An Insider’s View on CDMO Services for Biologics

Q: What are the primary challenges biopharma customers are currently facing?

A: During conversations with customers this week, several recurring challenges were highlighted. The most pressing issue is meeting timelines, especially given the industry's rapid changes. Customers are deeply concerned about staying on track with their project schedules. Another significant challenge is navigating regulatory requirements. Customers rely heavily on our expertise to navigate this nuanced environment and ensure compliance. Supply chain reliability is also critical. Having the necessary supplies available at the right time is essential for maintaining project momentum. Finally, addressing technical challenges with molecules often requires specialized knowledge.

Q: How does Thermo Fisher’s biologic services address these challenges?

A: Our biologics group is well-equipped to tackle these issues. We have substantial capacity across multiple sites globally, allowing us to meet customer demands promptly. Our integrated solutions encompass drug substance and drug product divisions, as well as clinical packaging, labeling, and shipping services, providing comprehensive support. We also leverage advanced technologies, including single-use bioreactors, high-throughput screening methods, and automated fill-finish systems, to deliver solutions that are tailored to our customers' needs and can easily scale as demand shifts throughout commercialization.

Q: There have been many conversations around the strategic importance of being able to quickly ramp up production capacity in biologics development. Why is that so important today, and how is Thermo Fisher meeting that need?

A: The ability to quickly ramp up production capacity is crucial in today’s biopharma landscape for several reasons. The demand for biologics is growing rapidly, driven by advancements in personalized medicine and targeted therapies. The competitive nature of the industry means that speed to market can significantly impact a product’s success. Delays can lead to missed opportunities and lost market share.

At Thermo Fisher, we address this need through scalable solutions and strategic investments. We have a global network of facilities equipped with advanced technologies that allow us to increase production capacity swiftly. Our single-use bioreactors and automated fill-finish systems are designed for rapid scale-up. Our experienced team of subject matter experts can quickly adapt processes to meet increasing demands. This combination of technology, expertise, and network access ensures that we can support our customers in bringing their biologics to market faster, without compromising on quality or compliance.

Q: The combination of market dynamics and the intricate nature of biologics development has biologics companies focusing closely on reducing lead times to remain competitive and meet patient needs. What strategies does Thermo Fisher employ to reduce lead times in biologics development?

A: In biologics development, reducing lead times is critical. It accelerates the time-to-market for new therapies, which can be lifesaving for patients and financially beneficial for companies. At Thermo Fisher, we employ several strategies to ensure reliable logistics and supply chain resilience, both of which are key enablers for minimizing lead times. Advance planning and proactive program management help us anticipate critical activities and stay on schedule, and our integrated systems support real-time data flow and decision-making to streamline drug substance and drug product development, demand planning, and clinical trial supply execution into a single customized solution. Finally, our continuous improvement initiatives fine-tune our workflows and processes, enhancing efficiency and reducing development timelines for our customers.

Q: Technology transfer is critically important in today's biologics landscape as it enables companies to rapidly scale up and globally distribute complex biologic products, maintaining high-quality standards in a tightly regulated environment. How does Thermo Fisher streamline tech transfer to accelerate time to market while maintaining quality?

A: We significantly streamline technology transfers in biologics development by offering a single point of contact throughout the process. This centralized approach ensures consistency in quality and processes, simplifying communication and project management across various phases and sites within Thermo Fisher. We prioritize standardizing methods and protocols to ensure smooth transitions, whether transferring technologies from customers to our facilities or between development stages.

Our experienced team leverages extensive expertise to anticipate and efficiently address potential issues, ensuring compliance and reducing delays by adeptly navigating the complex regulatory landscape. A collaborative approach with our customers, characterized by constant communication and transparency, allows us to meet development milestones and customer expectations effectively, advancing their programs and addressing patient needs.

Our ability to adjust production volumes effectively is essential during scale-up phases. By managing the entire development and manufacturing process under one roof, we enhance risk monitoring and mitigation. This comprehensive oversight not only reduces downtime but also streamlines project timelines, accelerating the time to market. Overall, our approach boosts efficiency and ensures faster and more reliable delivery of biologic therapeutics to the market.

To learn how leveraging an integrated approach can help expedite the early-phase development of small molecules, read our recent whitepaper.