Purolite’s R&D team has produced the largest platform of enzyme carriers and chromatographic media for biotech applications available today. World Pharmaceutical Frontiers speaks to Dr Alessandra Basso, LifeTech manager at Purolite, about the experience behind the success.

Could you give us a bit of company background?

Dr Alessandra Basso: We were founded in 1981 and are now a leading manufacturer of ion exchange media, polymeric adsorbents, catalysts and advanced polymers. Purolite Corporation is also one of the world’s largest developers and manufacturers of high-quality APIs, blood purification polymers, enzyme carriers and chromatographic resins for life sciences.

Headquartered in Pennsylvania, US, the company has ISO-certified manufacturing facilities in the US, China and Romania, and operates dedicated R&D centres in the US, China, Romania, Russia and the UK. Purolite, the only company focused exclusively on resin technology, has 40 sales offices in more than 30 countries.

Can you take us through your pharmaceutical, biopharmaceutical and nutraceutical applications?

Purolite develops resins and adsorbents for use in pilot and production-scale pharmaceutical applications. These include drug carriers for increasing the effectiveness of drug delivery, as well as products for extraction, isolation, purification, immobilisation and biocatalysis of enzymes, hormones, alkaloids, viruses, antibiotics and treatment of fermentation broths.

Purolite resins and adsorbents are used in drug formulations such as APIs and excipients, as well as processing applications such as demineralisation, purification and extraction. All Purolite resins for pharmaceuticals meet the demands of the US, European, British and Japanese pharmacopoeias. Each is manufactured in our cGMP-certified facility, has a drug master file with the US FDA and meets FDA criteria.

What can you tell us about LifeTech and its life science applications?

Our LifeTech product line brings advanced technology to laboratories and biomolecule manufacturing. We provide scientists and biomanufacturers with the highest-quality products to support upstream and downstream bioprocesses. This specialist portfolio of more than 600 products includes the widest platform of enzyme carrier resins for enzyme immobilisation, polymers for solid-phase synthesis of peptides and oligonucleotides, and high-performance chromatographic media for bioseparation and purification. And soon, agarose-based biochromatography resins will expand the LifeTech family of products.

The production of biomolecules for life science expands across many industries, and Purolite is uniquely positioned to support research and production objectives. We have the largest global technical sales network of industry experts, and strong production capability. Our scientists work with respected academic institutions and private and public companies all over the world to develop innovative solutions to complex problems. In recent years, Purolite has brought more products to market than any other resin technology company. Product development, kilogram-to-ton-scale manufacturing, state-of-the-art R&D and production equipment, personalised customer service, and the ability to customise products demanded by the life science market make Purolite the solutions company for reliable new products and technologies.

How has Purolite’s partnership with Codexis enabled the company to develop?

In July 2013, Purolite and Codexis began a collaboration for the development of transaminase enzymes that can speed up new molecule and API development for pharmaceuticals. Codexis engineers enzymes for pharmaceutical, biofuel and chemical production. Its proven technology enables the scale-up and implementation of biocatalytic solutions to meet customer needs for rapid, cost-effective and sustainable process development.

Codexis selected Purolite as a partner for immobilisation because of our experience with support resins and our ability to supply these resins at every scale. Under the collaboration, Codexis has launched a kit of immobilised transaminases as an extension to its Codex screening kits, enabling customers to quickly assess ideas for biocatalytic processes.

Enzymes are immobilised through binding to inert resins, allowing for easier separation from a reaction mixture. Immobilisation often allows the use of these enzymes under different conditions and reuse at a commercial scale, which dramatically improves economics.

We are very proud to partner with Codexis, and successful implementation of these ready-to-use immobilised enzymes for fast screening processes opens the door to new concepts of drug development, where scientists unfamiliar with biocatalytic processes can easily apply immobilised enzymes to screening processes that can speed up molecule and API development.

Purolite will soon expand its selection of immobilised enzymes and we are working with customers to develop customised immobilised enzymes as well as ready-to-use immobilised enzymes. Additional collaborations are in discussion for pharmaceutical and industrial applications.

This article is © Purolite.