2022

Innovations in Cell Culture, Sensor Technology, and Process Control: Preparing for Industry 4.0

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To celebrate the 20th anniversary of BioProcess International, industry suppliers were asked to respond to a questionnaire about the important technologies, trends, and manufacturing innovations that have shaaped their companies and the entire industry over the past two decades. What has been the most important scientific or technological innovation in the past 20 years of bioprocessing? I have been in the industry since the mid-1990s, and clearly the most significant evolution in biomanufacturing has been the widespread implementation of single-use…

August 22, 2022

Bioprocess Monitoring and Control: New and Continuing Needs in the Biopharmaceutical Industry

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Equipment vendors, technology developers, and service providers have played an integral role in promoting innovation in the biopharmaceutical industry, from upstream production to final packaging and distribution of biological products. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Nick Pittman and Magnus Wetterhall of Waters Corporation reflect on advances in — and remaining opportunities for — process analytical technologies (PATs). What Innovations Have Been Most Formative to the Past 20…

August 22, 2022

Proud Partners: Advancing Technologies Enable Collaboration and Innovation

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Recent global events have demonstrated a growing demand for biologics to be made rapidly, cost-effectively, and in high volumes. There has been an urgent need to develop highly flexible and cost-effective next-generation biomanufacturing solutions that provide high yields of therapeutic proteins. Novel technology platforms such as single-use bioreactors and continuous bioprocessing technologies have contributed greatly to improvements in product quality and productivity while reducing cost of goods. Continuous Bioprocessing Expands Historically, continuous-culture processes were used for production of low-titer, low-stability,…

August 22, 2022

Perspectives on Bioseparation and Single-Use Centrifugation

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Although single-use technologies have been part of downstream processing for at least 20 years, single-use centrifugation systems have been developed only in the past decade. They offer significant advantages over traditional centrifugation methods, and suppliers are developing single-use centrifuge lines for shear-sensitive applications. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Tiffany Rau (owner and principal consultant of Rau Consulting) provides her perspective on the breakthroughs in bioseparation and the…

August 22, 2022

20 Years of Advancements in Bioseparations

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Over the past 20 years, the biopharmaceutical industry has made significant advancements in the way that biopharmaceuticals are produced. That principally has been driven by innovative new therapies and demands for greater availability of affordable biotherapeutics. Although the industry has made numerous performance improvements from cell line development and protein expression to bioseparations, downstream processing has presented the industry with its greatest obstacles. For efficient processing and improved yields, step yields should be high (preferably >95%), and the number of…

August 22, 2022

Empowering the Next Revolution

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Over the past 20 years, the bioprocessing landscape has undergone multiple transformations. Some of those were driven by biological innovations as new therapeutic platforms and modalities were introduced; others were driven by advancements in engineering and applied technologies such as single-use solutions, automation, and artificial intelligence. But the industry’s mission of making life-saving medicines that are effective, safe, and affordable remains the same. It’s rewarding to work in a field that aims to improve people’s health and life expectancies and…

August 22, 2022

Host-Cell Protein Analytics: History and Future Trends

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Different analytical methods have been developed to detect host-cell proteins (HCPs) in bioprocess streams. Advancements in such methods are enabling biomanufacturers to optimize their purification processes and ensure that their products are safe and efficacious. To celebrate the 20th anniversary of BioProcess International, Ken Hoffman (founder of Cygnus Technologies) provides insights into the history, trends, and future of HCP analytics. History: 1990s to 2022 The recombinant therapeutic protein industry was in its infancy in the early 1990s. HCPs were recognized…

August 22, 2022

Challenging the Norms of Facility Design and Innovation

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The past 20 years have spurred new technologies that enable flexible solutions to changing market demands. Small-scale tools, improved analytical methods, and innovative facility designs are among the notable breakthroughs. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Elyse Vlahos (director of process engineering at Genesis AEC) provides her perspective on innovation and future industry developments. Innovation and Regulations What have been the most important technical innovations over the past…

August 19, 2022

Turn-Key Biopharmaceutical Solutions for Next-Generation Facilities

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One of the most impactful innovations over the past 20 years of biopharmaceutical production has been the digital transformation of manufacturing processes. As executives of a solution provider for the pharmaceutical and biotechnology industries, we have witnessed the ongoing evolutions and applications of digital technologies. When digitalization is applied intelligently, time to market is shortened, and engineering, construction, commissioning, and qualification activities are accelerated. Digital platforms enable the aggregation of massive amounts of data derived from different sources such as…

August 19, 2022

Continuing Commitments to Quality Reflections on Contract Manufacturing Organizations and Success in the Biopharmaceutical Industry

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Nick Green has worked in the global pharmaceutical and healthcare-services industries for more than 35 years, including significant experience with third-party manufacturing of biological products. He currently serves as president and chief executive officer (CEO) of Avid Bioservices, a contract development and manufacturing organization (CDMO) that focuses on biopharmaceuticals derived from mammalian cell cultures. He has held senior leadership positions at several life-science companies. That includes time spent as president and CEO of Therapure Biopharma, Evolve Biologics, and Rhodia Pharma…

August 19, 2022