Formulation Process
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Drug Product Process Development

Yaohai Bio-Pharma has a mature service platform for drug product development to provide customers with product formulation and process development services for different types of biological products (recombinant proteins, monoclonal antibodies, nanobodies, etc.). Comprehensive equipment and related testing instruments for drug product process development facilitate the development of various dosage forms such as macromolecule pre-filled injections, lyophilized powder for injection, eye drops, oral solutions, inhalants, etc. In combination with the characteristics of macromolecular drugs, quickly screen suitable formulations to support customers with one-stop R&D service for biological drug IND/BLA application.

  • Development of macromolecule drug formulation
  • Development and optimization of lyophilization process
  • Long-term and accelerated stability study
  • Drug product process development
  • Quality assessment of raw materials and excipients
  • Process scale-up and technology transfer

Independent experimental areas are in place for drug product formulation and process development. The laboratory is equipped with various instruments and equipment required. For example, Q-PCR used for selecting the best drug product formulation through high-throughput screening; mainstream domestic lyophilization machines of multiple models used for lyophilization process development and optimization under various conditions.

Our drug product process development team acquires abundant project experience in the development of liquid preparations (recombinant proteins, monoclonal antibodies, vaccines, etc.), lyophilization preparations, etc., applying the concept of Quality by Design (QbD) throughout process development.

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