The manufacturing deal will see Rentschler make Apeiron’s candidate monoclonal antibody - APN311 - for European clinical trials for Neuroblastoma, which is the most common form of childhood cancer in Europe.
Apeiron COO Manfred Schuster told BioPharma-Reporter that Rentscheler was selected as a replacement for the firm’s previous contract manufacturing organisation (CMO) from a shortlist of several contractors.
"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 specific technical biomanufacturing capabilities include Rentschler’s use of stainless steel tanks Schuster continued, explaining that: “Our product is manufactured in stainless steel bioreactors by using a eukaryotic (CHO) cell line.“
This was confirmed by a spokeswoman for the CMO who told us 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.
New CMO
Apeiron declined to name its previous CMO. 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 last contractor was also based in Europe.
The Austrian drugmaker also considered CMOs that use different fermentation technologies, however these 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.