Facility Design/Engineering

Large-Scale Capacity Strategies: Single Use, Multiuse, or Both?

Early manufacturing facilities for large-scale production of biopharmaceuticals were, by necessity, very large. Low expression titers and blockbuster-market products such as monoclonal antibodies (MAbs) combined to require massive bioreactors — with capacities of 10,000– 20,000 L or more — and supporting infrastructure. In my early days covering the industry, I visited a few such facilities and was always awed by the huge tanks and what seemed like miles of piping. A 2010 Pharmaceutical Engineering article described a process modeling approach…

Biomanufacturing Scenarios: From the Biomanufacturing Technology Roadmap

Drug Substance Scenarios Given the complexity of the biopharmaceutical industry and the increasing diversity of products and companies, it is clear that there will be no “one size fits all” solution to biomanufacturing. Instead, we see a range of biomanufacturing scenarios playing out over the next 10 years. Five high-level scenarios were selected for drug substance manufacturing and two for drug product to cover the full spectrum of process and facility types. Each facility type is associated with a representative…

Opportunities for Modern Robotics in Biologics Manufacturing

It should come as no surprise to anyone familiar with biomanufacturing that current designs of bioprocess facilities as well as associated manufacturing spaces and support operations require excessive amounts of manual labor and manual interventions that lead to high labor costs and, consequently, total cost to supply. From receipt of raw materials to process execution and performance review, resolution of quality issues, and product shipping, no industry devotes a greater percentage of operating costs (or cost of goods sold, CoGS)…

Computational Science Changes Biolaboratory Design

Until relatively recently, life-science research was characterized by test tubes, Petri dishes, and centrifuges. Now, as with many industries, the life sciences are undergoing a digital transformation. Computational science is changing laboratory design. The healthcare industries always have generated large amounts of data. What has changed is the available information technology. With the growth of cloud computing, large data sets — and the high-speed tools for analyzing them — are available increasingly to a degree not possible with traditional servers…

Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board

While the growth in biopharmaceutical manufacturing capacity in developed, major market countries is continuing its slow and steady climb, developing regions often are seeing double that growth rate. Over the past eight years, as detailed in the “About the Data” box, our company’s index of the top 1,000 biomanufacturing facilities (1) has tracked and ranked bioprocessing facilities worldwide in terms of known or estimated bioprocessing capacity (cumulative onsite bioreactor volume) number of biological products manufactured at clinical scale commercial scale…

Designing Laboratories for Flexibility and Collaboration

The blockbuster business model may have paid off in the past, but tomorrow’s biopharmaceutical successes will depend more on rapid and diverse discovery than on any single breakthrough. In the race to get new therapies from research and development (R&D) into pharmacies, next-generation laboratory space could become a game-changer. Blockbuster drugs typically were made in industrial laboratories — and industrial-strength measures were required to reconfigure those spaces as new research priorities emerged over time. Facing changing patient needs and ongoing…

Capacity Strategies: The Strategies Behind Choosing Between Large-Scale and Single-Use Investments

Moderator Dan Stanton, with Weichang Zhou, Jenifer Wheat, Roger Lias, and Jim Vogel Single-use technologies (SUTs) are now prevalent within bioprocessing, but does this spell the end of industry’s historic reliance on stainless steel and fixed facilities? This roundtable was formed to discuss the wealth of investment in single-use (SU) equipment and flexible manufacturing solutions by contract development and manufacturing organizations (CDMOs) over the past few years, pitting that against what looks like a resurgence in fixed-cost stainless steel plants…

Facilities of the Future: Intelligent Design and Control Enable Quality, Efficiency, and Good Citizenship

Today’s biomanufacturers need to be able to add capacity and capability quickly; provide increased supply service to customers on demand; and streamline the flows of personnel, traffic, utilities, and materials throughout bioprocess facilities. And companies need to be flexible enough to subtract capacity and retool quickly to produce new or different products. Many future facilities will be automated to some extent and use robotics in manufacturing. With personalized medicine on the rise, bioprocessors can benefit from colocation with academic research…

Flexibility, Automation, and Leadership: Drug-Sponsor Perspectives on Modern Biomanufacturing Facility Design

The title of this featured report — Smart(er) Facilities — came about in conversations with our KNect365 colleagues as they worked to plan this year’s BPI West conference, which took place 19–22 March 2018 in San Francisco, CA. For decades, biopharmaceutical facilities have incorporated cutting-edge designs for supporting processes, products, and human development. Each year, design innovations are rewarded for creating workspaces that facilitate both worker comfort and essential movement of promising drug candidates toward commercialization. In that context, biomanufacturing…

Partnerships for Progress: Supplier Perspectives on Facilities of the Future

Biomanufacturers are constantly tasked with making their products ever more efficiently with ever increasing quality. As major advancements come in biomanufacturing technology, companies find themselves in need of “smarter,” more flexible facilities than ever before. Recently, I asked several industry leaders for their thoughts on some criteria for smarter designs, including why there is such a demand: Cristina Amorim (vice president of facilities, EHS, and sustainability in the life sciences group of Thermo Fisher Scientific) Scott Battist (vice president, general…