In our cleanrooms, we continue to provide clients with a wide range of sterile manufacturing services. Our innovative facility also houses a self-contained suite for the processing of potent materials with the capability to process a wide range of dosage forms. To demonstrate our scale adaptability, batch sizes can be as small as one unit, up to around 50 kg.
We are licensed for aseptic manufacture of investigational medicinal products and offer you a bespoke design service for isolation technology engineered around the process idea for handling proteins and similar temperature sensitive molecules.
We are licensed for aseptic manufacture of investigational medicinal products and offer you a bespoke design service for isolation technology engineered around the process idea for handling proteins and similar temperature sensitive molecules.
In addition, we can also produce terminally sterilised products on site with product types including ampoules, vials, bags, tubes and syringes. If products are potent, for example cytotoxic or cytostatic, we have a dedicated area with its own air handling and water systems, ideal for the manufacture of such products.
We can offer you the following services for the production of sterile products:
- Ampoule, vial and syringe filling; aseptic and terminally sterilised
- Aseptic liquid and powder filling (including radio-labelled compounds, biologicals and topical products)
- Isolator technology for specialised aseptic filling activities (designed around each client’s individual process needs)
- Autoclaving services
- Filling of biological products
- Cytotoxic formulations and cytostatic products
- IMPD preparation and control
- Scale up of novel dosage forms
- Regulatory advice
- Technical support service
- Formulation services
- Audit of suppliers
- Equipment and process validation
- QP services
- Self-contained suite for the processing of cytotoxic materials