Flexibility and efficiency combined with regulatory compliance. Right first time. More than 10 years of experience in clinical manufacturing within the European market among others.
- Flexibility and efficiency were the key concepts for designing Liof Pharma CDMO’s State-of-the-art filling facilities and equipment.
- Our processes are specially designed for easy format changing resulting highly effective for small batches
- We work with disposable equipment and have a flexible set up to handle multiple formats of vials for injection and plastic bottles (eye drop type), and to ensure fast and flexible technical transfers, without the need for extensive cleaning validations.
- Because of our size and flexible set-up, we have a low overhead structure, can start quickly, and offer very competitive pricing.
- Clinical manufacturing (Preclinical, Phase I, Phase II, Phase III) service is offered using Non cGMP / cGMP conditions, automated filling processes matching all the customer needs.
- Manufacturing steps include sterile filtration, preparation of primary packaging materials (e.g., cleaning, sterilization), preparation of the formula and lyophilization if required – primarily biologics such as peptides, monoclonal antibodies, other proteins, RNA and adenovirus.
- We have the experience to provide regulatory recommendations to comply with the expectances for the CMC sections of the regulatory submissions.
Extensive knowledge in commercial manufacturing of sensitive and high-value biologic drugs and aseptic processing.
- Our aseptic filling technologies meeting the latest state-of-the-art are among the most advanced in the medicinal product contract manufacturing industry incorporating HVAC automatic control, continuous particle monitoring, automatic cleaning, sterilization and other automatic processes and testing.
- Once the product is filled and finished, we perfom 100% inspection of the drug product cotainers prior to labelling.