Waters, as a strategic partner to the pharma industry, can help India become a world leader in biosimilars

How is the industry’s approach to drug development transforming? What are the imperatives that led to this change? How is Waters aiding advancements in drug development?

A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. While there are significant obstacles to marketing new drugs, the past 15 years have shown an increase in the number of drug approvals. The Food and Drug Administration (FDA) approved an average of 43 drugs in 2014-18, compared to an average of 23 in the first decade of the century. 

There is no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. The medical field is evolving fast and toward the direction of treating diseases previously incurable using genetic manipulations and genome editing. Super expensive solutions (up to $3 million per patient), albeit truly innovative in nature, make these treatments unavailable to most of the world’s population. 

Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. These novel drugs are impossible to develop, manufacture, and bring to market successfully without the use of analytical technologies, such as liquid chromatography (LC) and mass spectrometry (MS) instruments, chromatography columns and data capture, and analysis software offered by innovative companies, like Waters Corporation. For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. 

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. When we pair Wyatt’s multi-angle and dynamic light scattering technologies with Waters’ LC instruments, size-exclusion chromatography columns, and data capture software, we can deliver to our customers a richer set of data for large molecule drug development and QA/QC. 

How is technology ushering in new paradigms in pharma R&D? How is Waters utilising technology to accelerate and enhance processes in the life sciences industry?

Drug company R&D is constantly pressured to improve productivity, provide support across geographies, and navigate complex regulatory environments. To manage these challenges, it becomes imperative for the pharmaceutical industry to keep pace with emerging technologies, and adopt efficient and agile operating models. Looming patent cliffs on blockbuster drugs, a constrained pricing environment, plus the prospect of pricing reform (especially in, but not limited to, the US) means many companies are prioritising R&D productivity improvement and pushing to get more out of every dollar invested in R&D. 

Waters, a global leader in analytical instruments and software for over 60 years, is focused on helping to solve problems that matter for customers in the life, materials, and food sciences. Leading pharma companies are already experiencing the benefits of our support in the reduction in errors, faster cycle times, enhanced innovation, higher productivity, and better compliance.

In October of 2021, Waters and Sartorius began a collaboration to help bioprocess scientists accelerate clone selection and process development with new tools for testing and measuring the product quality of recombinant drug products produced in a multi-parallel bioreactor.

This collaborative work facilitated the transfer of bioreactor sample data and analytical results between Sartorius Ambr multi-parallel bioreactor platforms and the Waters BioAccord LC-MS system. By co-locating these instruments in upstream bioprocessing labs, analytical turnaround times were significantly reduced as compared to the more traditional process of sending out samples to core analytical labs for the data needed for point-of-need decision-making. By empowering process development scientists to generate process quality attribute (PQA) data themselves, we enable them to make decisions about which molecules to advance into pre-clinical development more rapidly.

 With our joint announcement on June 4, 2023, Waters and Sartorius entered a new phase of our collaboration, this time to support downstream bioprocessing as well. By combining the Waters PATROL UPLC Process Analysis System as an at-line process analytical technology (PAT) tool with the intensified bioprocessing operations of the Sartorius Resolute BioSMB multi-column chromatography platform, we can help optimise continuous downstream operations to reduce production costs (e.g., resin consumption), and effectively monitor and manage product quality.

Waters and Sartorius are committed to supporting biologics manufacturers with the best upstream and downstream process development and drug product quality analytical tools to ensure the efficient manufacturing of safe and effective drug products. Our collaboration will continue with those objectives in mind.

Waters recently acquired Wyatt, a provider of light scattering and field-flow fractionation technologies. How will it enhance Waters’ capabilities to serve the life sciences market in India? 

By expanding our analytical capabilities beyond what LC-MS can provide alone, Wyatt brings new expertise and stronger data to novel modality applications which will improve our ability to help our customers solve some of the technical challenges in the development of biotherapies.

We know leading Indian companies are already using Wyatt light scattering technology, and the Waters-Wyatt portfolio will bring strong opportunities and leverage the existing direct and distributor presence. 

The biotechnology market in India has grown 14 per cent in the last year to more than $80 billion along with the offering of a strong CDMO presence. This aligns well with Waters and the expansion to customers with Wyatt’s light-scattering technologies. 

Any more interesting M&A in the offing? 

Waters is always looking at both organic and inorganic growth opportunities that can help us better serve our customers. We are excited by the recent acquisition of Wyatt Technology and the opportunities it can add to our portfolio. 

That said, Waters is investing to increase its technical expertise, capabilities, and reach into high-growth adjacent markets in areas that include bioprocessing, clinical diagnostics and early disease screening, sustainable polymers, and batteries.

What are the growth opportunities opening up in the pharma sector, globally and in India? How poised are you to leverage them?

India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. A large presence of local players producing branded generics, along with lower price levels, has provided India with a unique opportunity. Almost 50 per cent of drugs produced are exported and the remaining 50 per cent is consumed domestically. Pharma has learned to respond by producing large-scale drugs quickly compared to other countries. By the end of 2022, Indian pharma turned from volume to value creator. 

Waters has been a trusted partner to the Indian pharma industry during this time, providing liquid chromatography and mass spectrometry (LC-MS) technologies, and expertise that is vital to ensure quality and pre-release drug safety. Our instruments are widely deployed in pharma laboratories and contract manufacturers for QA/QC of small-molecule generic and large-molecule drugs. 

The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025. The industry is looking for the identification of the right biologics or biosimilars to treat the next generation of auto-immune disorders, cancer, diabetes, rheumatoid arthritis, etc. In the coming years, approximately 10 biologic blockbusters will be released from the patent, creating enormous opportunities for Indian manufacturers of biosimilars to make the product most cost-effective.

With our acquisition of Wyatt Technologies, Waters India is well-aligned to support the industry as newer drugs and biosimilars are brought to market. When we combine Waters’ world-class LC instruments with Wyatt’s innovative light scattering technologies, we are positioned with vital products that biopharma companies use for discovery, product development, manufacturing, and QA/QC. Waters has an incredible opportunity as a strategic partner to the pharma industry to help India become a world leader in biosimilars.