Supply of preclinical Tox-material

supply_preclinical_material

 Production of non-GMP batches under aseptic conditions

Aseptic filling of tox-materials and non-GMP drug products (lyo & liquid)

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) 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) and for small batches (e.g., for reference materials), 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 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

Drug product analytics and stability testing

As a development company with a strong focus on analytical characterization of biopharmaceuticals, we offer a large portfolio of specialized analytical techniques. Based on the project requirements, we offer a tailored analytical testing regiment for your liquid or lyophilized drug product batch – including a customized batch manufacturing record. We also perform stability and forced degradation studies under virtually any storage condition or simulating a large variety of stress conditions under R&D and GMP.

Contact our experts today and find out how we can support your drug development program with the supply of preclinical material.
 

Contact us

Contact us

For enquiries related to supply of preclinical material please contact Dr. Stefan Heindl

Dr. Stefan Heindl