M104 - Biological Reference Standards for Multivalent Vaccines: Qualification Strategies and Challenges from a National Control Lab Perspective

Experience shows that the handling of compendial and especially non-compendial and in-house reference standards and materials are often a challenge for OMCLs (Official Medicines Control Labs). The qualification of biological reference materials by the manufacturer and the OMCL has a direct influence on the final results of analytical tests and is thus of extremely high importance. The replacement of the reference vaccine’ case study highlights the difficulties encountered by the manufacturers and National Control Labs dealing with biological materials and methods(e.g. :In vivo, ELISA), and how to overcome them.