OUR FACILITIESR&D PLATFORM

From early discovery to CMC Development, totally focused on LBPs
bt_bb_section_bottom_section_coverage_image
https://www.biose.com/wp-content/uploads/2021/01/biose-industrie-adn.jpg

Our dedicated staff and advanced equipment enable us to identify the strain and processes that are the most suitable for your development. The techniques we use are highly dependent on the Live Biotherapeutic Product’s (LBP’s) future purpose.

Nevertheless, for your reference  we’ve included a non-exhaustive list of options for aerobic, anaerobic or GMO strains below:

Strain identification
In vitro characterization, including:
Resistance to biological substances (bile, gastric pH)
Sensitivity to antibiotics, antifungals
Membrane properties characterization
Growth ability on different carbon sources
Adhesion test to human cells (Caco2, HT29, vaginal cell lines…)
Pathogens inhibition
“Biose industrie’s strength is to integrate industrial constraints in the Research and Development process: our R&D and industrial teams work together on a daily basis allowing constant communication between them.”
https://www.biose.com/wp-content/uploads/2021/01/evo-e1495039356431.jpg

This enables a flawless transfer from lab to commercial scale!

Here are a few example of our capabilities:

GMP Cell banking (MCB/WCB)
Process development and optimization:
Culture media and conditions (fermenters from 0.5 to 20 liters working volume)
Concentration/purification
Cryoprotectants
Freeze-drying cycles (freeze-drying capacity from 0.5 to 4 m²)
Grinding / milling development
Stabilities optimization
Finished dosage form development:
Tablets, with specific technology to avoid damaging the bacteria during compression
Powders
Capsules
Liquids
Stability assessments (assessing influence of different parameters):
Temperature (Zone III, IV b) and accelerated stability studies (40+ degrees)
Stability modeling
Process
Packaging, to optimize LBP’s protection