Security of supply statementAs 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® Life Sciences products

• Chromalite® polymeric resins for adsorption, ion-exchange, solid-phase extraction, and analytical and preparative chromatography

• Lifetech™ ECR resins for covalent, adsorption or ionic enzyme immobilization and ready-to-use immobilized enzymes

• Praesto® agarose-based affinity, ion exchange and non-functionalized resins for monoclonal antibody and protein purification

Purolite® Life Sciences supports R&D and production-scale applications in pharmaceuticals, food production, bioprocessing, fine chemical and other markets. Our product portfolio consists ofhigh-quality resins for enzyme immobilization and chromatographic separations, and ready-to-use immobilized enzymes for biocatalysis. Purolite® resins and adsorbents are also used in drugformulations as active pharmaceutical ingredients (APIs) and excipients.

Purolite® has a team of world-class researchers and scientists who develop novel, high-demandand customized resin products. Collaborations with other leading industry organizations andresearch institutes across the globe enable us to consistently produce the most innovative andsophisticated resin technologies.

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Security of Supply

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Secure UK and EU-based resin manufacturePurolite® takes a risk-based approach to supply management. All Life Sciences related activities occur at two ISO 9001:2015manufacturing facilities located in Victoria, Romania and Llantrisant, Wales, UK. This includes R&D, manufacturing, customerapplications, quality and regulatory affairs, as well as commercial operations.

Purolite® Life Sciences operates from our facility in Llantrisant, Wales. The site has been operational since 2008, and functions asthe Global R&D Centre of Excellence for both Purolite® and Purolite® Life Sciences resin products. The R&D Centre of Excellence hasbenefited from continual investments to support laboratory expansion, state-of-the-art equipment installation and recruitment. Thiscommitment 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 of Life Sciences resin products tobe 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 compliantfor the manufacture of APIs and excipients. The remaining clean room is dedicated solely to the manufacture of Chromalite® andLifetech™ Life Sciences resin products.

Manufacturing sites | Lifetech™ and Chromalite®

Purolite® 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™

Lifetech™ ECR and immobilized enzyme products are manufactured via traditional suspension polymerization techniques and activationchemistries 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®

Chromalite® chromatography products are produced using a Purolite®-patented jetting technology, developed by our UK-based R&Dteam. These products are manufactured both in our UK-based pilot facility and at full production scale in Romania. Our highly-qualifiedscientists have the technical expertise, experience and equipment to produce uniform bead gels and macroporous products in the rangeof 15 - 1000 μm in diameter, with uniformity coefficients as low as 1.1. This narrow particle size distribution is vital for effectivechromatographic purification. The total capacity of our UK site is greater than 200 kg of resin per batch.

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Manufacturing sites | Praesto® The manufacture of Praesto® agarose-based resins for bioprocessing occurs solely 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.

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:

Pilot facility

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.

Jetting facility

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.

Full-scale manufacturing facility

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.

Continuity of supply and disaster recoveryPurolite® 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 LifetechTM, Chromalite® and Praesto® resins to our customers, Purolite® has taken robust steps to mitigate business risk in the manufacture of these critical resin products.

Lifetech™ & Chromalite®

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.

Praesto®

Should Praesto® production facilities in the UK 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 beimplemented at our facility in Romania using an identical, modular design of the UK-based production facility.

Raw materialsAs part of our security of supply commitment, raw material suppliers are qualified from leading manufacturers and are part of a network supplier program. Raw materials are subjected to our quality control system to ensure consistency. Additionally, all suppliers of raw materials are audited by our dedicated in-house Quality team using a risk-based approach. Selection of raw materials is centralized at global level through a dedicated Purchasing department. Their role is to ensure that a consistently high quality & grade of raw materials is available across all global manufacturing and R&D facilities. This approach ensures final product quality remains consistently high, irrespective of its site of manufacture.

Quality assurance and quality controlQuality 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.

Inventory and distribution Raw materials and high-demand products are stocked in strategic global locations, and inventoried to ensure consistent availability. This distribution network ensures that products are available to our customers with minimal lead times. Regarding raw materials, an advanced materials management system in conjunction with manufacturing planning tools ensure that supplies are continually available for the efficient production of new products.

Our sales, technical and customer service teams work hand-in-hand to ensure customer supply is uninterrupted. Purolite® has agreements with freight forwarders and multiple land and air carriers to reduce bottlenecks, ensure timely delivery of materials, and oversee shipments to ensure they are compliant with all international export regulations.

CommitmentTo minimize potential impact to our customers, Purolite® continually invests in facilities, processes and equipment to ensure that our locations, products and services – as well as those of our suppliers – are unaffected by disasters, emergencies and potential incidents.

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