Mammalian GMP Overview
Curia has facilities that can provide GMP manufacturing services. While they are generally served as part of our Integrated Solution packages, we can provide them as individual services.
The Curia Hopkinton, MA facility is ISO 13485:2016 certified and provides GMP manufacturing of mRNA, antibodies, proteins, and vaccines and collaborates with Curia Hayward, CA for process development.
Curia Bulk Drug Substance mRNA Manufacturing Capabilities
- GMP compliant, single use equipment
- Cell-free mRNA manufacturing
- Large scale production up to 8-80 grams/batch
- ISO7 suite
- Expertise in self-amplifying mRNA production
- Onsite analytics for in-process testing and batch release
Antibody & Protein Therapeutic Development and cGMP Manufacturing
- Single use equipment
- 200, 500, and 2000 liter SUBs
- ISO7 post-viral and fill/finish suite
- Onsite analytics for in-process testing and batch release
- Total timeline ~18 months for phrase 1 drug substance
Drug Product Formulation Development and Manufacturing in Camarillo, Glasgow
- EU Grade A Environment
- Vial size: 2-30cc
- Fill Volume: 0.2-32 mL
- Max batch size:
- Liquid: 20,000 units
- Lyophilized: 1200-5,000 (2 cc to 20 cc)
- Onsite analytics for in-process testing and batch release
Are you looking to accelerate your program or simply want to learn more about our services? If you would like to speak to a member of our expert team and arrange for a tour of our cGMP facility in Hopkinton, MA, please contact Curia here.