in the body can cause liver failure or chronic lung diseases, such as emphysema. Researchers also believe that AAT plays a critical role in modulating immunity, inflammation, and apoptosis, and can be used to protect certain cells from cell death. ATT has also been effective in the treatment of animal models of human diseases, including diabetes, graft versus host disease, and refractory gout, among others.

Gallus has been manufacturing pharmaceutical products for over 20 years, and has worked on manufacturing drugs, including Stelara, Remicade, and ProstaScint. The company’s primary facility is located in Princeton, New Jersey. Mark R. Bamforth, Gallus’ President and CEO, released a statement regarding the agreement. “Gallus is delighted to partner with Omni Bio in the cell line optimization, process development, and clinical supply of their AAT Fc protein,” said Bamforth. “We are confident that our deep process development expertise and direct experience with Fc fusion molecules will…meet Omni Bio’s goals.”

Dr. Bruce Schneider, Omni Bio’s CEO, also expresses confidence in the arrangement.  “We are also quite pleased to be entering into this relationship with Gallus…We look forward to working with the Gallus technical team to advance our recombinant AAT molecule into the clinic as efficiently and effectively as possible.”