The Industrial Biotechnology Department is dedicated to the production of bioproducts and is organized in two activities:
- The Industrial Development
- The Production of bacterial biomasses.
1. The Industrial Development Team
The Industrial Development team has a strong expertise in:
- Expression and purification of humanized antibodies for research applications.- Development of recombinant protein production processes, focused on protein candidates selected by the Research team.
- Production of clinical batches of recombinant proteins for phase I-II clinical trials.
The expression systems used are either prokaryotic recombinant strains like E. coli or eukaryotic cell lines (i.e. antibody expression).
The Process Development team is designing and optimizing all the steps leading to the active pharmaceutical ingredient (API) with the required purity.
For recombinant proteins produced with a procaryotic expression system the main steps are:
- Fermentation: to generate cultures with a high cell density to boost the productivity,
- Extraction: to separate the biomass from the culture supernatant. For insoluble proteins (inclusion body formation), denaturation and renaturation steps are required,
- Purification: to isolate the protein of interest from impurities.
For the recombinant proteins produced with eucaryotic systems, cultures are carried out in bioreactors and the API is purified from the culture supernatant. Current equipments (bioreactors and purification systems) allow the production of 10-20 g batches of purified proteins.
2. The Production Team
The Production team is committed to the first part of the production process of Ribomunyl™, a registered product of the Pierre Fabre Group. This immunostimulant is made of ribosomal and membrane bacterial fractions. Biomasses of 4 different strains are produced at CIPF by fermentation: Klebsielle pneumoniae, Streptococcus pneumoniae, Streptoccus pyogenes and Haemophilus influenzae.
The Industrial Development and Production facilities are BL2 classified with dedicated equipments. A validation program is settled to ensure a qualification of critical systems (equipments, areas, environment, analytical methods and utilities) and processes traceability. The CIPF Quality Department is dedicated to those activities to comply with the EMEA (European MEdicines Agency) guidelines.
The productions are carried out on a campaign mode (one single strain per week) in 800/600 liters fermenters. More than one hundred fermentation cycles are conducted annually. The biomasses are harvested by continuous flow centrifugation and shipped frozen to Progifarm. This Pierre Fabre facility (established in Gien, France) is in charge of the active components extraction and the API formulation.