CURIA INVESTS US$4 MLN TO UPGRADE API ASEPTIC FACILITIES IN SPAIN

KUALA LUMPUR, Oct 30 (Bernama) -- Curia Global Inc, a global research, development and manufacturing organisation, has completed a US$4 million investment to upgrade its two active pharmaceutical ingredient (API) aseptic suites in Valladolid, Spain. (US$1=RM4.18)

In a statement, the company said the upgrades align with the latest European Union Good Manufacturing Practice (EU GMP) Annex 1 standards and reaffirm the company’s commitment to regulatory excellence and product quality.

Annex 1 provides guidance on the design and control of facilities, systems and procedures for sterile manufacturing, applying Quality Risk Management principles to prevent microbial, particulate and endotoxin contamination.

Curia Chief Executive Officer, Philip Macnabb said the improvements underscore Curia’s focus on reliability, precision and trust as the company continues to invest ahead of industry trends.

“Quality and compliance are integral to how we operate. The new Annex 1 requirements align with our proactive approach to quality control, and our customers can be assured of our commitment to deliver high-quality sterile APIs at scale,” he said.

The investment supports significant enhancements to the Valladolid site’s infrastructure and technology, including the installation of new isolators and modernisation of HVAC systems, pharmaceutical panels, automation, sterilisation equipment and utilities.

The transition to a fully closed system was the key focus of the upgrade to strengthen process safety and product sterility while improving ergonomic conditions and operator safety. Additional automated controls were also introduced in line with stricter data integrity policies outlined under 21 CFR Part 11.

The Valladolid project followed a global assessment of Curia’s manufacturing network to identify opportunities for improvement in line with Annex 1 standards, covering equipment, utilities, qualifications and validations.

With over two decades of experience in API aseptic processing, Curia said the investment positions the company to handle increasingly complex manufacturing projects while reinforcing its commitment to producing life-changing medicines with uncompromising quality and reliability.

-- BERNAMA