Supply of preclinical Tox-material
Coriolis is the expert in formulation development for liquid and lyophilized drug products. During pre-clinical development phases, non-GMP drug product batches are often required for e.g., toxicological studies (TOX batches) or indicative stability studies. Coriolis offers the manufacturing of liquid and lyophilized products in a large variety of formats and batch sizes for drug products up to biosafety level S2
Liquid drug product manufacturing
In our GRP regulated facilities, we utilize modern automated filling equipment (Flexicon FCP50 including LAF by Franz Ziel, up to BSL1/S1)) for all common vial formats covering a broad range of batch sizes from a few dozen to several thousand. For special container formats (such as prefilled syringes, safe-lock tubes, cryotubes), for small batches (e.g., for reference materials) and products up to BSL2 / S2, we also offer flexible semi-automated or manual filling solutions.
Lyophilized drug product manufacturing
Coriolis has a strong expertise in developing lyophilization processes and perform scale-up and robustness testing. Our 400 m2 lyophilization development center includes a range of modern freeze-dryers from lab to production scale, equipped with comprehensive process analytical tools. We offer manufacturing of lyophilized drug products up to BSL2 / S2 in all common vial formats and prefilled syringes, covering a broad range of batch sizes from a few dozen to several thousand (freeze-dryers from 0.5 to 6 m2 shelf area).
Maximum batch sizes
Liquid drug products 2R – 15,000 vials/day
6R – 8,000 vials/day
10R – 8,000 vials/day
20R – 4,000 vials/day
25R – 4,000 vials/day | Lyophilized drug products 2R – 19,000 vials/cycle
6R – 10,000 vials/cycle
10R – 8,000 vials/cycle
20R – 5,000 vials/cycle
25R – 4,000 vials/cycle |
