Search results for " bioprocesses" in Articles / App Notes

Article Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics. By Susan Haigney Editor's note: The following is an extended version of the…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…

Article Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…

Article Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials. By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biop…

Article Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…

Article Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production. By Jill Wechsler As more biosimilars gain market approval in the United States, and manufacturers launch addition…

Article Mixing dynamics in a large volume single use mixer
Large volume single-use technology mixers can be used for mixing operations throughout the entire bioprocess  workflow. Large-volume mixers are mainly required in clinical three-scale and production…

Article Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality. B…

Article Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict. By Randi Hernandez Demand for any given new product is typically only known after significant investments h…

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