Growth in 2019

Year on year, we continue to exceed both order intake and sales revenue. Orders are up 159% compared to the same period last year and in the coming weeks we will exceed the total sales revenues achieved for the whole of 2018.

This growth has been driven predominately by increased Protein A demand as processes scale up and advance through clinical trials, together with increases in the number of early phase clinical trials which utilise our resins. Europe and USA continue to be strong growth markets, but we observed higher than expected growth in Protein A demand in the Asia Pacific region.  Our advanced ion exchange platform has also grown exponentially based on the volume supplied in the same period of 2018.

Our indirect sales grew too - this is where Purolite Life Sciences acts as a CMO to couple ligands onto our agarose base beads.  We are pleased to announce that we have signed supply agreements with several of the top Life Science players, who have selected our Praesto® Pure base matrix for their ligand platform.

We are further encouraged by the continued advancement of Praesto® resins in clinical trials, and by the end of this year we expect our resins to be used in FDA-approved manufacturing processes in mature, regulated markets.  This is a major milestone for Purolite Life Sciences and we are truly proud that our resin technology continues to provide a strong impact and make real-world differences in the field of biopharmaceutical development. 

Today we are supplying two of the top ten global CMOs and eight of the world’s largest biopharmaceutical developers.

Product Performance

In mid 2018 we launched Praesto® Jetted A50, a new, ‘best in class’ next-generation Protein A agarose resin that uses our proprietary and innovative jetting technology to produce uniform-size agarose beads.  This novel process eliminates the need for costly and time-consuming sieving when compared to traditional batch emulsified manufacturing methods, which is surprisingly still used to produce almost all the agarose resins available on the market place today.  Our jetting technology is also environmentally friendly as we have removed solvents like toluene in the process.  This saves on processing time, reduces water usage and dramatically improves lead time. We combined this innovation with a new, high-performance Protein A ligand, NGL-Impact A™ from Repligen Corporation and, following extremely positive results from customers, we can confirm Praesto® Jetted A50 has now been chosen for a number of early phase clinical trials.

Research & Development

From an R&D perspective our teams have worked on the design of a new range of ion exchangers which will be known as Praesto® Jetted XS. This new chromatography platform is designed to be a novel, salt-tolerant strong cation exchange resin using our uniform agarose beads to provide very high capacities (>100 mg IgG/mL) - even under high salt concentrations.

Two bead sizes will be available - Praesto® Jetted XS 50, which provides excellent separation and, if needed, Praesto® Jetted XS 35, for powerful high resolution in more demanding separations. Our uniform agarose beads are unique and provide very fast mass transfer, more concentrated elution profiles and lower buffer consumption compared to other beads in this class. This improves productivity and facility throughput for our customers.

Unlike styrene-based resins, the innovation behind Praesto® Jetted XS agarose resins allow alternative storage solutions like 2% Benzyl Alcohol to be used.  This advancement addresses the trend to reduce the usage of flammable storage solutions in large-scale manufacturing.

Manufacturing

To ensure a secure supply of our resin, in September 2018 we opened our chromatography agarose manufacturing facility - one of the largest in the world. I am pleased to confirm that we have successfully completed commissioning, including the validation of several ion exchange and Protein A processes. This is an impressive transformation having only launched our first Protein A resin in 2016.  This provides us with a total of three manufacturing lines to produce agarose beads.

Summary

Today, Purolite is one of the largest resin providers globally and this success is as a result of our speed to market and our vision to develop and commercialise disruptive purification solutions.  We have followed the same strategy in the Life Sciences space and continue to do so by leading the direction of chromatography with our jetting technology.  These improvements in manufacturing have also allowed us to pass cost savings directly back to our customers.

 

How do we secure your Protein A resin supply chain? (360° Video)

 

Each day I am reminded that Purolite employees are the most talented and brightest minds in the industry. Our entrepreneurial approach to solving our customers’ problems and pain points in the fastest way possible truly underpins everything that we do.

Chris Major
Global Sales Director

Life Sciences, Agarose