Rentschler will make Apeiron’s candidate monoclonal antibody (MAb) for clinical trials as a treatment for the childhood cancer Neuroblastoma. Apeiron COO Manfred Schuster told Outsourcing-pharma.com Rentscheler was selected from a short-list of contract manufacturing organisations (CMO) in Europe and elsewhere.
"We considered also other experienced and established CMOs. Rentschler is a recognized manufacturer of market products and was able to start process transfer immediately and had similar technical capabilities of comparable geometries in comparison to our previous contract manufacturer. This is mandatory for efficient process transfer."
The manufacturing capabilities include Rentschler’s use of stainless steel tanks according to Schuster, who explained that: “Our product is manufactured in stainless steel bioreactors by using a eukaryotic (CHO) cell line.“
A Rentschler spokeswoman reiterated this, telling this publication that: "Our cGMP certified suites offer volumes from 30 L up to 2,500 L, ensuring the flexible and customized production and delivery of material," and that the CHO line would be used.
Apeiron said that Rentschler replaces a previous CMO it had worked with, but declined to name the company involved or say why it had sought a replacement.
However, Schuster did say Rentschler had won out over non-European CMOs with equivalent capabilities as selecting these would have “complicated process transfer,” which indicates that the previous contractor was also based in Europe.
The Austrian drugmaker also looked at contractors that use different fermentation systems, but were also rejected on the basis that – according to Schuster – use of the systems “would have triggered undesired changes of the current production process.”
Schuster could not comment when we asked if Rentschler will make APN311 if it is approved, however the statement announcing the deal indicated it covers production for “Late Stage Clinical Development and Market,” which suggests the CMO is at least in the running.
News of the agreement comes six months after Apeiron licensed commercialisation rights to the APN311 in Canada and Sub-Saharan Africa including South Africa to speciality pharma firm Paladin Labs.