The contract manufacturing organisation (CMO) will perform process development, scaling up and cGMP manufacturing for SELK2, a mAb aimed at Crohn’s Disease and Multiple Myeloma, for use in a Phase I clinical trial.
Cytovance will perform both upstream and downstream process development as well as analytical method development and cGMP bulk drug manufacturing and final product fill/finish and release, the company told BioPharma-Reporter.com.
Bioreactors
The CMO will use both disposable single-use bioreactors and stainless steel in the manufacturing, said Valerie McDonnell, VP of Business Development. Whether to operate single-use or non-disposable equipment in biologics manufacturing is currently subject to debate in the industry.
The main challenges when scaling up production and developing proteins are “aggregation, precipitation, yield or host cell protein clearance,” McDonnell told us. The company has experience working with difficult mAbs such as IgM (Immunoglobulin M), she said, as well as “many challenging molecules including fusion proteins, enzymes, cytokines, SMIPs [small modular immunopharmaceuticals] and pegylated proteins.”
This is the latest of several agreements between Cytovance and Selexys to develop and manufacture products for Selexys’s Phase I and II trials, McDonnell told us. Elsewhere, Cytovance struck deals earlier this year to manufacture mAbs for Pamlico BioPharma and Precision Biologics. In January the company broke ground on a multi-million dollar extension to its headquarters in Oklahoma City. It is expected to be completed next month and will contain a 10,000-sq ft manufacturing facility.
Selexys is a private biopharmaceutical company focused on drugs treating inflammation, thrombosis and cancer metastasis across a range of diseases. Like Cytovance, it is headquartered in Oklahoma City.