Facilities
More than 10,000 m² of production area
We produce research and GMP grade chemical and biological components in dedicated inspected laboratories, clean rooms and GMP areas.
Constant internal oversight combined with frequent audits by customers and authorities, allows us to operate in highly-efficient and state-of-the-art facilities.
GMP Facilities for biomanufacturing
Our GMP manufacturing facilities are AFMPS and FDA inspected and are accredited for the production of clinical trial and commercial material.
We thoroughly check raw materials, area environment and production samples to eliminate any risk of contamination.
We have multiple GMP suites to perform fermentation, purification and filtration:
- 4 GMP Fermentation suites (80 L, 150 L, 500 L, 2200 L fermentors)
- 3 GMP Purification suites
- 1 GMP 0.2µm Filtration suite
We have dedicated areas for process transfer and development. All projects are developed and optimized in these areas before being transferred to the GMP fermentation zones.
ISO7 and ISO8 Certified Cleanrooms
Our state-of-the-art cleanroom facilities meet Class 100,000 (ISO8) and Class 10,000 (ISO7) standards with Class 100 (ISO5) working zones. Access to cleanrooms is authorized to qualified staff.
CRM Peptides, Diagnostic, Pre-clinical, clinical oligonucleotides and IVT RNA are manufactured under a controlled environment to prevent cross-contamination.
Custom Assay Preparation
Our fully automated workstation and filling line allow us to prepare and deliver custom molecular assay in thermosealed plates, strips or tubes.
The production process takes place in ISO8 facility with full control of contamination risk.