Accelerate your biologic drug development with Praesto®
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As a leading supplier of resin media to the world’s most regulated industries, ensuring reliable availability of resins is vital to our customers and of paramount importance to Purolite. Purolite is a critical supplier to the pharmaceutical, food, medical, water and power industries, so has a real-world, robust security-of-supply system in place to support your process requirements for business continuity.
Purolite takes a risk-based approach to supply management. At present, all Bioprocessing-related manufacturing activities occur at ISO 9001:2015 accredited manufacturing facilities located in Llantrisant, Wales, UK, with a further facility in the USA scheduled for completion in 2022. This includes R&D, manufacturing, customer applications, quality and regulatory affairs, as well as commercial operations. The Purolite Bioprocessing Division operates from our facility in Llantrisant, Wales. The site has been operational since 2008, and functions as our Global R&D Centre of Excellence. The R&D Centre of Excellence has benefited from continual investments to support laboratory expansion, state-of-the-art equipment installation and recruitment. This commitment to innovation has placed the facility at the forefront of resin bead technology globally. Further investments into manufacturing capabilities at this facility have enabled larger quantities to be efficiently produced to meet industry demand. As such, products are currently being manufactured there in quantities from laboratory scale through to commercial manufacturing volumes.
The manufacture of Praesto agarose-based resins for bioprocessing occurs at our UK-based facilities. This includes R&D, manufacturing, a dedicated customer applications team, and column packing demonstration suite, together with all commercial operations. An additional manufacturing facility, located in the USA, will be operational in 2022.
Purolite has two independent, ISO-certified production lines in two physically separate buildings at our Llantrisant, UK site, dedicated to production of agarose base matrix (beads). These comprise:
Opened in 2014 and in continual 7-day operation since 2017 due to high customer demand, this facility has an annual capacity of 3500L of functionalized agarose resins.
Dedicated specifically to production of our innovative, uniform agarose beads, this patented, solvent-free and continuous manufacturing allows for the precise control of agarose bead sizes of 20 μm and above. In 2022, Purolite manufacturing capacity will be capable of meeting 100% of global demand.
Purolite Bioprocessing products are manufactured and stored in global locations which are considered low-risk for natural, political, economic, social or technological disasters. However, in the unlikely event of a critical occurrence, Purolite work closely with affected customers to communicate details about said event, advise on any product shortages, work with local and national authorities for business recovery and communicate all necessary notifications regarding either supplier or product changes. To ensure business continuity and the uninterrupted supply of Praesto resins to our customers, Purolite has taken robust steps to mitigate business risk in the manufacture of these critical resin products.
Should Praesto production facilities be adversely affected to a level that would disrupt business operations, Purolite has designed manufacturing processes that facilitate rapid deployment at a different location. In this event, a rebuild plan would be implemented at facilities in the UK, USA or Romania using an identical, modular design of the affected production facility.
Quality control at Purolite is an integral part of our security of supply commitment, and Purolite follows a well-established and defined quality assurance process. Our QA system ensures that each manufacturing process is globally controlled, enabling production to be transferred between manufacturing sites with minimal impact on customer supply. Our continuous manufacturing commitment is to operate exceptional manufacturing processes which result in exceptional products, regardless of their place of manufacture. Quality control of Bioprocessing products is performed using test methods also validated and approved at a global level. Following approval and validation, these methods are also implemented across all global manufacturing facilities to ensure the same high level of quality. Purolite documentation is continually monitored, reviewed and strictly controlled within our Quality Management System. This system functions to contain and control essential documentation such as calibration certificates, Purolite International Test Methods (PITMs), product Certificates of Analysis, standard operating procedures and internal product specifications.
Anion Exchange Chromatography - Agarose Base
Cation Exchange Chromatography - Agarose Base
Protein A Affinity Chromatography