Extensive knowledge manufacturing sensitive, high-value biologics and aseptic processing.
Our aseptic filling technologies and lyophilization methods meeting the latest state-of-the-art are among the most advanced in the medicinal product and medical devices 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 perform 100% inspection of the drug product containers prior to labelling.
Flexibility and efficiency were the key concepts for designing our State-of-the-art filling facilities and equipment.
Our processes are specially designed for easy format changing resulting highly effective for small batches production.
We work with disposable equipment and have a flexible set up to handle multiple vial formats 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 NoncGMP/cGMP, semiautomated/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 proteins and monoclonal antibodies.
We have the experience to provide regulatory recommendations to comply with the expectances for the CMC sections of the regulatory submissions.
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