During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery. High titers are often obtained from Human Embryonic Kidney (HEK) 293 derived cell types; however, the use of different host cells between early stage transient and later stable protein production is a concern and can lead to the advancement of false-positive candidates. Chinese hamster ovary (CHO) cells are a desirable target cell type due to growth characteristics and a history of regulatory approval;…
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Process economy and production capacity: Comparing single-use and stainless steel strategies for microbial fermentation
In recent years, single-use technology has been migrating into many unit operations. With the commercial availability of such systems end users have a new option for process development and production that does not rely on operational complexities and utility requirements of conventional sterilize-in-place (SIP) or autoclavable systems. However, just as for cell culture processes, single-use technology may not apply to each and every fermentation or microbial process. It is the responsibility of practitioners to properly assess their own applications, select…
High Performance Cell Retention Technology for Cell Culture Process Intensification
This webcast features: Millie Ullah, PhD, Associate Director of Upstream Product Management and Marketing, Repligen The move toward continuous processing and intensified processes is a paradigm shift in bioproduction. In upstream cell culture, the challenge is to simplify and minimize process steps (N-1 perfusion) while intensifying cell retention and viability (high density cell expansion). This webcast will present a case study where use of the ATF cell retention system in process intensification of a fed-batch culture resulted in successful N-1…
An Extractable and Leachable Program for Assessing Single-Use Components and Systems
This webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences. Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while…
Refolding of Biopharmaceuticals by FOLDTEC: A Case Study on Recombinant Thrombin
This webcast features: Dr. Andreas Anton, Director Bioprocess Development and Dr. Sebastian Schuck, Senior Manager Business Development, Wacker Biotech While WACKER’s own technology ESETEC® has proven highly efficient in producing soluble proteins and antibody fragments via secretion, poorly soluble substances form aggregated inclusion bodies within the cell, which contain incorrectly and/or incompletely folded target proteins. Recently Wacker Biotech introduced FOLDTEC®, its novel refolding technology for bioengineered pharmaceutical proteins. With this new technology, biopharmaceuticals that tend to aggregate can be efficiently…
Downstream Processing – Interview with Thomas C. Ransohoff
BioProcess International editor in chief Anne Montgomery interviewed Thomas C. Ransohoff, vice president and principal consultant, BioProcess Technology Consultants, at the BPI Conference and Exposition in Boston, MA, in October 2015. Sponsored by Click here to view the other videos in this series.
Downstream Processing – Interview with Pete Gagnon
BioProcess International editor in chief Anne Montgomery spoke with Pete Gagnon, Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore, at the BioProcess International Conference and Exposition in Boston, MA, October 2015. Sponsored by Click here to view the other videos in this series.
Downstream Processing – Interview with Giorgio Carta
BioProcess International editor in chief, Anne Montgomery, interviewed Giorgio Carta, Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia at the BioProcess International Conference and Exposition in Boston, MA, in October 2015. Sponsored by Click here to view the other videos in this series.
Increased Monoclonal Antibody Resolution with TSKgel® UP-SW3000 Columns
The antibody therapeutics market is enjoying high growth rates, the major areas of therapeutic application being cancer and immune/inflammation-related disorders including arthritis and multiple sclerosis. In 2013, six of the top ten best-selling global drug brands were monoclonal antibodies (mAbs) and more than 400 mAbs were in clinical trials. The characterization of these complex biomolecules is a major challenge in process monitoring and quality control. The main product characteristics to be monitored are aggregate and fragment content, glycosylation pattern and…
Downstream Processing – Interview with Dr. Carsten Voß
BioProcess International editor in chief Anne Montgomery spoke with Dr. Carsten Voß, application specialist, Process Chromatography, Bio-Rad Laboratories GmbH at the BioProcess International Conference and Exposition in Boston, MA, October 2015. Sponsored by Click here to view the other videos in this series.