By Gabriella Dahlgren, PhD Mr. Michael O’Brien
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The topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have obtained global marketing approval for continuous manufacturing platforms. To accelerate the adoption and implementation of continuous manufacturing, it is of paramount importance that we leverage the learnings from all sectors of the industry through respectful collaboration while encouraging discussion of differing points of view.
There are considerable opportunities for biologics and API manufacturing to utilize the expertise gained by small molecule drug product manufacturing successes (and of course failures) with respect to both technology and regulatory approaches. Since each industry sector e.g. large biopharmaceuticals, CMO’s, academia and organizations such as USP provides differing perspectives it is important to leverage each other’s expertise to everyone’s advantage.
One of the main drivers that we need to address as an industry is the rapidly changing demand for drug supply due to numerous factors including off-label prescribing practices, unexpected drug shortages, incorrect market forecasts and spikes in local population needs. Small footprint, highly modular continuous manufacturing platforms have demonstrated advantages over more conventional brick and mortar batch systems, especially with regards to scalability, flexibility and, for new facilities, shorter design to operation timelines. For these types of systems, production quantities are defined by run time while highly flexible, lighter/smaller reconfigurable equipment modules enable a high degree of adaptability. As a result, continuous manufacturing platforms and facilities are ideally positioned to address supply chain issues, drug shortages and pandemic or natural disaster scenarios, while supporting patient-centric ‘supply on demand’ paradigms. Not only are the equipment platforms reconfigurable, but the potential for entire facilities to be reconfigured on location or relocated to another geographical site is now achievable.
We have seen many examples of companies (e.g. Pfizer, Eli Lilly, Novartis, Merck, Vertex, Lonza) leveraging continuous manufacturing, modular, small footprint equipment trains and flexible facility design concepts into successful API and drug product manufacturing operations in both small molecule and biologics. Efforts to create end-to-end (E2E) manufacturing systems that convert pre drug substance raw materials to final dosage form in a continuous process train are also beginning to gain traction in the industry as it can resolve some current potential hurdles such as API storage and shipment, inventory levels etc.
On June 3 and 4th there is a great opportunity for us all to learn more from a diverse range of experts from industry, academia and regulatory bodies at the 2020 ISPE Continuous Manufacturing Virtual Workshop. The small molecule track at the workshop will focus on sharing the most up-to-date learnings and the factors that have enabled successful implementation for drug products platforms and how these technologies can help drive future strategies and expansion of CM especially for small molecule API manufacturing. The track will also include discussions around E2E continuous manufacturing and true global implementation and alignment. This workshop was initially planned for Boston, MA but with the current global pandemic and consequent travel restrictions, the event has been repurposed as a virtual workshop. Since travel, lodging and in person attendance is no longer required, we are hoping that this exciting event will better accommodate your busy schedule.
The theme of the 2020 ISPE Continuous Manufacturing Virtual Workshop is “A New Decade for Continuous Manufacturing: Current Landscape and Future Opportunities” and seeks to provide attendees with the latest and greatest updates on the status of the industry while discussing future directions for continuous manufacturing for biologics, small molecule API and drug products as well as development in the technologies space to support continuous manufacturing. Additionally, you will be exposed to a virtual network of knowledge experts, innovative development and manufacturing companies and the equipment manufacturers whose technologies are foundational to the cause. ISPE’s goal is to provide attendees with the knowledge needed to help them tackle the technical, regulatory, and organizational challenges on the journey toward manufacturing modernization through the incorporation of continuous concepts and enabling technologies.
This workshop gives us all an opportunity to get together and learn from each other on this great topic that is expected to drive our industry towards the next horizon in this new decade.
We hope to see you online at the workshop!
