Biotherapeutic Products/Microbiome
The use of Live Biotherapeutic Products (LBP) is rapidly expanding thanks to the central role of the human microbiome as determinant of human health and disease. If you are looking for a partner to introduce your LBP to the market or to clinical trials, we can help.
Eurofins BioPharma Product Testing network of laboratories offers services for the production, preparation, characterization, and safety testing of LBP according to Pharmacopeia (EP, USP). Our team of experts can also support you in customized services related to single- or multiple-strains LBP.
Why Choose Eurofins BioPharma Product Testing?
We offer a single-source complete package of services, from generation of microbial cell bank and related in-process and safety monitoring, to LBP release and product labelling and storage.
Our wide Eurofins network ensures that the expertise and techniques available across the different laboratories can be combined to satisfy our customer requests and always provide you with the best possible service.
Our facilities are fully GMP certified. Next to that, we offer R&D services to develop client methods tailored to your needs.
Services available
LBP production
- Raw Material Testing
- MCB and WCB Generation
- CFU Count and Viability
- Viral Safety
- Impurities and Toxic Agents
- Adventitious Agents
- Contaminants
LBP characterization and ID
- Plate Culture and Microscopy
- Biochemical Assays
- Molecular Genetic Tests: 16S rRNA sequence analysis, multilocus sequence typing (MLST) analysis
- Mass Spectrometry (MALDI-TOF)
- Oligosaccharide Profiling
- Peptide Mapping
Next Generation Sequencing
- Whole Genome Sequencing
- 16S Metagenome Sequencing
Detection of specific microorganisms
- S. aureus
- P. aeruginosa
- E. coli
- S. enterica
- C. albicans
- Clostridia
- Bile-tolerant gram-negative bacteria
Testing available for several other relevant strains based on risk assessment for specific LBP.
Compendial testing
- Appearance, color, clarity, and degree of opalescence
- pH and Osmolality
- Extractable Volume
- Water, Loss on drying, water activity
- CFU Count
- Microbial Contamination AMCC & YMCC
- CCIT
Related services
- Environmental Monitoring
- Spent Media Analyses
- Storage and Stability Testing
- Clinical Labelling
Instrumentation and facilities
- Bruker Microflex MALDI-TOF
- PCR, qPCR, ddPCR
- Biosafety level 2 facility
Contacts
MicrobiomeLBPTesting@bpt.eurofinseu.com
