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 food, drug, 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 Healthcare and Life Sciences related activities occur at two ISO 9001:2015 manufacturing facilities located in Victoria, Romania and 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. Purolite Healthcare and Life Sciences operates from our facility in Llantrisant, Wales. The site has been operational since 2008, and functions as the Global R&D Centre of Excellence for both Purolite and Purolite Healthcare and Life Sciences resin products. 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. Our facility in Victoria, Romania has four clean rooms currently in operation. Three of these are FDA-inspected and cGMP compliant for the manufacture of APIs and excipients. The remaining clean room is dedicated solely to the manufacture of Chromalite and Lifetech resin products.
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 three 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.
This facility, directly adjacent to our R&D Centre of Excellence, is capable of supplying 100000L of agarose resin per annum, with base bead batch sizes of 600L. This is equal to one-third of today’s total global demand for agarose resins within the biologics market. In 2022, Purolite manufacturing capacity will be capable of meeting 100% of global demand.
Lifetech and Chromalite
Products are manufactured at both UK and Romania-based facilities, which are fully certified under ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. To reduce the risk of unexpected emergencies or disasters affecting our ability to manufacture and deliver product to our customers, manufacturing processes are expressly designed to facilitate production at an alternative manufacturing site should any Purolite® facility be adversely affected in any way.
Lifetech ECR and immobilized enzyme products are manufactured via traditional suspension polymerization techniques and activation chemistries at each production scale depending on volume required. At our Romanian production site, Clean Room 4 (CR4) is fully equipped with a wet screener, a reactor for resin functionalization and equipment for the drying and packing of products in a controlled environment. The processing capacity of CR4 is greater than 1 ton of resin per batch. Such quantities are achieved across three pilot plant units equipped with 20L, 50L, 100L and 200L reactors respectively, as well as ancillary equipment. Together, these enable efficient generation of products of the highest quality.
Chromalite chromatography products are produced using a Purolite®-patented jetting technology, developed by our UK-based R&D team. These products are manufactured both in our UK-based pilot facility and at full production scale in Romania. Our highly-qualified scientists have the technical expertise, experience and equipment to produce uniform bead gels and macroporous products in the range of 15 - 1000 μm in diameter, with uniformity coefficients as low as 1.1. This narrow particle size distribution is vital for effective chromatographic purification. The total capacity of our UK site is greater than 200 kg of resin per batch.
Purolite Healthcare and Life Sciences 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.
For Lifetech and Chromalite products, the existing production capabilities in both the UK and Romania sites allow an immediate alternative manufacturing location to step in should one or the other Purolite facilities be adversely affected
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. As such, both UK and Romania-based facilities are ISO-accredited, and our Romania-based site is FDA-inspected and approved for production of active pharmaceutical ingredients. 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 Life Sciences 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.