Cel-Sci completes first Multikine batch at "Cold Fill" plant

By Gareth Macdonald

- Last updated on GMT

Related tags: Manufacturing

Cel-Sci’s recently opened “Cold fill” facility has passed its first manufacturing test by completing filling of a batch of the candidate head and neck cancer drug Multikine for a late-stage trial.

The Baltimore, Maryland, US facility provides filling capacity for temperature-sensitive biologic drugs with the emphasis being to minimise wastage and increase efficiency.

Cel-Sci use a technique known as cold 4°C Aseptic Filling, which was developed at the plant, for the production batches of in-house candidates like Multikine as well as drugs supplied by other developers.

The plant, which was validated in January​, cost around $22m (€15m) to develop and build and is one a handful of temperature controlled production facilities worldwide.

The manufactured Multikine batch is sufficient for the 880 patient Phase three trial that Cel-Sci and its development partners intend to start before the end of the year.

CEO Geert Kersten said that: “[With] the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial​.”

CMO business

And, while successful batch production is obviously an important step for Multikine’s development, completion of the project may prove to be as important for Cel-Sci in terms of its contracting business.

The ability to produce trial-sufficient quantities of biologics with the minimum of wastage is likely to be much in demand in the future as pharmaceutical firms increase their focus on developing hard-to-copy high-tech drugs.

Contract work would also provide a much needed boost for Cel-Sci’s revenue, which amounted to just $30,000 in the second quarter on an operating loss of some $5.3m.

Related topics: Processing, Processing equipment

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