Potent material handling: Up to OEB class 5
Sterile injectable products make up a large proportion of marketed pharmaceuticals and play a key role in new drug developments. We offer service for all common parenteral formulations covering intravenous, subcutaneous and intra-muscular application, or development of aseptic liquids or emulsions for ophthalmic indications.
Our facilities and equipment are setup to handle demanding cooling chains required for fill finish of sensible products such as mRNA or DNA based formulations.
We can provide scalable solution for cytotoxic and non-cytotoxic products following cGMP requirements (isolator technology for cytotoxic and non-cytotoxic formulations in vials, as well as open RABS for non-cytotoxic vials).
- 100g scale up to 200L commercial batch size for cytotoxic products
- 100g scale up to 1000L commercial batch size for non-cytotoxic products
We are setup to implement and perform all microbiological testing in house.
Our formulation and fill finish offer covers
- Small molecules
- Large molecules (such as Vaccines, mAbs, Enzymes)
Besides all conventional molecules we can handle
- High potent APIs
- Cytotoxic & cytostatic APIs