- Curia has completed a $4 million upgrade of its two aseptic API suites in Valladolid, Spain, aligning with the latest EU GMP Annex 1 standards.
- The investment introduces advanced isolator systems, modernised utilities, and automation to support product safety, compliance, and operational efficiency.
Curia, a global research, development, and manufacturing organisation, has announced the completion of a $4 million investment to upgrade its two API aseptic suites in Valladolid, Spain. The project enhances the site’s compliance with the latest EU GMP Annex 1 standards and reinforces Curia’s commitment to quality, safety, and regulatory excellence.
The upgrades include new isolators, improvements to HVAC systems, automation, sterilisation in place, pharmaceutical panels, and general utilities. The transition to a fully closed system aims to strengthen process and product safety by minimising microbiological contamination risks. The project also includes ergonomic enhancements for operators and additional automatic controls to comply with 21 CFR Part 11 data integrity requirements.
“Quality and compliance are integral to how we operate. The new Annex 1 requirements align with our proactive approach to quality control. We always strive to offer our customers the highest level of assurance when it comes to compliance and our ability to deliver high-quality sterile APIs at scale.”
Philip Macnabb, Chief Executive Officer of Curia
The Valladolid upgrades follow a company-wide review of Curia’s global network to identify improvement opportunities under the new Annex 1 framework. The assessment covered procedures, equipment, utilities, qualifications, and validations to ensure alignment with the latest regulatory expectations.
With more than 20 years of experience in aseptic API processing, Curia’s enhanced capabilities position the company to support complex manufacturing projects worldwide while continuing to deliver reliable and high-quality contract manufacturing services.
