Services
- 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
Capabilities
- 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
