Accelerate your biologic drug development with Praesto®
Chris Major reflects on the performance of the Agarose business of Purolite in 2020 so far, what the future holds for the Praesto® line of agarose bioprocessing resins.
Chris Major, Global Sales and Marketing Director
As a privately-owned family business, we do not report financials to the market, but we do feel it’s important to provide regular business updates to our customers and business partners. As such, we have done this at regular 6-month intervals since 2017.
As the first half of 2020 draws to a close, I wanted to provide you with the latest business update for the Agarose Chromatography business of Purolite.
INNOVATION COMMITMENT AND GROWTH PLAN
We first started our Praesto® bioprocessing resin journey back in 2014, and commercialized our first ion exchange chromatography resin shortly after, in 2015. By 2016, Praesto® was successfully implemented into human clinical trials, and our first alkaline-tolerant protein A resin was launched. Response from the market was overwhelmingly positive, allowing us to continue to invest heavily into protein A resin improvements and innovation.
To set the scene for the market conditions during that time, the vast majority of the biopharmaceutical developers were using a well-established but dated resin technology for their mAb processes. This traditional ‘batch emulsified’ resin technology was first developed in the 1950s as a method of producing agarose base beads. With only minor modifications being implemented over the ensuing 60 years, fundamentally, the technology provided the same limitations in 2015 as it did when it was first developed. It’s interesting to compare this scenario to the automotive industry, wherein that same time period we have continually seen major advancements to improve safety, reliability and environmental impact through electric vehicles, as market attitudes have shifted over time. Whilst significant advancements have been made in the biopharmaceutical industry in that timeframe - where there is a strong focus on improved productivity and cost of goods to promote better access to affordable therapeutics – it was interesting to note that in 2015 production of these novel, vital treatments were still relying on a 60-year-old technology. Jumping forward to 2020, it’s a fair and unfortunately sobering statement that the current Covid-19 pandemic that we continue to face together has only heightened the need for rapid, cost-effective and reliable production of biopharmaceuticals.
OUR VISION - BRILLIANCE IN BASE BEADS
As a global leader in resin bead production since 1981, and the only global company to focus solely on resin technology, Purolite® knew that only we could break the status quo, re-write the rule book, and truly re-invent the agarose base bead to be suitable for modern and future processing demands. We knew that Praesto® products would have to perform better, our lead times would have to be shorter, and our technical staff would have to be the best in their fields to truly make an impact. With that ethos, our vision became clear and we developed the patented, and now industry-standard technology, referred to as Jetting.
BEST-IN-CLASS MANUFACTURING - JETTING TECHNOLOGY
Jetting truly innovated agarose base bead production, allowing us to precisely control bead size and distribution to deliver higher consistency, enhanced performance, shorter lead times, and significantly reduced environmental footprint. The process uses no solvents, and provides 100% yield (this can be as low as 60% in batch emulsification production) and produces uniform beads of a target size, with no fine particles. This eliminates the need for a time-consuming and costly sieving step during manufacture. The lack of fine particles in Praesto® Jetted resins offers several benefits, such as:
We started 2020 with high expectations for revenue, building upon 5 years of continued success and increasing adoption of our Jetting technology.
In March 2020, we were delighted to announce that our next-generation Jetted protein A resin - Praesto® Jetted A50- reached FDA-approved commercial manufacturing for a mAb process. To reach commercial manufacturing within 2 years of launching the product is testament to our resin technology leadership.
Despite the global Covid-19 pandemic that followed shortly after, our successes year to date continued. From a personal perspective, I was proud to see Purolite supporting global initiatives to support the fight against Covid-19, by donating large volumes of high-quality PPE to medical facilities in both the UK and Romania.
Despite the unprecedented global conditions during this time, Purolite® continued operations in order to maintain supply to our customers, subject to compliance with the latest measures to ensure the safety of our staff. The response from Purolite® employees around the world was truly inspiring, and the effort to continue to meet customer needs during what was a difficult time for us all, was humbling.
As a result of this exceptional effort, by May, our order intake had already surpassed our revenue target for the full year. We predict similar success for the remainder of 2020 and, interestingly, we expect 80% of our future protein A resin revenue to come from our Jetting technology. Today, we have around 250 ongoing pre-clinical trials around the world and we are proud that Praesto® resins are being used for diagnostics and research into potential treatments for Covid-19. Our customer list continues to grow, with more of the world’s largest biopharmaceutical developers choosing to adopt Jetting technology for their process.
A LOOK TO THE FUTURE
Purolite® has invested over $150 million into a global expansion program in recent years, and work is ongoing to increase the production capacity of our Jetted resins to meet increasing demand. This additional investment comes shortly after opening one of the largest agarose-based resin manufacturing facilities in the world. Based in the UK, the facility is capable of supplying 30% of the current annual demand for agarose-based bioprocessing resins, globally.
Research and Development
Alongside expanding our facilities, we continue to invest into long-term growth through leadership in resin innovation. Later this year we will expand our protein A platform further achieving new levels of purification performance, specifically with an alkaline tolerant protein-A affinity resin that will elute FC binding mAb’s at milder conditions in the range of pH ~4.5 to enable high yields for pH-sensitive mAb’s preventing aggregation.
I hope this update has proven insightful and I look forward to detailing our future successes in my end of year communication. I’d like to thank all of our customers who have partnered with us throughout our journey, and we look forward to continuing to support you with the very latest in resin technology.