CMC Expertise and State-of-the-Art Manufacturing
Elpiscience has a seasoned CMC team and state-of-the-art manufacturing facility in Suzhou, China, which extend our integrated capabilities from antibody discovery to clinical-scale manufacturing.
Process Development

Process Development (PD) is a bridge for translating molecules from the research to clinical stage of development. Our translational research process is designed to be highly capital and time efficient. At PD department, the product quality by design is assured based on rigorous scientific methods and principles combined with risk management tools that are applied throughout the process understanding, process improvement, process validation, continuous verification from the economical perspective.  

The PD department at Elpiscience houses the function group of Cell Line Development, Cell Culture, Purification, Formulation Development, and Analytical Sciences.

  • Cell Line Development

    High titer cell line (proprietary expression vector, gene transfer) construction platform

    High-throughput cell line screening process

  • Cell Culture Process Development

    Media optimization development platform

    Scaled down model for process characterization

    Perfusion cell culture process development

  • Purification Development

    High-throughput technology platform

    Continuous manufacturing technology

Technical Operations

Elpiscience has established state-of-the-art manufacturing in Suzhou, China equipped with a full-functional quality control lab, warehouse and clinical-scale manufacturing. Our operations are designed and operated in compliance with major international standards, including NMPA, FDA, and EMA cGMP standards. Elpiscience’s manufacturing facility consists of a pilot plant for 50L/250L scale-up and cGMP suites for clinical supply at 1000L scales for Phase 1/2 clinical studies.