At Probionov, we know that your future Market Authorization dossier will include information gathered since the first day of development at an R&D level. For this reason, our R&D department applies GMP rules for drug development in all its programs.
Transfer from R&D to full-scale production is a critical step. To overcome it successfully, we have an added value: our R&D team works daily with our branch, a pharmaceutical laboratory producing GMP probiotics at the industrial level. This integration allows us to propose a full service, from R&D to finished products, within the same organisation.
We can provide all our R&D expertise in microbiology, probiotics and microbiota products, for missions such as:
- Identification of new strains based on samples or from our strain base, genotypic and phenotypic characterization, and evaluation of their performance for specifics therapeutic applications.
- Analytical methods development
- Formulations development (Product definitions: formulation, regulatory stat, etc.)
- Strain stabilization
- Galenic development
- Scale up
- Stability study (ICH recommendation)
- Clinical batches production
- Regulatory expertise
- Managing clinical trials
- Writing of scientific and regulatory files, publications, etc.
Our internal R&D department is equipped with state of the art technology for:
- Microbiology: automatic serial diluter, plate & colony counter, flow cytometry, anaerobic chamber, Class II biosafety cabinets, bacterial and cell culture, etc.
- Biochemistry: HPLC, UPLC, spectrophotometer
- Molecular biology: quantitative and qualitative PCR (rep-PCR, real-time PCR, etc.), DNA chip, genome annotation (safety analyze, research of genes of interest) ….
- Production scale-up (fermentation, freeze-drying, mixing and packaging) from the laboratory (fermenter of 500 ml) to the pilot plant (2 L to 30 L) and to industrial production
Our internal capabilities are complemented by a network of universities, particularly in immunology, galenic, bioinformatics and animal studies (Auvergne, Paris, Bordeaux, INRA).
For R&D projects you can contact our R&D deparmtent at: firstname.lastname@example.org