Protein A affinity chromatography continues to be the preferred method of choice for the purification of antibodies, due to its very high selectivity and robust resin performance over repeated purification cycles.
In the U.S, approximately 90% of all biopharmaceuticals approved by the FDA utilize a single source of agarose resins. This means products are sourced from one manufacturing site, presenting a high supply risk to long-term clinical trial material production.
In previous decades, only one vendor on the market had the capacity to supply agarose-based chromatography resins in the volumes required by the industry. Historically, this meant that an increased-risk, single source supply chain was the only available option.
Through our own customer-focused research, when we asked for your #1 concern in MAb production we heard a clear SOS - Secure our Supply.
So we have.
Purolite Life Sciences has built one of the world’s largest agarose resin manufacturing facilities, capable of supplying 30% of today’s global demand from a secure, UK-based location.
Now, for the first time, there is a viable alternative source of agarose chromatography resins for Downstream MAb purification.
The state-of-the-art facility is solely dedicated to the manufacture of Praesto® Protein A and Ion Exchange chromatography resins, and is purpose-built to secure global supply chains with the highest-quality, high-flow agarose-based chromatography resins.
With a 35-year heritage in global resin manufacture, Purolite takes a risk-based approach to supply management. All agarose-related activities occur at the centralised ISO 9001:2015 manufacturing facility in Wales, UK. This includes R&D, manufacturing, customer applications, quality and regulatory affairs together with commercial operations.
Supply risk is managed end-to-end, and alternate sources of key raw materials have been identified. Purolite uses a global network of qualified suppliers and has long-term supply agreements with periodic audits, to ensure consistency and ‘fit for purpose’ performance.
Praesto® resins utilize two distinct manufacturing technologies to suit your process needs.
Delivers resin performance equivalent to the market leading chromatography resins, enabling seamless dual sourcing.
A patented, continuous manufacturing method for uniform particle size agarose beads, delivering 'best-in-class', industry-leading performance.
Batch emulsified Praesto® products include:
Praesto® AP - a biosimilar to MabSelect SuRe LX*
Praesto® APc - a biosimilar to MabSelect SuRe*.
Both use the same ligand but vary in ligand density. Feedback from internal and customer evaluations by end-users suggests this holds true across multiple antibodies.
A comprehensive evaluation by Pabst et al of MedImmune published in the Journal of Chromatography A (1) provides similar conclusions.
As part of our commitment to ongoing manufacturing excellence, in November 2018 we commissioned an independent assessment from one of the thought leaders in the industry to accurately assess key business areas, such as:
Duncan Low, of Claymore Biopharm LLC, is an independent consultant based in Culpeper, Virginia. He formed Claymore Biopharm LLC after retiring from Amgen as a Scientific Executive Director in 2017. Prior to joining Amgen he held VP positions at Millipore and Pharmacia Biotech and was instrumental in developing their process chromatography capabilities.
For a full copy of his independent assessment report please click here