Process Development
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Process Development

With a professional process development technical team and focuses on the process development and process scale-up of microbial expression systems, Yaohai Bio-Pharma provides molecular construction, upstream fermentation process development, downstream purification process development, drug product process development, quality specification establishment, analytical method development, transfer and validation, etc. Our diversified technical platform can conduct projects at different stages of R&D to apply the concept of QbD (Quality by Design) throughout process development. On the back of excellent process development capability and abundant project experience, we are committed to providing steady, efficient, economical and fast process development services and achieving stable and reliable production processes.

  • Upstream Process Development
  • Downstream Process Development

With the mature upstream process development platform, Yaohai Bio-Pharma provides services including process development, process amplification, process characterization and process validation. The process development is based on the concept of Quality by Design (QBD), using DoE experimental design methods and process risk management. The robust process is developed and optimized in 16 parallel tanks of 7L which can be successfully scaled up to 100L, 200L, 500L, 1000L and 2001L. Meanwhile, the R&D QA and Registration Compliance Center provides effective supervision and support during the process development, to ensure the authenticity, validity and traceability of development data.

Our upstream process development team has abundant experience in fermentation process development in microbial expression systems, and has successfully delivered various process development projects. The product range includes mainstream biological products such as recombinant proteins, plasmids, mRNA, cytokines, enzymes, allergic reactions, carrier proteins, vaccines, nanobodies, etc.

  • Optimization of medium screening

  • Optimization of fermentation process

  • Purification process scale-up of 7L, 30L/50L, 100L, 200L, 500L, 1000L, 2000L

  • Preparation of CMC application document

Service Advantages
  • Guarantee of professional process development team

  • Rich experience in multi category process development

  • Mature and systematic process development platform

  • Quickly and flexibly adjust the process development strategy based on QbD, DoE and other process design concepts

With the steady downstream process development platform, Yaohai Bio-Pharma provides comprehensive services in purification process development/optimization, process scale-up, process transfer, etc. The QbD concept is applied throughout process development. Combined with first-class advanced experiment instruments such as AKTA, Design of Experiments (DoE) is applied in the process development so as to achieve a stable, efficient and scalable purification process, meet IND application requirements as quickly as possible to save the time and economic costs.

  • Fast filler screening

  • Stability study of intermediates

  • Purification process development and optimization

  • Purification process scale-up of 7L, 30L/50L, 100L, 200L, 500L, 1000L, 2000L

  • Technology transfer

  • Preparation of CMC application document

Service advantages
  • Perfect process development equipment

  • Process development procedure platformization to accelerate IND application

  • Abundant experience in process development projects with high stability

  • The concept of Quality by Design and the method of Design of Experiments to ensure product quality consistency

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