• GMP plasmid as drug substance
  • smGMP plasmid as a starting material
  • E.coli strain screening
  • cGMP production of MCB/WCB
  • Plasmid linearization and clean-up
  • Sterile fill/finish


  • 30L and 300L single-use fermenter
  • Single-use downstream TFF and chromatography purification systems
  • On-site QC with platform assays
  • Facilities and quality systems that support manufacturing from Phase I to commercial
  • Aseptic filling using state-of-the-art, integrated, gloveless robotic isolator with advanced automation provides best-in-class
    sterility assurance
  • Take advantage of our platform process for quick turnaround or use your own process

Process Development /Analytical Development

  • Dedicated process development team
  • Dedicated analytical development team
  • Well-developed tech transfer process, from information transfer to process establishment and process confirmation
  • Process development and optimization

Robust Quality System / Regulatory Support

  • Designed to comply with FDA 21 CFR Part 210/211 and relevant ICH guidelines
  • Type V Drug Master File with FDA that customers can refer to in their IND filing
  • Electronic quality management system to facilitate quality audit and batch record sharing
  • CMC support and consultation from source data sharing to Module 3 write-up to CMC strategy development

Collaborative Program Management

  • Experienced team working continuously to assess and mitigate program risks
  • Regular program meetings to drive program execution and facilitate issue resolution
  • Transparency into our manufacturing processes
  • Proactive communication on program needs and changes
  • Client involvement in activities, with open communication around problem-solving

Let’s Discuss Your Needs