The Commission adopted the “Infliximab concentrated solution” monograph last month according to the European Directorate for the Quality of Medicines & HealthCare (EDQM), which said it marked the end of several years of development.
“The Ph. Eur. Commission embarked upon the setting of public standards for therapeutic monoclonal antibodies (mAbs) in 2014 with a pilot phase and following extensive consultation with its stakeholders.”
The EDQM added that the collaborative approach was required to give the monograph the flexibility needed to accommodate the process-dependent heterogeneity associated with mAbs and their production.
“The approach used to set the monograph specifications is oriented towards promoting flexibility, notably in addressing process-dependent product heterogeneity.
“Significantly, criteria for verifying the performance of analytical methods are included, which will support robust methodologies, while the provision of examples of suitable procedures for complex assays enables the use of alternative methods,” the directorate said.
The newly adopted infliximab monograph will be included in Pharmacopoeia Supplement 9.6 and will become effective in January 2019.