The two companies have worked together to develop the recombinant human Alkaline Phosphatase (recAP) program since 2011, as KBI Biopharma provided initial development and current good manufacturing practice (cGMP) production for early clinical use.
AM-Pharma’s treatment has completed a Phase II trial; the company has signed the commercial manufacture agreement with KBI Biopharma, as it looks towards a Phase III trial and potential biologics license application (BLA).
The agreement itself will see KBI Biopharma conduct drug substance manufacturing, as well as process characterization and validation work, for the Phase III trials. Dependent on the results of the trial and a potential BLA, KBI Biopharma will then continue to provide drug substance manufacturing and release for commercial uses.
The recAP program is being investigated for the potential treatment of sepsis-associated acute kidney injury (SA-AKI), a disease that currently has no approved treatments.
KBI Biopharma has taken on the work after last year announcing a $150m (€126m) investment to establish a facility in Research Triangle Park, North Carolina. The commercial-scale facility will house six 2,000-liter, single-use bioreactor systems, which the company states allows the space to produce more than 100 commercial batches per year.
KBI Biopharma CEO, Dirk Lange, told BioPharma-Reporter that the company had expanded its global manufacturing capability to meet growing demand for clinical and commercial manufacture in Europe and the US.
AM-Pharma’s drug candidate is constructed from two naturally occurring human isoforms of the AP enzyme. Providing further detail on the manufacture of the reCAP enzyme, Lange explained that, due its complex nature, working with AM-Pharma required a tailored development and manufacturing approach, compared to monoclonal antibody manufacture.
In terms of where the project currently stands, Lange stated “We are now entering into the process optimization phase to ensure the molecule can be manufactured in a robust and cost-effective way. From there, we move into process characterization followed by performance qualification (validation) of the process.”