CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections.
Pamlico has contracted Cytovance Biologics as its CMO to develop a production cell line from the protein's amino acid sequence for GMP manufacture of phase I clinical material.
Richard Gammans, PhD, president and COO at Pamlico, told BioPharma-Reporter.com that the combination of Cytovance’s technology and the fact that they’re both located in Oklahoma City factored into the decision.
Cytovance will use both single-use and re-usable bioreactors for the production of the MAbs, Gammans said.
The deal comes as Cytovance recently expanded its manufacturing capacity in Oklahoma City. The new facility will house a 20,000 sq. foot warehouse and manufacturing facility.
Darren Head, President and CEO of Cytovance Biologics, previously told us that demand from small pharma to get into the biopharma space is growing.
Head added, "We are delighted to be working with such an innovative company that uses technologies from the Oklahoma Medical Research Foundation and advance the treatment of Streptococcus pneumoniae infections that are associated with over 50,000 deaths annually."
Gammans added that the infection is listed on the CDC’s (Centers for Disease control) roster of 18 infections that are a cause for concern because of the amount of drug resistance.
He added that Pamlico is just beginning the process of entering a clinical trial and “it’ll be a year or two before we get into clinical trials. Once we get into the trials, however, they’ll likely be fast-tracked” by the US FDA, he noted.
This process of transferring technology, building the cell line, engineering, process development and purification will move through stages as the process advances, Gammans said. We will be scheduled into Cytovance’s manufacturing cycles as needed.