Soter Bio
Soter Bio is a specialized biologics Contract Development and Manufacturing Organization (CDMO) supporting mRNA, cell therapy, gene therapy, and plasmid DNA production. The company provides process development, technology transfer, CMC strategy, validation, and regulatory readiness to help innovators advance therapies from development through commercialization. Soter Bio focuses on translating complex science into robust, scalable, and compliant manufacturing solutions for advanced therapeutic modalities.
Industries
N/A
Soter Bio
Services
Support for process and analytical development for mRNA, cell therapy, gene therapy, and plasmid DNA manufacturing programs, including technical planning and troubleshooting.
Development of comprehensive CMC program strategies, risk registers, and vendor/CDMO selection criteria.
Assessment and preparation for technology transfer, scale-up readiness reviews, and CDMO onboarding.
Validation planning and documentation system development to support compliance, including review cycles and traceability management.
Support for process and analytical development for mRNA, cell therapy, gene therapy, and plasmid DNA manufacturing programs, including technical planning and troubleshooting.
Development of comprehensive CMC program strategies, risk registers, and vendor/CDMO selection criteria.
Assessment and preparation for technology transfer, scale-up readiness reviews, and CDMO onboarding.
Validation planning and documentation system development to support compliance, including review cycles and traceability management.
Expertise Areas
- Advanced biologics CDMO services
- CMC strategy and planning
- Process and analytical development for mRNA, cell therapy, gene therapy, plasmid DNA
- Technology transfer and scale-up
Key Technologies
- mRNA production
- Cell therapy manufacturing
- Gene therapy manufacturing
- Plasmid DNA production