Cel-Sci’s contract cold filling process could improve biologics

By Gareth Macdonald

- Last updated on GMT

Related tags: Embryonic stem cell, Barack obama

US Biotechnology firm Cel-Sci has unveiled a new manufacturing process, cold 4°C Aseptic Filling, that it claims can improve the shelf-life and potency of biologic drugs produced using stem cells.

Cel-Sci’s new approach, which will be carried out at the firm’s manufacturing facility in Baltimore, Maryland, is to conduct aseptic filling of small volume parenteral drug products and sterile growth media at 4°C rather than at room temperature.

Cel-Sci will both use the technique in-house for the production of trial stocks of its lead cancer candidate Multikine and provide it to industry clients and academics on a contractual basis.

Company CEO Geert Kersten explained that: “We developed this unique cold fill technology over the course of many years and built this new facility for our cancer drug Multikine at a cost of about $22m because we had not been able to find a company that could do a true 4°C cold fill for us.

Through our new service we will help advance new treatment therapies while also creating substantial shareholder value through the income from the facility​,” added Kersten.

Most observers believe that US president Barrack Obama’s reversal of the ban on government funded embryonic stem cell research last week will lead to a massive expansion in the amount of academic work in the field.

In time it is anticipated that the intellectual property (IP) emerging from the research will filter through to commercial drug development, meaning that Cel-Sci’s potential client base could be huge.

In addition, Biologics are one of the fastest growing sectors of the drug market, with almost all of the new blockbuster drugs to have emerged in the last few years belong to this class.

Since such drugs are temperature sensitive, Cel-Sci’s unique cold filling offering may well corner the market for pharmaceutical firm’s wishing to produce high-quality products in the next few years.

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