Roundtable Part 4: Stakeholders' Roles in Promoting Continuous Processing Technologies

Our efforts to implement continuous manufacturing required significant internal efforts to develop, optimize and implement the technology in Lilly’s Development and Manufacturing organizations. During that time, our internal efforts were augmented with shared learning with other companies and vendors, especially with companies that had made significant progress or already had approved products using the technology. This occurred through participation in various technical conferences and events, collaboration on published scientific literature, and one-on-one benchmarking. We also have been part of Industry consortia to develop positions that can inform regulatory guidance or positions on specific topics related to continuous manufacturing. Lilly maintains an active agenda across these areas, and we plan to continue to encourage and support further advancement and adoption of this technology, while shaping the environment.

Equipment and methods for continuous manufacturing have existed for the more than 60+ years. However, with the product being under limited patent life and due to marketing pressures to get the product to the market no significant effort is made to commercialize the most optimum and economic process. Companies know that the patient will pay the price to get well and extend their life. When the product goes generic, many file for ANDAs and economies of scale are lost and commercialized processes are generally batch processes.

FDA created the Emerging Technology Team (ETT) to help facilitate implementation of novel pharmaceutical technologies, including continuous manufacturing. The ETT responds to pre-submission questions and proposals about advanced pharmaceutical manufacturing technologies. The ETT also identifies potential gaps and policy issues and facilitates their resolution. More details on the ETT are given in the Guidance for Industry “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.”

The ETT helped support FDA's approval of four continuous manufacturing products so far, including the first new drug product made using continuous manufacturing and the first switch from a batch process to a continuous process for a previously approved product.

The FDA has also used external grants, internal research activities and process modeling to better understand continuous manufacturing processes. Process modeling can help scientists determine how changes in process parameters affect drug quality.

Next Generation Processing is innovation through collaboration. It is a powerful triangle encompassing customers, suppliers, regulators, academics, government agencies and industry associations working collaboratively. The approach must be holistic from upstream down to final fill in order to be successful. Suppliers also need to develop truly integrated and automated solutions for our customers, enabling them to achieve their targeted goals for speed to market, cost savings, and quality improvement. Awareness and education through real case studies and practical hands-on training courses can demonstrate the value and promote Next Generation Processing technologies, while installing confidence that this is the right path forward.

It sounds cliché, but Pall Corporation was built on innovation. Our team takes pride in advancing the markets in which we serve with mission-critical equipment, systems and consumables, complemented by exceptional customer service and support.

From the beginning, Pall Biotech was a leader in stainless steel equipment. As the industry evolved, we became an early pioneer in the development of integrated single-use technologies. Now, our team is focused on leading the industry in bringing full-cycle, scalable continuous bioprocessing solutions to fruition. We are also fully committed to working with industry associations, educators, partners and clients to get there.

As a leader in Single Use Technologies, Thermo Fisher Scientific has been investing in developing single use platform technologies in both upstream and downstream continuous processing. Biological manufacturers have embraced our open architecture approach and we will continue to collaborate with customers to provide flexible and economical solutions that meet or exceed industry requirements. Making sure our technologies comply with guidelines such as BPOG, BPSA, USP remain part of our primary focus. We will continue to develop and promote automation solutions in continuous processing across all layers like our SmartParts (sensors and devices), SmartSystems (integrated SmartParts, universal hardware, distributed control and flexible software enabling all scales of upstream and downstream processes) and SmartFactory (integrating unit operations into a seamless network).