Waters Corporation is a leading laboratory technology provider that offers innovative analytical instruments to assist scientists in reaching their scientific goals, increase productivity, and earn laboratory-based organisations a higher return on their investments in research, development, and quality control. In an interaction, KV Venugopalan, President, Waters talks about the company’s plans, projects in the pipeline, challenges and opportunities in the industry and more, with Usha Sharma
Waters provides researchers of complex diseases with unparalleled analytical tools to make breakthrough discoveries. Can you elaborate on this?
Waters’ portfolio of LC, MS, and informatics solutions supports discovery, research and development, and commercialisation in the life science and pharmaceutical industries for small and large molecule therapeutics. These include, but not limited to – proteomics, biomarkers studies, metabolomics, lipidomics, MALDI imaging, medicinal chemistry, regulated bio-analysis, drug metabolism and pharmacokinetics (DMPK), methods development, impurities analysis, natural products analysis, quality control (QC), process analysis, amino acid analysis, oligonucleotide, RNAi analysis, etc. As blockbuster drugs come off patent, the generics industry is poised to make a difference in people’s lives all over the world by providing access to medication that they previously couldn’t access or afford. With advances in analytical technology such as UPLC, and the USP’s initiative to likewise modernise compendial methods, generic pharma organisations are in a stronger position than ever to upgrade laboratories and improve productivity, efficiency, and be more confident in product quality using Waters platform solutions. Waters India plays a significant role in ANDA submissions, process and product development, quality control and assurance and regulatory compliance in all major companies in India.
The company offers its services to almost all sections of the pharma industry. Which are more complicated and why? How can the complications be overcome?
The challenge facing any laboratory technology provider is always to stay ahead of the industry by anticipating and preparing for every change in requirements — whether it is a scientific challenge, an engineering problem or regulatory challenges. Indian pharma industry has multiple opportunities and challenges. While India has the maximum number of US FDA approved plants outside the US and gets about 37 per cent of all the ANDA approved every year, we also get the maximum number of warning letters due to increased regulatory activities. Increasing price competition from other generic companies, high rate of attrition, lack of trained manpower, etc. are some of the major challenges facing the industry in India and therefore the suppliers like us.
Waters India has initiated many programmes to support the Indian industry and we are very unique in that sense. We conduct regular training and education programme to create awareness about quality systems and procedures, provide compliant ready products and help improve productivity to remain competitive. Our regular training programmes also assist them in managing high level of attrition without impacting quality and productivity.
How strong is the company’s research pipeline? Which are the new areas that the company plans to explore and how soon?
From introducing the first commercial HPLC system to the first UPLC system or the first computer based-data system to the ion mobility mass spectrometry system, Waters has always been the innovation leader in the industry. Our latest introductions include Ultra Performance Convergence Chromatography and QDa mass detector which is the smallest and easy to use MS detector designed for a chromatographer.
Let me also say a few words about another breakthrough technology from Waters, the iKnife. Generally when surgeons remove tumour tissue they try to leave a ‘margin’ of healthy tissue to ensure all the cancer is removed. Sometimes this means the patient has to remain under general anaesthetic for another 30 minutes or so while tissue samples are sent for analysis to check if the margin is clear. Even then, it is still possible that some cancerous tissue remains and the patient has to undergo further surgery to remove it. Now, a new technique based-on an ‘intelligent knife,’ called the ‘iKnife,’ promises to remove the need for lab analysis and the accompanying delay and it also helps avoid repeat surgeries. The iKnife is a combination of an established technology called electrosurgery that was invented in the 1920s and a new technology that is still emerging, called rapid evaporative ionization mass spectrometry (REIMS) introduced by Waters.
How many products have the company developed? Which of them is your blockbuster product and why?
Waters is the only company in the industry which designs, manufactures and supports all products that is sold, whether it is an LC system, MS systems, data and informatics solutions or columns and sample preparation products. Being the pioneer and innovation leader in the industry, majority of our products are trendsetters and have contributed significantly to our success. Waters Acquity UPLC systems, Alliance HPLC systems, Empower Chromatography Data Management systems, Nugenesis SDMS systems, Oasis sample preparation systems, Synapt HDMS Ion Mobility Mass Spectrometry systems, etc. are only few examples of our blockbuster products. They are blockbuster products not only because of their significant contribution towards our sales but also being disruptive technology that changes the way scientists and chemists perform analysis and achieve results.
What is the USP of your product?
Laboratories require performance, reliability, and workflow consistency. Whether a newly manufactured HPLC system, or one that is several years old, robustness, precision and reproducible results are essential to provide not only consistency, but also exceptional confidence in the analytical work flow, year after year. Waters strives to provide innovative technological solutions, products, and services to our customers by attaining a keen understanding of their needs and requirements. And our systems exceed the expectation of all our customers by helping them improve their performance, productivity and reliability of results.
Waters also offers services to the clinical research arena, however, growth in the Indian clinical research industry is not so alluring at present? What is your say on this?
The market has been challenging for the past couple of years. However, the situation is fast improving with clearly defined rules and regulations for obtaining permissions and conducting clinical trials in India. India continues to offer attractive destination for clinical studies for many reasons including large pool of patients, strong clinical infrastructure, etc. It is only a matter of time before we regain our dominant position in this sector.
Which new technologies will be launched at CPhI India 2014? Will they be cost effective?
Waters products are always cost effective as we focus our design on improving laboratory productivity, efficiency, throughput and overall performance. We will be showcasing a couple of our latest technologies during this exhibition.
IonKey – An ionKey/MS System adds the power to perform multiple analyses on limited sample volumes with increased sensitivity and ease of use.
QDa – ACQUITY QDa Detector is a mass detector built around the needs of analytical scientists for chromatographic analysis. Robust, reliable and requiring no sample adjustments, it integrates with your current LC, ACQUITY UPLC, UPC2 and purification systems. For the first time, any analytical scientist can consistently generate the highest quality mass spectral data, routinely without the need for any special training or expertise thus eliminating any need to contract out and wait for results from specialist analytical service laboratories.
UltraPerformance Convergence Chromatography (UPC2) is a broad-based, complementary analytical platform that is taking its place alongside LC and GC as one of the three essential separation technologies for modern laboratory analysis.
What is your road map for the next two years?
Better technology furthers better science. Waters continually pushes the limits of scientific possibility, helping our customers to reach their goals every day. Through constant collaboration with the scientific community, our customers benefit from innovation in our core technologies: separation and analytical sciences, mass spectrometry and laboratory informatics. Separately, or together, our solutions contribute to our customers’ enduring business and scientific success. We will continue to introduce innovative products to the market every year at the same time ensuring that our infrastructure is strengthened in India to provide superior support to all our users.