Breaking the single-use paradigm? CMC Biologics to offer 12,000L scale runs

02-Jun-2016 - Last updated on 03-Jun-2016 at 10:06 GMT

Danish plastic? CMC Biologics adds 6,000L of single-use capacity at its Copenhagen facility. Image: iStock/Vladimir Nenov

Related tags Biotechnology Disposable Cmc biologics

Single-use manufacturing runs have been limited to 2,000L, but CMC Biologics says it will be able to offer 12,000L of commercial scale through its bioreactor configuration platform.

The contract manufacturer has expanded its facility in Copenhagen, Denmark adding additional cGMP production capacity through the installation of three Thermo Fisher 2,000L single-use production bioreactors and associated seed trains.

While expansions are standard within an industry which has continuously called for increased third-party capacity, SVP of global business development at CMC Robert Broeze told Biopharma-Reporter.com the firm’s “unique and proprietary bioreactor configuration” platform, 3PACK, means the new bioreactors can be run singly or in groups, simultaneously, sequentially or in staggered fashion, offering volumes up to 6,000L as a single run.

And with plans to install a further three 2,000L single-use bioreactors in 2017, the facility will host CMC’s 6PACK configuration, offering biologics makers up to 12,000L as a single run.

“Until now, a 2000L run was the largest run that could be achieved with single-use bioreactors,” Broeze told us. “And certainly, until now, 12,000L single use bioreactor runs have been unheard of in the industry.”

While single-use technologies have become fully adopted by industry, there has been some criticism, especially from large-scale biologics makers such as Pfizer, that disposable systems cannot be used efficiently for high volume products.

However, coupled with increasing titres, “CMC Biologics’ bioreactor 3PACKTM and 6PACKTM configurations have changed this paradigm,” he added.

“For our Copenhagen facility, the Bioreactor 3PACKTM facility represents the initial step toward implementation of a Bioreactor 6PACKTM facility - which will be identical to the Bioreactor 6PACKTM facility that we recently commissioned in our Seattle facility in 2015.”

The extra capacity will be made available for cGMP production for all of the firm’s clients, he added.

CMC Biologics has recently been contracted to make Factor Vlla CB 813d for Catslyst Biosciences, a cancer candidate for Immunocore Limited, a mAb for a potential malaria vaccine for the PATH Malaria Vaccine Initiative (MVI), and a mAb to treat Grave’s Orbitopathy for River Vision Development Corporation.