Resins for mAb Purification

Monoclonal antibody (mAb) therapeutics are widely-used to treat ailments including cancer, rheumatoid arthritis, dementia and diabetes. Agarose-based chromatography resins are a vital technology for biopharmaceutical developers to obtain optimal purity in downstream mAb bioprocessing.

The Praesto® range of agarose-based Protein A and Ion Exchange chromatography resins are industry-leading products, currently implemented into several hundred ongoing mAb screening projects and clinical trials globally. A key factor in this is our patented 'Jetting' technology offering enhanced performance characteristics over commercially-available alternatives. 

Why Purolite?

  • The only provider of uniform particle sized Protein A and SP / Q-functionalized agarose resins
     
  • Secure, global supply network
     
  • 30 years of regulatory experience
     
  • Lab to process-scale manufacturing capabilities
     
  • Pharmaceutical grade, high-purity resins
     
  • Personalized technical support to work hand-in-hand with your team

Security of Supply

Ensuring reliable availability of resins is vital to customers and is of paramount importance to Purolite. As a leading supplier of resin media to the world’s most regulated industries, we recognise that Purolite’s resins are critical purification products. As such Purolite has a real-world security-of-supply system in place to support your process requirements for business continuity. 

For our Praesto range, we operate one of the largest agarose resin manufacturing sites in the world, located in South Wales, UK. (Learn more...)

Regulatory Support

Purolite is a global leader in resin technology, and one of the world’s largest developers and manufacturers of high-quality chromatographic resins, enzyme carriers, ion exchange resins, APIs, adsorbents and specialty resins.

All Purolite Life Sciences products are of premium quality and are produced in our ISO-certified production facilities in the UK, Romania, China and the USA.

For over 35 years, Purolite has supplied specialty resin technology to industries within complex regulatory environments including biotechnology, pharmaceutical, food, fine chemical and electric power generation.

Purolite complies with required national and international regulations, as well as many voluntary specialty certifications. These include: • Part II of the EU GMP Guide • US FDA Current Good Manufacturing Practice (CGMP) regulations • US FDA CFR - Code of Federal Regulations including Title 21 • GMO/TSE/BSE free • ResAP(2004)3 • NSF/ANSI 61/WRAS standards • REACH regulations • ISO 9001:2015 quality system specifications, • ISO 14001:2015 Environmental Management System requirements • OHSAS18001:2007 • RoHS Directive 2011/65/EU • Halal and Kosher requirements

We also hold Drug Master Files with the US FDA, Japan, Canada and EU.

Monoclonal Antibodies Products by Application