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.”
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.