Sterile production of non-GMP material for pre-clinical studies
At Coriolis Pharma we offer the service to produce non-GMP material under sterile conditions, e.g. for preclinical studies or stability studies. The advantage for our customers is getting a high quality sterile product, for purposes that require sterility, but not necessarily GMP compliance. Examples are material for preclinical studies (e.g. tox studies) or for indicative stability studies.
- Clean room facility for sterile manufacturing of material for pre-clinical studies (non GMP)
- Hand-filling system and automated systems for all type of vials from 2-50 ml (Bausch & Stroebel for hand filling and automated filling; ROTA for automated filling)
The service for our customers includes:
- preparation of formulations which have been developed in-house or according to the information provided by our customers under class A sterile conditions
- filling of liquid formulations in most vial types by hand filling or automated filling under class A sterile conditions
- preparation of freeze-dried products under sterile conditions