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BioManufacturing
GMP Antibody fragments
We have experience in the production of numerous fragment formats (VHH, scFv, Fab, diabody, and bispecific tandem scFv) in E.coli or P.pastoris.
We also have developed expression systems that allow for high copy number strains to be developed using P.pastoris providing stable cell lines that are easy to characterize with improved yields.
GMP Manufacturing facilities
- 4 GMP Fermentation suites (80-2200L)
- 3 GMP Purification suites
- 1 GMP 0.2 μm filtration suite
- Classified clean rooms
- Full traceability
- QA and QP release
Regulatory
All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.