When Affinity Chromatography Limited received a Queen’s Award for Technology alongside the University of Cambridge, we were catapulted into a new era of plasma purification.

Welcome to Chapter 3.

By Steve Burton, President and Chief Scientific Officer, Astrea Bioseparations

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Stepping back to the past, Affinity Chromatography Limited and the University of Cambridge jointly won a Queen’s Award for Technology in 1996. This fantastic achievement really put us “on the map” as a company. The wider field started paying more attention to what we were doing, but a Canadian pharmaceuticals group developed a special interest.

To cut a long story short, discussions ensued, which ultimately resulted in the formation of a joint venture company called Prometic Biosciences. Over time, the three companies were merged into a single entity: Prometic Life Sciences.

These were exciting times. Suddenly, we’d shifted gears from serving pharmaceutical companies to being part of one, which opened up new programs of work. Two major projects stand out in my mind.

The first project, in collaboration with the American Red Cross, was in the plasma products field. Our role in the program was to develop purification technology for a new plasma protein production process (PPPS). Historically (and even today in many companies), plasma fractionation is performed using cold ethanol precipitation (a method originally developed by Edwin J. Cohn in the 1940s). Rather than relying on precipitation, we set out to develop a wholly chromatographic downstream process for sequential purification of plasma products using affinity adsorbents. In fact, we successfully developed 15 chromatography adsorbent products to achieve that goal. Clinical trials were completed for intravenous immunoglobulin (IVIG) and the world’s first intravenous plasminogen product – the latter of which gained regulatory (FDA) approval and is manufactured today using the chromatography products we developed, including a highly-specific affinity adsorbent for capture and purification of plasminogen.

The second major project (another collaboration with the American Red Cross as well as several academic institutions) resulted in the formation of another joint venture company called Pathogen Removal and Diagnostic Technologies (PRDT). The central aim of PRDT was to develop an approach to tackle the rather terrifying emergence of variant Creutzfeldt–Jakob disease (vCJD) – a new prion disease in humans with links to bovine spongiform encephalopathy (BSE or “mad cow’s disease”). There were concerns in the early 2000s that vCJD may be transmissible by blood, and we were tasked with developing an affinity adsorbent to capture the causative prion agent. We were successful in developing the world’s first filter that could specifically capture and remove vCJD prions from donated blood. Fortunately for the human population (arguably less so for the commercial consortium), the incidence of vCJD started to decrease and so our primary market vanished.

Interestingly, the hard work did ultimately pay off in the pharmaceutical industry, where related technology is used in the production of a human plasma product called OctaplasLG^® from Octapharma, which highlights “ligand affinity chromatography for prion reduction” as a manufacturing safety measure. I’m very proud of the lasting impacts of our collective endeavors.

Missed Chapter 2: Wallpaper plans and Manx manufacturing? Read it here. 

Read Chapter 4: A goddess emerges

First published for The Purification People newsletter, connecting downstream professionals.

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