RetD-US

NEW-LOGOS-BLEU-OCTOGONE_(R&D)

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.

Our expertise

We can provide all our R&D expertise in microbiology, probiotics and microbiota products, for missions such as:

  • _MG_2099_1Identification 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 technology

_MG_3939 (R&D)

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: contact@probionov.com

Top