Author Archives: Brian Gazaille

eBook: Expression Systems — Innovative Techniques for Conventional Cell Lines

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Although Chinese hamster ovary (CHO) and Escherichia coli cells have become the biopharmaceutical industry’s preferred platforms for producing recombinant proteins, perennial challenges have limited the capabilities of those expression systems. New CHO lines and improved upstream methods steadily are increasing expression titers, yet researchers continue to decry CHO’s relatively low growth rate. E. coli exhibits strong growth kinetics but cannot perform posttranslational modifications necessary for complex therapeutic proteins. Researchers need advanced technologies and analytical methods to overcome such limitations. This…

July 23, 2020

Soft Sensors for Bioprocess Monitoring

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Achieving the high process efficiencies and optimization of Manufacturing 4.0 will require sophisticated software systems, mathematical modeling, and on-line process monitoring. Soft sensors are valuable tools that enable users to measure process parameters in real time. I spoke with Benjamin Bayer, data scientist at Novasign GmbH and doctoral candidate at the University of Natural Resources and Life Sciences in Vienna, Austria, about the potential of soft sensors for bioprocessing and important considerations for their use. Introduction How would you describe…

May 28, 2020

Better Bioprinting Ahead: Breakthroughs and Remaining Challenges

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Bioprinted organs soon could revolutionize clinical trials, transplantation, and regenerative medicine. But as Chris Lo reminds us in a new GlobalData report (1), several technical hurdles must be negotiated before biopharmaceutical companies can harness three-dimensional (3D) bioprinting for such purposes. BPI explores persistent printing problems and promising solutions below by analyzing Lo’s report alongside commentary from founding editorial advisory board member Bill Whitford (bioprocess strategic solutions leader at GE Healthcare Life Sciences), Lev Gerlovin (vice president in the life sciences…

March 3, 2020

eBook: Joining Forces — Industry Collaborations Toward BioProcess Success

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Companies in the biopharmaceutical industry increasingly are working together to solve the many challenges of product/process development and biomanufacturing. Suppliers seek end-user help in refining technologies; academics and small innovators attract the financing and business acumen of large companies; equal partners share in technological problem-solving; and sponsors engage the development expertise of contract research and manufacturing organizations. Other examples of biopharma industry collaborations abound, too. Citing critical examples from the September 2019 BioProcess International East Conference in Boston, MA, this…

January 28, 2020

eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

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Although today’s vaccines are safer, more effective, and more accessible than they were even 20 years ago, the emergence of new, complex pathogens has exposed limitations in traditional vaccine strategies. Viral vector vaccines (VVVs) hold great promise for confronting those now-intractable pathogens. Combining the best features of live-attenuated and DNA-vaccine approaches, these next-generation prophylactics seek to harness the infectivity of non- or low-immunogenicity viruses to shuttle antigen-encoding DNA from target pathogens into host cells. The resulting transduced cells then initiate…

December 19, 2019

eBook: Addressing Production Complexities — Strategies for Working with Difficult and Susceptible Proteins

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All proteins are complex — but some are more complex than others, particularly when it comes to recombinant protein expression and production in commercial quantities. What works in a research laboratory to make a milligram of pure protein for study won’t necessarily work on a manufacturing floor to make kilogram batches for drug-product formulation. An increasing number of technological options are available, however, from a simple switch in expression host or adding folding steps in downstream processing to special genetic…

November 20, 2019

BioProcess International 2019 Event Report

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The 2019 BioProcess International Conference and Exhibition, held in Boston, MA from 9–12 September, was a testament to the rapid expansion of the biopharmaceutical industry. Nearly 150 speakers chronicled recent developments and continuing challenges in upstream production, downstream processing, drug product manufacturing, and emerging therapies production. And with more than 150 poster presentations and over 200 companies participating, the BPI exhibit hall never better embodied the industry’s efforts to support increasingly diverse but related audiences. In this event report, BioProcess…

November 14, 2019

eBook: Bioreactor Scale-Up: From Pilot to Commercial Scale in the Modern Era

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Upstream bioproduction always has begun with laboratory systems producing limited amounts of product for test purposes, then those bioprocesses are scaled up to make more product more efficiently for larger clinical trials — and ultimately commercial distribution. With the advent of single-use technology and continuous processing, how have scale-up approaches changed in recent years, specifically at the pilot-to-production level? In this online exclusive, BPI editors review the science and technology affecting decisions made at this stage of process development, with…

September 27, 2019

eBook: Autologous Cell Therapies: Commercialization Strategies

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Autologous cell therapies are derived from a patient’s own stem cells, typically collected from bone marrow. Those cells are then cultured, expanded, and reinfused back into the patient. Unlike allogeneic cell therapies, this process is repeated for each dose and for one patient. The one-to-one process carries several challenges to commercialization, including high development costs, the need to control the risks of manual processing, and compliance with strict timelines. This eBook presents two perspectives on addressing these challenges. The first…

September 26, 2019