Cel-Sci hopes “True Cold” gets warm reception in biologics sector
The plant, which will make Phase III trial stocks of Cel-Sci’s candidate head and neck cancer drug Multikine, features a range of low-temperature formulation, fill and finish and packaging suits that will be available to industry customers on a contractual basis.
Although Cel-Sci began talking about contract manufacturing at the plant in January, a recent filing with the US Securities and Exchange Commission (SEC) re-ignited interest in the service.
Company spokesperson Gavin de Windt told Outsourcing-pharma about the new offering and some of the advantages it can provide for biologics developers, starting with how it can help reduce manufacturing time.
He explained that since biologics tend to loose activity above 4ºC, firms without cold-fill capacity usually have to determine the precise impact of temperature on potency during manufacture, in a validation process that can delay launch by six months.
de Windt said that not only does Cel-Sci’s service bypasses this procedure it also removes the tendency to “over fill” vials to ensure products meet potency claims, which is a common and costly solution among biologics companies.
Cel-Sci hopes that “True Cold” will attract customers from the biotech and pharma sectors as well as government laboratories and academia. de Windt also suggested that CMOs that without a similar offering “may refer customers to CEL-SCI as well.”
He predicted that the continuing growth of the biologics manufacturing market as well as the eventual acceptance of pending US biosimilars legislation will continue to drive demand biologics and hence cold fill and finish services going forward.
According to the SEC filing Cel-Sci will charge $150,000 for an eight hour fill and finish when the Baltimore facility completes an ongoing validation process that was initiated in July.
Multi-tasking with Multikine
While contract cold-filling is likely to be an important part of the new plant’s output, as previously stated, its initial focus will be the production of Phase III trial stocks of Cel-Sci’s candidate neck cancer treatment Multikine.
The US Food and Drug Administration (FDA) gave Cel-Sci approval to conduct Phase III trials of Mutlikine earlier this year, also granting the drug orphan drug to as a neoadjuvant therapy of squamous cell carcinoma of the head and neck.
Cel-Sci also plans, if the drug is approved, to make commercial batches at the facility for supply to its distribution global partners Teva Pharmaceutical Industries, Orient Europharma and Byron Biopharma.
