EMEA’s MAb Guidance Details Platform Manufacturing Validation

The European Medicines Agency’s (EMEA) new draft guideline on the production and quality control of monoclonal antibodies (MAb) says it is acceptable for firms to employ a “platform manufacturing” approach for production process development.

According to the EMEA, platform manufacturing is a concept where different MAbs are manufactured using an identical, predefined purification process, and each manufacturer has its own such process.

Under the draft guideline, “A ‘platform manufacturing’ approach can be accepted because it is not necessary to develop each new manufacturing process from scratch.” Instead, a process can be based on previously developed in-house knowledge and it may also be appropriate to make efficient use of available or shared equipment, the EMEA states.

However, any product-specific process and process changes should be validated separately, as each cell line — even if derived from the same parent cell line with a similar genetic construct — is likely to have different properties, the guideline states.

Although each platform process should be separately validated for its ability to remove viruses, for new products manufacturers may partially rely on validation data from other products using the same platform. However, the relevance of the data must be demonstrated and the firm must show that the validation is comparable, the EMEA says.

The guideline can be accessed at www.emea.europa.eu/pdfs/human/bwp/15765307en.pdf.