Ahead of CPHI Milan, EPM spoke to Hayley Crowe, executive vice president and general manager of Ecolab's Global Life Sciences sector, to discuss the company's approach to addressing the growing demand of cell and gene therapies (C>s) and supply chain challenges, while maintaining its sustainability goals.
Q. How are you innovating to meet the growing demand for personalised medicine and cell and gene therapies?
New modalities, like cell and gene therapies (C>s) currently focus predominantly on targeting rare diseases, which typically have small patient populations. For many of these patients, there are no other effective treatment options, and the success or failure of a C> can be life-altering. Inconsistent product quality could lead to treatment failure or lead to adverse effects on patient health. As a result, ensuring process and scale-up consistency has become increasingly critical for these new complex therapies.
Ecolab’s cleaning and disinfectant products are specifically designed to help maintain the sterile environments required for biologics production, minimising contamination risks and helping to ensure the highest standards of quality, and safety. These products are optimised to reduce waste, lower costs, adhere to regulatory requirements and enhance efficiency, leading to streamlined production processes.
To further support C> manufacturers, Ecolab provides comprehensive virucidal efficacy data, helping to confirm the effectiveness of our cleaning and disinfection solutions under highly sensitive and controlled environments. Leveraging a deep understanding of regulatory compliance, we guide customers through complex agency requirements, ultimately helping to minimise costly downtime and streamline the path to the clinic.
Additionally, our portfolio of ion exchange resins offers manufacturers a cost-effective solution for gene therapy purification and polishing.
Q. What strategies are you implementing to address supply chain challenges in a post-pandemic world?
Post-pandemic analyses have led developers and manufacturers to seek risk mitigation in their supply chains. Consequently, these companies are increasingly relying on partners that leverage asset distribution, multiple source supply, and clear business continuity plans.
Ecolab has a dedicated supply chain team with ongoing business continuity plans to help ensure delivery and multi-location supply. Our new state of the art facility in King of Prussia, Pennsylvania, USA, is our latest expansion to support our customers’ supply chain continuity plans and is on the forefront of optimising plant operations. With business continuity and a resilient supply chain at the top of mind for our customers, ensuring a robust, redundant supply of active pharmaceutical ingredients (APIs), excipients, and raw materials, especially within specific regions, is a top priority for Ecolab.
The new King of Prussia site complements our existing manufacturing facility in Romania, allowing us to offer our customers more flexible and secure supply options. By establishing facilities in these key regions, we can help mitigate supply chain risks and create consistent, reliable access to the materials our customers need. This approach not only improves business continuity, but also supports the potential need for local sourcing, providing peace of mind in an increasingly complex and globalised market.
Our continued investments in expanding our manufacturing footprint underline our commitment to supply chain resilience and growing with our customers, helping us to better serve our clients across the pharma and biotech sectors.
Q. How are you adapting your sustainability goals to meet new regulatory pressures and environmental expectations?
Ecolab demonstrates its sustainability commitment through a strategy focused on compliance, innovation, and partnerships. The company continuously aligns its solutions with evolving environmental regulations, such as the EU Green Deal, helping customers meet increasingly stringent standards. As part of its global efforts, Ecolab is committed to the Science Based Targets initiative (SBTi), working to reduce greenhouse gas emissions in accordance with the Paris Agreement.
Water conservation is a key pillar of Ecolab’s sustainability approach, with a particular focus on its Water for Climate program. This initiative supports businesses in optimising water use to meet both regulatory and environmental objectives. Ecolab also invests in cutting-edge technologies like Ecolab 3D and CLEEN by Ecolab, which improve resource management through enhanced data integrity and process knowledge.
In addition to operational efficiencies, Ecolab prioritises sustainability across its supply chain. The company is actively working to reduce waste, source renewable energy, implement an electric vehicle fleet and adopt recyclable packaging solutions. These proactive measures ensure Ecolab not only works to stay ahead of regulatory requirements, but also positions itself as a leader in sustainability within the industry. Through these ongoing initiatives, Ecolab is making excellent progress toward achieving its sustainability goals while delivering solutions for clients.
Q. What roles do digital transformation and AI play in improving efficiency in your manufacturing processes?
Digital transformation and artificial intelligence (AI) are revolutionising pharma manufacturing in critical ways, from enhancing efficiency to reducing costs and improving operational reliability. Two key areas are automation/digitisation and data integration.
Automation, particularly in manufacturing processes, can significantly reduce human error while increasing throughput. For example, robotic technology is increasingly used in aseptic fill/finish processes to streamline production.
Data integration, together with AI and machine learning plays a critical role in optimising operations. By enabling systems to gather and analyse data across different platforms, Ecolab can identify inefficiencies, predict maintenance needs and optimise production schedules. AI-driven systems are transforming environmental monitoring that directly affect quality control and regulatory compliance. These systems monitor production in real time, identifying potential issues before they escalate. As a result, we can quickly apply the appropriate solution, helping to ensure consistent product quality and minimizing waste.
In highly regulated environments demanding stringent record-keeping, including the pharma and biopharma industries, AI can simplify compliance, particularly when relying on automated documentation and ensuring traceability. Digital logbooks, cleaning validation, and batch execution modules address these needs, providing pharma manufacturers with the tools they need to stay compliant while improving overall operational efficiency.
Q. How are collaborations and partnerships influencing your approach to drug development and manufacturing?
At Ecolab, maintaining close collaboration with our customers is our top priority, as we believe it’s the most effective way to help them achieve their goals. We’ve made significant investments to enhance our global technical support infrastructure, including the strategic placement of Field Applications Scientists worldwide to ensure we can provide expert support, no matter where our customers are based.
In addition, we’ve established a state-of-the-art Bioprocessing Applications Lab, which houses staff and equipment ready to be an extension of our clients’ development teams. These technical experts work directly with our customers and their products to design tailored study plans to help overcome specific purification challenges. Through this hands-on approach, we support our customers to optimise their processes, evaluate resin lifecycles, and perform cost modelling analyses, all while addressing resource constraints.
Across biologics, our relationship with Repligen has also strengthened our ability to offer a comprehensive suite of solutions. By combining Ecolab’s expertise in resin technology with Repligen’s bioprocessing innovation, we can offer an unmatched portfolio for purification challenges, to support our customers in optimising their workflows and improve efficiency. This collaboration reflects our commitment to providing customers with best-in-class tools and services to drive innovation and efficiency in biomanufacturing.
We collaborate closely with our resin-based API and excipient customers with proactive lifecycle support. Working together with our customers’ teams in new formulation development is a critical focus area. Our team of experts specialising in Pharmaceutical and Nutraceutical applications for ion exchange resins can provide critical support to many existing drug products as well as new development projects. Additionally, our agile quality and regulatory teams proactively work with customers and regulators, bridging challenging new regulations with our customers’ best interests.