Then and Now: Ruta Waghmare

I started out in the industry right after my post doctorate almost 20-odd years ago in a bioprocess specialist role. Then, we were a team of scientists who worked side by side with our customers towards product adoption. What this meant was that we showcased how our products performed and made sure they delivered this performance in the process.

Over the years, new molecules have changed the therapeutic landscape but many of the manufacturing unit operations remain relatively unchanged, albeit with a few tweaks to suit some of the characteristics of these new molecules and new approaches to manufacture. Some of the biggest changes however come from the proliferation of the industry. When I joined, the majority of the drugs were developed and delivered by just a handful of global pharmaceutical powerhouses. Much of the R&D, process development and scale-up was performed under the umbrella of a parent company with a direct line of sight to full-scale manufacture coming from the parent. This has changed and the industry has seen many more players developing and commercializing drugs. Not all have any direct in-house experience of how to achieve it at the outset and we now provide as much consultancy relating to manufacturing in general as we do about product performance. With early biotech drugs coming off patent, the advent of biosimilars, an increasing number of contract research organizations (CRO) and contract development and manufacturing organizations (CDMO) players, and advances in science putting discovery, development, and manufacturing of novel therapies within the reach of a much larger group, it is a much more dynamic environment than it used to be.  There is not a one-size-fits all approach to development or to the support needed to achieve the process goals.

Today, we support a much wider range of molecules across a much more diverse range of companies and locations. We also have a much bigger toolkit of solutions to help.  These now support almost every aspect of manufacture, most notably with a multitude of single-use technologies that now permeated every aspect of a modern manufacturing process. My team has evolved beyond being testers of technology to consultants that can advise on technology choices, quantify performance and share best practice. Confidentiality is a prerequisite, but our cumulative experiences help us stay at the forefront of the industry and through continual innovation we help to drive the industry forward in every region. This requires communication, and increasingly global collaboration.

Covid-19 and the industry-changing drive to win the battle against the virus shows us just how much is possible when all parts of the industry pull together to protect global health.  We have been unprepared in so many ways but the trajectory of the industry during my time has always been closing the gap, albeit maybe out of good fortune rather than good consolidated global planning. During Covid, the industry truly came together for the greater good and the industry’s value is much more visible now than it was before.  There has never been a more challenging or rewarding time to be part of the industry.

Going forward, the industry has had a glimpse of what is possible, and it will never be the same.  In the immediate future we need to find a way to simultaneously produce both the vaccines and molecules for other therapeutics that may have taken a back seat.  But others, such as viral vectors and mRNA, have received an immense push forward as a direct result of COVID-19. We will continue to apply our knowledge and our portfolio to help maintain the momentum, to help deliver life changing drugs and to make them more accessible by simplifying development, by accelerating industrialization and helping to reduce costs. 

Coming full circle, we still work hand in hand with our customers and this will continue, but the depth of the collaboration has grown and will only continue to do so. We are driven by the knowledge that we make a difference, and this is powerful. Pall will continue to be an innovation enabler not just through innovation in our portfolio, but through the teamwork that develops the knowledge and ultimately makes it accessible to those that then do great things.

As the industry continually evolves and adapts to meet each new challenge, my team and I will be there to play our part.  We are motivated by knowing that when therapies are available to those that need them, we will collectively change lives for the better.

To find out more about Ruta Waghmare or any of our Biotech People please read our biographies page.