Culture Development White Papers and Case Studies
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Improving DNA Removal from Bioprocess Purification Processes
Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.
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Removal Of Host Cell Proteins During Monoclonal Antibody Purification
Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc
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Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes
Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.
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Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations
This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific
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The Next Generation Drug Delivery Devices
An exciting trend in drug delivery is the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by technological advancements driving the consumer electronics market, new drug-delivery methods show promise for all stakeholders.
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Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess
The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.
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Multivariate Data Analysis For Biotech and Bioprocessing
The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.
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The Challenges With Real-Time Viable Particle Counters
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators.
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The Role Of Biological Indicators For Hydrogen Peroxide Vapor Technology
Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapor (HPV) decontamination efficacy. By Dr Lynne Murdoch, Bioquell UK Ltd
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Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products
The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, which enables you to establish or modify recommended storage conditions, retest periods, and shelf life or dating period, as the case may be.