Curia Global, a leading global research, development and manufacturing organisation, announces the completion of a $4m investment to upgrade its two API aseptic suites in Valladolid, Spain.
The enhancements support upgrades to Valladolid’s infrastructure and technology. Curia utilised innovative tools to capitalise on new opportunities arising 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 modernisations to HVAC, pharmaceutical panels, automation, sterilisation-in-place and general utilities.
Transitioning to a fully closed system was the primary driver of these upgrades to support process and product safety and prevent 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 optimisation.
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.