GMP clinical batches
Live biotherapeutic product (verum + placebo) GMP manufacturing
At this stage, key word is “flexibity”: depending on your current phase of development, we can adapt our manufacturing capacities (and corresponding costs) to your needs:
- 20 liters fermentor, for pre-clinical models
- 300 liters fermentor, for phase II or small phase III
- 3500 liters for phase III with large population.
biose® industrie has a drug GMP accreditation for the manufacturing of clinical materials, given by French health authorities (ANSM).
We offer a full service operation including API creation, finished product manufacturing (tablet, capsules, liquids) and labelling of investigational products.
Last but not least: LBP powder is not always white and sweet like maltodextrine: we develop and manufacture placebos formulations that perfectly mimic the organoleptic characteristics of you Verum. With such know-how, we can ensure absolute double blind conditions.