Comprehensive manufacturing services
Our services include everything needed to take your program from preclinical research to clinical trials and finally to commercialization
Our full-service cGMP plasmid manufacturing services include:
- Highly trained process development scientists and manufacturing engineers
- Inbound technology transfer and seamless scale-up
- Robust process optimization to achieve desired critical quality attributes while maximizing yield
- Manufacturing in segregated, validated clean rooms with 24/7 monitoring
- Defined and validated critical process parameters (temperatures, times, agitation rates, etc.)
- Full-scale engineering and process validation capabilities to enable cGMP production
- Procurement and management of cGMP-grade materials sourced from audited and qualified suppliers
- Client-specific batch record and documentation with Certificate of Analysis upon full quality release
- Generation, characterization, and storage of master and working cell banks
- Full suite of analytical testing capabilities, including assay qualification and validation