The biopharmaceutical industry is undergoing a paradigm shift in manufacturing. At the core of this evolution are definitions of scale and materials of construction. Options that at first seem mutually exclusive — multiuse, cleanable equipment based on stainless steel and single-use disposable equipment based on polymer films — actually could complement each other in combination approaches to large-scale manufacturing. In this featured report, authors from user and supplier companies review a number of strategies available for innovators and biosimilar developers making antibodies and their derivatives, other proteins, vaccines, gene and cell therapies, and beyond for the global biopharmaceutical market of the future.
Large-Scale Capacity Strategies: Single-Use, Multiuse, or Both?
Classic large-scale facilities based on stainless steel equipment are still up and running around the world, some making products that are approaching their patent-expiration dates. Developers of their would-be biosimilar competitors are designing new facilities based on new strategies for meeting uncertain demand. Meanwhile, many biopharmaceutical companies are working on next-generation biologics for the worldwide healthcare market of the future. The biomanufacturing facilities that make those new products are likely to look very different from the “tank-farms” of the past. But different in what way? The senior technical editor reviews current trends in large-scale capacity strategy.
Continuous Manufacturing: A New Approach to Process Scale
Mark Brower, Charlie Heise, Graeme Moody, and Clare Simpson
Continuous bioprocessing has been proposed as one future biomanufacturing state because it operates at similar scales for both clinical and commercial production using flexible facilities that can react readily to changing market pressures. Authors representing the BioPhorum Operations Group (BPOG) preview an upcoming paper that identifies a number of gaps hindering the implementation of continuous downstream drug-substance biomanufacturing for clinical or commercial production of therapeutic proteins.
Biomanufacturing Scenarios from the Biomanufacturing Technology Roadmap
The BioPhorum Operations Group
Process modeling described in the first-edition BPOG biomanufacturing technology roadmap described manufacturing scenarios of the future. The authors highlight areas of opportunity in which technology acceleration can break through process bottlenecks. This excerpt describes that modeling work and conclusions drawn while identifying opportunities for future analysis for five strategies: large-scale stainless steel fed-batch; intermediate-scale single-use perfusion; intermediate-scale multiproduct single-use fed batch; small-scale portable facilities; and smaller scale personalized medicine manufacturing.
A Shift of Mindset: How Single-Use Systems Influence Bioprocess Engineering and Process Execution
Jan Schäfer, Michael Koch, Stefanie Beck, and Jens Landmann
Single-use technologies have changed how biomanufacturing plants are designed and constructed. The requirement for much more flexible layouts with ballroom and dancefloor concepts has led to facilities being constructed around process specifications. Mass balance, material flow, automation integration, and data analytics all need to be considered in different ways. The amount, types, and scale of SU technologies have changed and increased significantly, adding an extra burden on facility design and operations. Here, authors from Sartorius Stedim Biotech suggest some possible solutions.