Visite de site
1 visite de laboratoire au choix parmi Charles River / Eurofins BPT
Visite sous réserve de disponibilité, le nombre de places étant limité.
Charles River
Tour description
- Automation of endotoxin assays through robotization and implementation of a trend monitoring tool to track and control results. Objective: fewer retests and continuous process verification thanks to a predictive tool to anticipate contamination. (duration 30 minutes)
- Optimization of in-process and final release testing through a rapid microbial detection method in compliance with regulatory authorities. Objective: Refine your control strategy by obtaining faster, objective results via automated reading; reduce production and release times. (30 minutes)
- Microbial identification laboratory: Use of an automated platform to track a sample from intake to data analysis. Objective: a paperless process to help you control your environmental monitoring (trend monitoring and CCS implementation) (30 minutes)
- Tour of our new endotoxin laboratory. Objective: a laboratory design based on a risk-based approach and presentation of our various analytical methods (30 minutes)
Eurofins
Tour description
Visit to the new Eurofins Biopharma Product Testing Biologics site in Lentilly. This site is a mixed pharmaceutical establishment authorized by ANSM and ANSES for Quality Control of biotherapeutic drugs (including MTIs).
This visit will enable you to discover the quality control laboratory for human and veterinary biological drugs under GMP conditions.
After a presentation of the site's organization, the tour will take in the premises designed in line with modern pharmaceutical standards, and the services and innovations offered in areas such as: Biobanking, non-sterile microbiology, sterile microbiology, micro-organism identification, chemistry, biochemistry, molecular biology and cell culture.
The site is multidisciplinary to offer a “one stop shop” concept to our customers, with the following activities:
- Biobanking: Conservation of cell lines (prokaryotes, eukaryotes) and biological products at negative temperatures (-20°C, -80°C, <-150°C). PSL, MSL, WSL.
- Non-sterile microbiology: Bioburden (Pharmacopoeia method), Low-Bioburden, Endotoxins (rFC method), detection of specified microorganisms. Enumeration of microorganisms in biotherapeutic products.
- Sterile microbiology: sterility testing in cleanroom isolators, development, validation, routin
- Bacterial and fungal identification: phenotypic identification (MALDI-TOF methods), molecular identification by comparative sequencing (Eurofins unilocus and multilocus methods).
- Chemistry-Biochemistry: Appearance, pH, visible and sub-visible particles, osmolality, residual humidity, identity, purity, activity of biological products, HCP, HCDNA, Peptide mapping, Glycan analysis, enzymatic activities.
- Molecular Biology: Detection, identification and characterization of biological products or contaminants by PCR, qPCR, RT-qPCR, ddPCR, Sanger sequencing, NGS sequencing, Bioinformatics.
- Cell culture: Assay tests.