13/14 December 2022
A whole series of drafts of monographs was published in the issue 27.3 of Pharmauropa - among them Chapter 2.6.27 "Microbial Examination of cell-based Preparations" (previously "Microbiological Control of Cellular Products"). This chapter deals specifically with cell-based preparations or products where the examination for sterility cannot be applied according to EP Chapter 2.6.1. However, it does not deal with blood products or blood components.
The draft is available for comments until 30 September.
The chapter focuses on preparations where, on the basis of certain characteristics, a sterility test is not possible with the recommended methodology of Chapter 2.6.1. It also covers the selection of alternative test methods and their suitability. The present document deals with the following relevant issues:
1. Shelf-life - for cryopreserved preparations the durability is often only 3-4 days or sometimes only a few hours. Thus, a classical microbiological examination may not be possible prior to the application on the patient.
2. Sample composition - often it is in such a way that possibly microbiological contaminants are located on or in the cell and cannot be detected in the surrounding culture or transport medium - i.e. the used sample must be such that all components of the product are considered.
3. Sample Size - especially with products from individual donors or sometimes due to the limited capacity of the manufacture methodology the available sample size is limited for some products - i.e. sample size and selected test methods must harmonise regarding sensitivity and specificity.
4. Rational for Method Selection - the specific characteristics of the cell preparation must be considered in the selection of the test method. In the selection a thorough risk analysis of the potential sources of contamination can be helpful.
Following your registration on the Pharmeuropa website you can get to the complete Chapter 2.6.27 "Microbial Examination of cell-based Preparations".