Author Archives: Brian Gazaille

eBook: Formulation, Fill–Finish — Biopharmaceutical Drug-Product Trends and Technologies

As with many other aspects of biopharmaceutical development, evolving technologies are transforming drug-product development and manufacturing. In a November 2020 report on the Informa Connect “Drug Delivery Partnerships” meeting, BPI senior technical editor Cheryl Scott reviewed how new delivery-device technologies are bringing together companies with disparate expertise to serve patients with chronic conditions better than ever before. The ever-increasing capabilities of electronics and information technology (IT) not only are enabling development of “smart” delivery devices, but also improving the potential…

eBook: Biomarkers — Improving Clinical Studies to Enhance Commercial Success for Biologics

The biopharmaceutical industry continues to invest heavily in technologies for identification of predictive biomarkers. Drug developers want not only to find quantitative evidence that their therapies will work as designed, but also to anticipate which patient populations will respond positively to those regimens. Doing that could streamline clinical trials, accelerate approvals, and ultimately improve patient outcomes. Advances in next-generation sequencing and increases in computational capability now are facilitating biomarker inquiries, especially in the realm of immunooncology. However, predictive biomarkers remain…

November–December 2020:
From the Editors

As 2020 draws to a close, we can’t help looking back at this year in which the biopharmaceutical industry has received more attention than ever before — scientifically, politically, and otherwise. We editors always have been conscious of (and pretty good at) separating our work and home lives. As many of you have learned this year, that’s an important part of working from home, which we’ve been doing for over a decade. But in recent months, reading the news and…

Plant-Cell Cultures and Cell Lines for Recombinant Protein Expression

Cell cultures derived from mammalian and bacterial cell lines are the conventional production systems in bioprocessing. But they also have their limitations. Media for mammalian cultures in particular are notoriously expensive, and traditional cell cultures can be highly sensitive to growing conditions. During the late 1980s and into the 1990s, plants and plant-derived cell cultures were introduced as alternative cell-culture systems (1, 2). Although transgenic plants (genetically modified) once looked promising in the early 2000s, the cost and manufacturing complexity…

Developing Advanced-Therapy Products Through Global CDMOs

Tremendous growth in the cell and gene therapy (CGT) industry is driving unprecedented demand for manufacturing services. To be sure, advanced-therapy developers increasingly are choosing to install in-house capabilities. Doing so can offer companies greater control of their processes, timelines, and budgets than they might have when outsourcing products (1). But industry experts agree that contract development and manufacturing organizations (CDMOs) will remain integral to CGT manufacturing and commercialization (1, 2), especially with veteran contract partners scrambling to acquire CGT…

eBook: Expression Systems — Innovative Techniques for Conventional Cell Lines

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…

Soft Sensors for Bioprocess Monitoring

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…

Better Bioprinting Ahead: Breakthroughs and Remaining Challenges

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…

eBook: Joining Forces — Industry Collaborations Toward BioProcess Success

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…

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

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…