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T-Cell Suspension Culture in a 24-Well Microbioreactor: High-Throughput...
Cell therapy promises revolutionary new therapeutic treatments for cancer and other serious diseases and injuries. For example, T-cell therapy response rates of >50% and durable complete response...
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Meeting Lot-Size Challenges of Manufacturing Adherent Cells for Therapy
Adherent cells such as adult primary cell lines and human multipotent (MSCs) and pluripotent stem cells (hPSCs) present a manufacturing challenge as lot sizes increase from 109 (billions) to 1012...
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Fluid Dynamics of a Single-Use, Stirred-Tank Bioreactor for Mammalian Cell...
Photo 1: Pall Allegro STR bioreactor The benefits of single-use technologies in both upstream and downstream operations are now widely acknowledged by the biopharmaceutical industry, and have led to...
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Cost-Effective Process Development for Plasmid DNA Manufacture: Evaluation of...
Figure 1: Development of production process for manufacturing plasmid DNA DNA-based gene therapy products have been in clinical development since the 1990s. But over the past 24 months, the overall...
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Special Report: Turning Discoveries into Products — Developability...
High costs and long timelines for biopharmaceutical development are cause for reflecting on how best to allocate resources from the earliest discovery stage through critical go–no-go junctures. With...
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Experiences with a Benchtop-Scale Glass Bioreactor: Engineering Data and...
Photo 1: SmartGlass bioreactor with the G3Lab Universal controller Animal cell lines (the dominant expression systems in biopharmaceutical production processes) are mostly cultivated in stirred...
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Development, Qualification, and Application of a Bioreactor Scale-Down...
GRAPHIC STOCK (WWW.GRAPHICSTOCK.COM) Qualified scale-down models of large-scale cell culture processes are essential to conducting studies for applications such as investigating manufacturing...
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The Case for a Standardized Assay to Test Suitability of Single-Use Systems...
Fotoproduktion bei Sartorius, Göttingen vom 04.12.-10.12.11 Increased commercial use of single-use systems (SUS) for large-scale biopharmaceutical production creates the need for consensus on industry...
View ArticleProcess- and Product-Relate Impurities: Part 1 – Process-Related Impurities...
Introduction by Cheryl Scott The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative...
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Multivariate Analysis of Biological Additives for Growth Media and Feeds
Biological additives such as yeast extracts and peptones are commonly used in growth-media formulations for biopharmaceutical manufacturing. In spite of drivers encouraging companies to reduce...
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Evaluating New Film for Single-Use Bags: Growth Performance Studies with...
SARTORIUS STEDIM BIOTECH (WWW.SARTORIUS.COM) In biopharmaceutical development and manufacturing processes, single-use technology has become widely accepted (1). Storage and cultivation bags are...
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Orbital Shaking and Acoustic-Resonance Mixing: Comparing Culture Characteristics
A YouTube video shows the RAMbio mixing system in action. (WWW.YOUTUBE.COM/WATCH?V=AFUE56BV85G) Production of recombinant proteins usually happens in suspension cultures, with oxygen limitation playing...
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Special Report on Continuous Bioprocessing: Upstream, Downstream, Ready for...
Once an engineering curiosity and smallscale laboratory technique, continuous bioprocessing has evolved in just a few short years to a topic of intense and increasing interest to most bioprocessors....
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Quality By Design for Monoclonal Antibodies, Part 1: Establishing the...
The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to...
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Rapid Development of High-Quality, Robust Mammalian Cell Culture...
Figure 1: Tools for speed to clinic With increasing industry emphasis on providing both rapid and robust processes, companies are reaping the benefits of new tools for risk management and process...
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Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and...
Figure 1: A design space plot as determined by Jiang et al. for a hydrophobic-interaction chromatography (HIC) step used to purify an Fc fusion protein (4). This example shows the acceptable design...
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Emerging Technology Trends in Biologics Development: A Contract Development...
For a contract development and manufacturing organization (CDMO), process development and manufacturing of recombinant proteins must be linked because of tight timelines driven by client expectations....
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Advanced Protein Engineering Enhances Biopharmaceutical Manufacturing and...
Figure 1: Core protein engineering technology; scaffold protein is shown in yellow, and the fused protein of interest (e.g., cell-adhesion protein, enzyme, or single-chain antibody molecule) is shown...
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Providing Lipids Boosts Protein Productivity: Testing a Feed Supplement with...
GRAPHIC STOCK (WWW.GRAPHICSTOCK.COM) As the biologics (and now biosimilar) markets continue to grow, pressure increases on biomanufacturers to reduce cost of goods sold (CoGS). One way they can reduce...
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Continuous Cell Culture Operation at 2,000-L Scale
In the biopharmaceutical industry, continuous manufacturing is often cited as a method for increasing the productivity of bioprocesses (1). Compared with batch processing, it has the potential to...
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