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.
Peptides Production Laboratories
Located at AnaSpec, our fully-owned subsidiary (Fremont, US), our peptide synthesis laboratories are equipped with state of the art synthesizers which allow the production of grams of peptides up to 60 amino acids.
Thanks to our peptides experts we can easily manage the synthesis of complex peptides such as cyclic or constrained peptides.
Dedicated cleanrooms allow for the production of IVD GMP grade peptides.
Oligonucleotides Synthesis Areas
Our Oligonucleotide manufacturing facilities are located in Belgium.
We deliver research, diagnostic and therapeutic grade oligonucleotides from µg to grams.
We have multiple synthesizers operating in parallel to ensure continuous production of standard and highly modified nucleic acid sequences. Our chemists are experts in complex oligo synthesis such as: siRNA, Double Dye Probes and long oligos.
All products are quality controlled under specific environments according to their grade (Research, diagnostic, therapeutic). We have multiple Quality Control zones in our buildings to check the raw materials, the delivered products and samples during the production process.