MukoCell GmbH has hired Co.don AG to manufacture its autologous cell-based treatment for urological disorders.

The deal will see Co.don make the product – also named MukoCell – at its recently established human cell-focused manufacturing facility in Leipzig, Germany.

Matthias Meißner, Co.don director of corporate communications, told us MukoCell “is an innovative and gentle method for the surgical repair of urethral strictures.”

Image: iStock/Mohammed Haneefa Nizamudeen

A urethral stricture is a narrowing of the urethra caused by injury, instrumentation, infection, and certain non-infectious forms of urethritis.

MukoCell is approved for use in Germany.

Co.don board member Tilmann Bur cited the Leipzig plant as key, explaining “We repeatedly received enquiries about the availability of Co.don’s new site for contract manufacturing.

“We are proud to be able to offer customers the use of our technology for routine production, to cover capacity peaks, bridge initial phases or carry out research projects with GMP and non-GMP material.”

Manufacturing facility

Co.don’s Leipzig facility was licensed by German regulators last month.

The license covers production of Co.don’s own product Spherox, a cell-based treatment designed to repair knee cartilage.

The facility has also been approved to manufacture therapies for other companies on a contractual basis.

At the time Andreas Eberle, vice president and head of technical operations at Co.don said, “Building a new production site in compliance with all the regulatory requirements and legal standards for the pharma industry is always a time-consuming and cost-intensive process.

He added the firm “has been totally successful in mastering this challenge, from the start of the project to the award of the manufacturing licence, within the original budget, in just over two years.”

According to a 2018 presentation Co.don invested €10 million ($11 million) in the new plant, which has capacity to produce 4,500 units a year.

Previously Co.don has said offering contract manufacturing services at the plant will help cover “ongoing fixed costs and staff expenses of the plant and so achieve economies of scale that will impact the company’s own margins.

The firm also said the plant will “give us the opportunity of scaling up the production of our own product.”