The suggestion was put forward by Karina Boszko, from Polish API maker Polpharma, who told delegates at the European Directorate for the Quality of Medicines’ (EDQM) 50th anniversary conference in Strasbourg that biotherapeutics are a special case.
“Biotherapeutic products should not have the same monographs as medical products” she said, adding that instead the EDQM should focus on developing “general recommendations and requirements for their characterisation.”
Boszko, who was representing the European Generic Medicines Association (EGA), added by taking this approach the “European pharmacopoeia would establish defined general rules for the biotechnology industry and regulators worldwide.”
State of play
There are dedicated Ph. Eur. groups covering biologicals, blood products, single source biopharmaceutical products, raw materials for cell based therapy products and monoclonal antibodies.
Two of these – those concerned with biologics and blood products – already develop individual monographs. The raw materials group, in contrast, elaborates a general chapter on raw materials for cell based and gene therapy products.
An EDQM spokeswoman told Biopharma-reporter.com there are a “wide range of biotherapeutic products for which the Ph. Eur. needs to adapt its approach regarding general or individual monographs.
"In addition, it is not possible to elaborate one general monograph to cover such a wide range of products.”
Despite this she acknowledged that: “Monographs for biotherapeutic products need more flexibility than a monograph for a chemically defined substance.
“As we gain more experience the Ph. Eur. is translating the flexibility info working reality,” she continued, adding that “this has already started with the monograph on Factor IX recombinant.”