Expanding into biotherapeutics

Biotherapeutics, believes Dr. Tim Riley, Vice President and Managing Director of the Pharmaceutical Business Operations at Waters Corporation, is rapidly growing. NGP asked him how Water’s mass spectrometry systems help to characterise these therapeutics in order to control their quality and efficacy.

NGP. What do you see happening within the pharmaceutical market?

TR. Many of the large pharmaceutical companies that we’ve talked to are diversifying their product position by expanding into biotherapeutics. This is certainly reflected in recent announcements and acquisitions, as they pull in increasing amounts of protein and vaccine products to strengthen their portfolios.

With this, the demand for generics and biogenerics continues to grow quite rapidly, which is affecting the overall landscape of the industry. Additionally, the increased outsourcing to contract research organisations (CROs) for more than just clinical trial support is an activity that Waters has recognised and has responded to.

NGP. In light of the trends that you have highlighted, what have you done to address the changing pharmaceutical market?

TR. Waters continues to work with the pharmaceutical industry to understand their business drivers and goals. If we take our ACQUITY UltraPerformance LC System, its development was exclusively in response to pharmaceutical executives stating that the efficiency of laboratories had to increase. This was not just in discovery, but also in development and manufacturing. The efficiency discussion revolved around throughput, and extended to the utilisation of investment capital, human resource and laboratory space. With this input, in 2004 Waters developed the ACQUITY UPLC system, along with complementary single quadrupole and tandem quadrupole mass detectors, as a tool to address those three areas. In response to market demand, shortly after, we opened up the ACQUITY UPLC system to mass spectrometers made by ThermoFisher Scientific, Bruker Daltonics, and ABI/MDS Sciex.

We’ve taken that same blueprint and developed information management tools that allow companies to capture, store and repurpose scientific data. Our approach was again dictated by the pharmaceutical industry as they tried to streamline the process of filing with government agencies. To address the increased demands in data throughput and subsequent interpretation, our computer software and data analysis packages were designed not only to handle the data load, but also to make the task of assessing this data more intuitive. And to address the regulatory aspects, this enhanced level of automatic data processing required a degree of transparent validation to ensure the results’ integrity. And finally, we developed products to solve the problem of harvesting, preserving and presenting the knowledge garnered.

NGP. What are the technology trends that you see within the pharmaceutical market?

TR. The adoption of mass spectrometry is rapidly growing in areas outside the traditional R&D environment. Laboratories further down the development timeline are looking for the added specificity and information that a mass spectrometry system can provide. We are also seeing this technology move into geographical areas that have traditionally lagged in adoption. As technical expertise and practical needs grow in these areas, the demand for mass spectrometry increases.

Since we’ve seen this expansion in the use of LC/MS across a wide array of new application areas, we developed an MS portfolio to address the entire spectrum of user abilities. For novice users that may be more chromatography focused, we worked in collaboration with pharmaceutical companies to provide walk-up, or open access capability.

With new single and tandem quadrupole mass detectors for our UPLC platform, our development efforts have stressed easy-to-use, comprehensive solutions – all on the Empower Software platform that chromatographers rely on. These extended innovations for the routine use of LC/MS really made an impact in solving mission-critical bottlenecks while delivering exceptional return on investment.

NGP. In your view, what is the most exciting recent development to come out of Waters?

TR. Since the emphasis on biotherapeutics is rapidly growing, companies need to be able to characterise these therapeutics in order to control their quality and efficacy. To that end, Waters developed a mass spectrometry system that allows these laboratories to acquire information that was not available to them with conventional MS. By separating constituents by not only size and charge but also by shape, this Synapt High Definition Mass Spectrometry System, or HDMS technology, allows laboratories to understand their therapeutics better. This additional dimension of sample separation, known as ion mobility, provides increased specificity and sample definition previously unattainable. This knowledge is not only useful at the drug development stage, but also in the research stage where scientists can study changes within molecules under certain conditions.

Just as UPLC technology changed the nature of liquid chromatography in 2004, we’re already seeing HDMS technology have a significant impact on small and large molecule research in the areas of protein characterization, metabolite identification and, of course, biopharmaceutical applications.

NGP. As you look at the solutions that Waters has developed, can you articulate the impact within the market place?

TR. Solutions lie in increasing the efficiency and quality of the analytical data through improved separation power in the form of UPLC and HDMS, improved MS performance and ease of use, improved informatics, and high quality customer support and service. As mentioned previously, our emphasis is on improving analytical productivity. The ACQUITY UPLC system is an excellent example of what I am talking about. It provides order-of-magnitude increases in resolution, sensitivity, and speed of analysis. As news of this technology spread and interest quickly caught on, scientists began to embrace its potential and began to drive new products through the development process faster, push MS performance to the next level, and open new doors to scientific discovery.

We can expect UPLC to supplant traditional HPLC for many more analyses. The advantages are too compelling to ignore. This is an exciting time for our industry. The everyday tools that are used by scientists have seen a tremendous amount of recent innovation from the analytical instrument vendors. Since we released ACQUITY UPLC onto the market three years ago, there is a lot of activity, and scientists and business managers are carefully re-examining long-held assumptions about generating analytical information, managing laboratory workflows, and taking full advantage of these innovations in the industry.

NGP. What do you see as the next hot topic within the industry?

TR. Biotherapeutics is the most important area now and into the foreseeable future. As the industry looks to balance out where they spend their R&D dollars, solutions unique to the challenges they face will be required. This focus will continue to drive the analytical instruments industry to develop solutions that are not just adaptations to existing technologies rather solutions, like the Synapt HDMS, that provide these scientists with new ways to solve their challenges.

Genotoxins are also of acute concern within the industry. To that end, the ability to analyse for these compounds is of utmost importance. The requirement for robust and highly sensitive solutions for this is continually highlighted in our interactions in the industry.

We’re always keeping our finger on the pulse and developing important strategies and collaborations to address these and other up-and-coming areas. We’re fortunate to have a very talented group of scientific and business development experts in cutting-edge applications so that we may better understand both the analytical and operational drivers behind the latest pharmaceutical trends.

NGP. Can you comment on Waters’ recent re-branding and ‘The Science of What’s Possible’?

TR. Our focus has always been on meeting the changing needs of our scientists and organisations that rely on laboratories to meet regulatory requirements and create new products. Over the last decade or so, we’ve become more than just a provider of laboratory products and services; we’ve become an essential business partner with a keen understanding of the how the lab and our innovative solutions affect business results. As we deliver a connected set of technologies designed to work together as a total system, we provide scientific organisations with quality information faster, and make a meaningful impact on their business and scientific bottom line.

We’ll continue to drive this product strategy to reflect customers’ needs, and with our ‘The Science of What’s Possible’ positioning, we’re simply making a promise to our current and potential customers. We’re committed to changing the way pharmaceutical companies do business – as a partner in pursuing critical objectives by helping them find solutions to their most difficult problems.

BIO

Dr. Tim Riley, Vice President and Managing Director of the Pharmaceutical Business Operations at Waters Corporation, began his hands-on experience with mass spectrometry in 1974. In 1984, he joined VG Instruments and continued his involvement in mass spectrometry when VG was acquired by Fisons Instruments in 1990 and participated as part of the team that split from Fisons Instruments to form the Micromass organization in 1996. One year later, the Micromass organisation was purchased by the Waters Corporation.