Microbiome

Eurofins Biopharma Product Testing provides GMP testing for Live Biotherapeutic, Bacteriophage therapy, and Microbiome products. We test products for identity, stability, potency, process variation, and the absence of contaminating microorganisms across different stages of clinical trials by performing Whole Genome Sequencing (WGS) using Next Generation Sequencing (NGS) technologies. We also provide bioinformatics services that serve as the minimum standard requirement for microbiome and related product testing.

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Live Biotherapeutic Products (LBPs) as a new category of medicinal products for the American and European markets. Similar to other drug products, strict good manufacturing practices (GMP) should also apply to the production of LBP. For LBPs, the GMP requirements must ensure the viability of the desired microorganism(s) both in the final product and at the end of the claimed shelf life of the product.

Despite these guidelines, there are many gaps in the knowledge of drug regulatory requirements for LBPs, partly because microbial growth and viability are challenging to control at the production level and the product lifecycle. Therefore, the characterization of the microorganism(s) becomes of the utmost importance to LBP quality documentation.

Amongst an array of tests suggested for LBP testing, the EMA and FDA have given prime importance to the whole genome sequence characterisation of the strain in the final product dossier.

Eurofins uses validated methods for DNA/RNA extractions, NGS library preparations, NGS sequencing and bioinformatics analysis that are compliant with GMP requirements.

We have developed a complete workflow for microbiome product risk assessment recommended for market authorization.