Clinical manufacturing

December 15, 2019
  • 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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