Upstream Development

Automated Closed-Loop Solution for Bioreactors and Fermentors

Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…

Cutting Down Process Time and Costs

Because the biopharmaceutical industry operates as an industry rather than a nonprofit, the bottom line is an important consideration in every aspect of product design. From laboratory automation methods that speed discovery to streamlined manufacturing processes that incorporate the themes of operational excellence, Lean manufacturing, and quality by design, the industry is undeniably focused on minimizing cost and maximizing revenue. At the BioProcess International European Conference and Exhibition, the Scale-Up and Manufacturing track will focus on economic strategy and technology…

High-Throughput Process Development

Increasing pipelines, shorter timelines, talent scarcity, reduced budgets — all these are issues faced by companies working in today’s biotechnology environment. The ultimate goal of a process development team is to stay off the “critical path” to drug approval. But how do they complete the necessary work to create a robust manufacturing process in light of such pressures? To increase the effectiveness of development, many companies are turning to high-throughput technologies within their development platforms. Such technologies promise that scientists…

Moving On in Cell Culture

Record-breaking titer outputs in mammalian cell culture systems in the past few years have pushed the industry to a new crisis of sorts: resolving the downstream bottleneck. However, the cell culture and fermentation groups at biopharmaceutical companies aren’t yet ready to sit back and rest on their laurels. Instead, they are moving forward, tackling the downstream issue with upstream modifications and continuing their drive for more cost-efficient processing. The Cell Culture and Upstream Processing track will focus on cell culture…

Automated Closed-Loop Solution for Bioreactors and Fermentors

Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…

PAT Tools for Accelerated Process Development and Improvement

Broadley-James Corporation, Emerson Process Management, and the University of Texas at Austin are working together to examine and quantify the potential for faster optimization of batch operating points, process design, and cycle times. We’re also looking for more reproducible and predictable batch endpoints. The objective of this effort is to show that the impact of PAT can be maximized through the integration of dynamic simulation and multivariate analytics in a laboratory-optimized control system during product development. Data from bench-top and…

A New Era for Bioprocess Design and Control, Part 2

The level or intensity of product and process understanding that can or should be achieved beyond the acceptable minimum level promises to be the scope of a continuing debate among biotech industry and its regulators. In practice, the path of increased understanding may follow a series of incremental steps toward the desired state (Figure 1) after a product launch. Realistically that is expected to occur when the level of product and process understanding has reached or slightly exceeded the minimum…

A New Era for Bioprocess Design and Control, Part 1

Elements of the biopharmaceutical industry’s new operating paradigm have inevitably created an immediate need to condense, interpret, and relate their implications to existing regulatory and industry practices. This also provides us with an opportunity to look at them in a broader context and in relationship to one another. Such a perspective may open up new directions in discussion on how design and control aspects of biopharmaceutical manufacturing are likely to evolve. These are exciting times for scientists, engineers, statisticians, quality…

The Biopharmaceutical Industry’s New Operating Paradigm

Currently the biopharmaceutical industry is transitioning to a new business model of production efficiency through implementing operational excellence (Op Ex). Borrowing from such principles as “lean manufacturing” and “Six Sigma” (6σ), and incorporating quality by design (QbD) (1), Op Ex is being applied through the implementation of such advanced enabling concepts and technologies as quality risk management (QRM) (2), process analytical technology (PAT) (3), and systems biology (SB) (4). Some people see a conflict here: This paradigm shift is occurring…

Carbohydrates and Their Analysis, Part One

A mammalian cell exists, interacts, reproduces, and dies as a result of intricate biochemical and biophysical mechanisms — many of which remain unknown or not fully understood even today. Technological advances have allowed us to investigate the details of organelles and cell membranes, of the types of molecules synthesized within cells, and their distribution and trafficking and the effects they have in their environment. Among the main macromolecules that make up a living cell, DNA and protein structures were studied…