The agreement will advance AM-Pharma’s recAP program towards commercialization with KBI providing drug substance manufacturing and regulatory support.

AM-Pharma’s recombinant human Alkaline Phosphatase (recAP) program is a potential treatment for Sepsis-Associated Acute Kidney Injury (SA-AKI).

Acute kidney disease affects hundreds of thousands of people globally and currently has no authorized pharmacological treatments.

Image: iStock/oatawa

Both firms partnered in 2011 to develop the program, which saw contract development manufacturing organization (CDMO) KBI Biopharma provide initial process development and manufacturing for early clinical use.

The program has completed a Phase II trial and the newly signed commercial manufacturing agreement looks towards a Phase III study and potential biologics license application (BLA) filing.

“KBI will conduct manufacturing and validation in its existing facilities, including its Durham, North Caroline facility,” KBI’s president and CEO Dirk Lange told BioProcess Insider. “The analytics and cGMP capabilities of KBI’s facilities are strongly suited for AM-Pharma’s product launch requirements.”

Under the terms of the agreement, KBI will perform drug substance manufacturing as well as servicing the ongoing process characterization and validation work.

Dependent on the clinical trial results, the CDMO will continue to support drug substance manufacturing and release for commercial use.

“We are increasing manufacturing capacity including additional equipment trains and qualified staff to meet the growing demand across the portfolio, but we are not building a specific or dedicated train for the program,” Lange told us.

He added that the process to manufacture recAP is “highly tailored to the product since this is a recombinant enzyme vs a standard platform monoclonal antibody process.”

KBI did not disclose any financial details associated with the deal.