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Ashish Kulkarni Executive Vice President and Chief Technology Officer AvantorIt is common for CROs to specialize in specific areas like generating clones or monoclonal antibodies. For many CROs, this is a successful model which enables them to maximize the effectiveness of their research programs and resources.
"Finding ways to reduce the number of steps in the process, to work across multiple disciplines, to think entrepreneurially, and to respond with agility, those are the unique strengths that the CRO model of the future will possess"
However, there remain broader challenges in the biopharmaceutical industry. These include achieving the efficient production of therapeutic proteins and discovering new approaches for maximum protein expression; developing economical, flexible, and robust manufacturing processes; requirements of refolding proteins into their active state; and improving formulations for better dosage, stability, and injectability. Additionally, appropriately defined cell culture conditions are required to achieve maximum protein expression.
Often, biopharmaceutical companies may not have the time, resources, or process expertise to really “break the back” of these kinds of challenges. Typically, when a process is developed for drug development, whether making a new biologic or a protein target for screening of a company’s chemical library, the owner never really has the time to fully go through and develop “the optimal process.” They usually find something that approximately achieves a targeted goal, in order to meet deadlines and move the program forward as quickly as possible since time to approval and commercialization is critical for patients and also companies.
The Future CRO
Increasingly, customers are looking for CROs with a broader range of capabilities. The new CRO model will have the resources and world-class staff of scientists to investigate and solve both upstream and downstream challenges—from gene to protein to final formulation.
In fact, there are opportunities to make significant drug treatment and biopharmaceutical process breakthroughs by investigating materials-related life sciences challenges. Life sciences companies on the cutting edge are increasingly interested in partnering with research organizations that have in-depth experience with these types of issues.
What would such a partner be like? There are a few key principles the CRO of the future will need to embrace.
Multidisciplinary Teams Under One Roof
Problems don’t always come in one shape or form. A customer may present a challenge requiring several different specialties—a biology question, a chemistry-related issue, or an ingredient packaging problem. There may be challenges related to analytical, specification-driven issues. Or there may be underlying causes that are entirely different from what the customer thought—causes that require other disciplines, or even a cross-disciplinary approach.
When that diverse range of expertise is present in one location and dialogue, idea exchange happens much more rapidly, enabling a faster path to solutions. The end goal is to provide a full platform that parallels a customer’s own in-house R&D resources, working as a highly focused, rapid-response extension of the customer’s drug development efforts.
High Level of Customer Engagement
This kind of work requires a very high level of customer interaction. The CRO of the future will need to sustain a very high level of customer engagement and interaction to anticipate emerging requirements and offer timely solutions to customer challenges.
This includes engaging biopharmaceutical customers on areas that, in the past, they may not have had the resources to explore—areas such as optimizing drug formulation, protein expression process engineering, and scaling from pilot plants to full production.
Customization
Tomorrow’s CRO will need to provide an enhanced level of customization. It will need to provide the niche treatments that customers are looking for—very specific proteins, materials, or solutions. And develop all those things on-demand and with agility.
The new CRO model will have the raw material purification and formulation technologies and a scalable methodology so that tailored solutions to unique protein expression, purification, and yield challenges can be realized efficiently.
A Comprehensive Solutions Provider – One-Stop Shop
The CRO will need to be a comprehensive solution provider, a “one-stop shop” with all the materials, solutions and expertise needed from the start of a customer’s development process up to full scale production.
It will need to go from a concept all the way to developing manufacturing capabilities for customers, giving them all the material solutions needed. If a CRO has insight into materials-related issues such as trace metals characterization, and how those issues impact the scalability of biopharmaceutical processes to targeted yields, it will be better equipped to provide complete solutions.
Staffed with Entrepreneurial Scientists
Scientists who have a broader, more diverse view of their role in their customers’ success are also an important, competitive advantage for the new generation of CROs. These cross-disciplinary research staffs will attack projects in a highly disciplined, interactive way, combined with an “entrepreneurial” energy that always seeks to shorten the interval from initial understanding of a customer’s challenge to reaching the end solution. The atmosphere will need to encourage risk-taking, customer interaction, and leveraging knowledge from colleagues.
Those entrepreneurial scientists will quickly get to the heart of the matter—determining where the potential is to add value in any particular situation. And see how they can work together to achieve a breakthrough result.
Why the CRO of the Future Matters
Today, the potential for groundbreaking new innovations in life sciences has never been greater. At the same time, the complexities of engineering genes and proteins to create targeted, breakthrough therapies—and doing so in ways that scale to productive yields—can lead to obstacles that can slow the development of vital new therapies.
Finding ways to reduce the number of steps in the process, to work across multiple disciplines, to think entrepreneurially, and to respond with agility, those are the unique strengths that the CRO model of the future will possess.
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