From process development to clinical supply of your LBP
Live biotherapeutic products or LBPs are a class of biological products harnessing the therapeutic potential of live microorganisms, like bacteria or yeast, to modulate the host’s microbiota or interact with the immune system to prevent or cure diseases. The live biotherapeutic product market is experiencing a significant surge in growth driven by the growing recognition of the crucial role the human microbiome plays in health, coupled with advancements in microbiome research.
Eurofins CDMO has already produced a range of LBPs and can support the manufacturing of wild-type as well as genetically modified strains for clinical use.
LBP process development
- Optimization of the upstream process and harvesting procedure for aerobic and facultative anaerobes
- Drug product formulation development: liquids and solid drug products (i.e. after solidification via spray drying or freeze drying)
- Development of colon-targeted oral drug delivery products
- Analytical development (compendial or modified compendial testing)
- Dedicated, technical experts involved from early development to clinical manufacturing to ensure a seamless transition from development to GMP
LBP clinical supply
- Segregated, grade C suites up to biosafety level BSL-2
- GMP cell banking services (Master cell bank, Working cell bank)
- Single-use fermenter solution up to 40L working volume
- Closed and single-use production systems to maintain culture purity
- DP fill and finish for oral/nasal applications
- DP labeling activities
- Manufacturing of matching placebo
- Temperature controlled storage of bulk drug substance and (bulk) drug product
- Clinical trial supply
- QP release and full documentation
- QA reviewed batch record documents
- Certificate of conformity/Batch certificate
- TSE/BSE certificate
- Certificate of analysis
LBP testing
Quality control testing for M/WCB, in-process testing, QC release & stability testing and characterization:
- Incoming QC of raw materials
- Assay qualification
- Stability testing
Relying on the strong analytical capabilities of the Eurofins network, we assure we offer the expertise and techniques for a full characterization of your Live Biotherapeutic Products.
Regulatory support
Due to their unique nature, LBPs are subject to regulatory scrutiny. Eurofins CDMO has experience with such projects and work with regulatory specialists in this field to support their application for clinical trials.
To learn more