European Pharmacopoeia Commission Sets Quality Requirements for Live Biotherapeutic Products

April 18, 2018

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

The European Pharmacopoeia Commission

on Apr. 16, 2018 that it has set, at its 160th session, quality requirements for live biotherapeutic products (LBPs) for human use. The quality standards include a general monograph on Live biotherapeutic products for human use (3053), as well as two general chapters: Microbial examination of live biotherapeutic products (LBP): test for enumeration of microbial contaminants (2.6.36) and Microbiological examination of live biotherapeutic products: test for specified microorganism (2.6.38).

LBPs are medicinal products that contain living micro-organisms such as bacteria or yeasts. These micro-organisms have a positive influence on the health and physiology of the host. The most common species are the bacteria Lactobacilli, Bifidobacteria, some Streptococcal species, Bacillus clausii, and the yeast Saccharomyces cerevisiae var boulardii.

There are many LBPs available on the European market, however, until now, standards have not set out in the European Pharmacopoeia (Ph. Eur.) to ensure their quality. To address this gap, the European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs. These general chapters describe methods for the enumeration of contaminants and for the detection of specified microorganisms. In addition, the standards provide decision diagrams (in both chapters) describing how to establish a suitable testing method, a supplementary tool to control the quality of LBPs.

Requirements include a full morphological, biochemical, serological, and molecular characterization of the strains used (because the therapeutic characteristics are strain-specific). The tests aim to ensure the absence of antimicrobial resistance or any other virulence factors in LBPs. Verification of the potency by enumeration and microbial contamination detection are also important requirements.

These three new texts will be published in Ph. Eur. Supplement 9.7 and will become effective in April 2019.

Source: