Curia Invests $4 Million to Enhance Sterile API Manufacturing
Curia has completed a $4 million upgrade to its sterile API manufacturing suites in Valladolid, Spain, aligning with EU GMP Annex 1 standards to enhance product quality, safety, and regulatory compliance.
Curia, a global contract research, development, and manufacturing organization (CRDMO), announced the completion of a $4 million investment to upgrade its two API aseptic suites in Valladolid, Spain. The investment aligns with the latest EU GMP Annex 1 standards and reinforces Curia’s longstanding commitment to regulatory excellence and product quality. Annex 1 provides general guidance for the design and control of facilities, equipment, systems, and procedures used for the manufacture of all sterile products, applying the principles of Quality Risk Management (QRM) to prevent microbial, particulate, and endotoxin contamination in the final product.
The enhancements support upgrades to Valladolid’s infrastructure and technology. Curia used innovative tools to take advantage of new possibilities derived from the application of an enhanced process understanding. The bulk of the investment was dedicated to updating the site’s equipment, including the installation of new isolators, along with modernizations to HVAC, pharmaceutical panels, automation, sterilization in place and general utilities. Transitioning to a fully closed system was the primary driver of these upgrades, with the goal of supporting process and product safety and preventing microbiological contamination at every step of production. Additionally, ergonomic improvements for operators were key to increasing operational safety, along with the implementation of additional automatic controls in line with stricter data integrity policies, as described in 21 CFR Part 11.
“Quality and compliance are integral to how we operate,” said Philip Macnabb, CEO of Curia. “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. Customers depend on us for reliability, precision and trust. With these improvements at Valladolid, they can feel confident that we will continue to invest ahead of industry trends as we partner with them to bring their products to market.”
The updates at Valladolid followed a company-wide evaluation across Curia’s global network to identify opportunities for improvement related to new Annex 1 requirements. The assessment examined procedures, equipment, utilities, qualifications, and validations to create solutions tailored to each site and to address any areas for optimization.
Curia’s global API aseptic processing manufacturing network has served a broad portfolio of customers worldwide for more than 20 years. This investment positions the company to support increasingly complex manufacturing projects, while strengthening its commitment to delivering life-changing medicines with uncompromising quality and reliability.
