Cytovance to scale up mAb for Selexys’s Phase I trial

By Fiona BARRY

- Last updated on GMT

Cytovance to scale up mAb for Selexys’s Phase I trial

Related tags Immune system

Cytovance will use both single-use and stainless steel in its monoclonal antibody (mAb) manufacturing deal with Selexys Pharmaceuticals.

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 


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.

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