Physicochemical Analysis of Plasmid & mRNA

The analytical platform for plasmid and mRNA empowers clients' projects, providing strong analytical support throughout the entire lifecycle of plasmid, mRNA, and LNP-mRNA products, from process development to manufacturing.

The analytical capabilities encompass method development, method transfer, method validation, product quality attribute studies, product release, stability studies, etc. providing strong technical support to accelerate the progression of projects and enabling the regulatory submissions in a short time.

Scope of Services:
Plasmid and mRNA Analytical Platform
  • Analytical Methodology

    Analytical method development/method transfer/method qualification/method validation

  • CMC Development Support

    Product quality verification, supporting process development and process validation

  • Product Release/Stability Studies

    IPC testing during process development, release testing, long-term/accelerated/stress stability studies

  • Product Quality Attributes Study

    Structural characterization, impurity analysis, in vitro expression, etc.

Analytical Ability:
Key Equipment:
  • Agilent5200 Fragment Analyzer
  • Waters Arc HPLC
  • Agilent 1290 UHPLC
  • Malvern Zetasizer Pro Nanoparticle Zeta Potential Analyzer