DOWNSTREAM PROCESSING FEATURED ARTICLES
CDER-ETP: A Resource For Innovative Biopharma Firms
The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development.
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Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 2
Industry experts offer the benefits of standardized single-use equipment to both suppliers and users, as well as how it addresses some of the biggest objections to equipment standardization, as well as offer insight from the eyes of a user.
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Elusys Awarded Additional $14.5 Million Under Existing U.S. Government Contracts Supporting Expanded Human Safety Studies Of ETI-204 For Treatment Of Inhalational Anthrax
Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing countermeasures for biodefense, announced today that it has been awarded additional funding from the U.S. Government, valued at $14.5 million, to support expanded human safety studies of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack.
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Launch Of A New Protein A Chromatography Resin For Purification Of Antibody Drugs
Kaneka Corporation (Osaka, Japan; President: Kimikazu Sugawara ) announces the launch of KANEKA KanCapA, a new Protein A Chromatography Resin for the purification of therapeutic antibodies. 'KANEKA KanCapA' exhibits high antibody adsorbing capacity and alkaline resistance.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
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Biomanufacturing Complexity
This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.
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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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How CHT Ceramic Hydroxyapatite Works Application Note
CHT ceramic hydroxyapatite is a versatile chromatography support used for separation of biological molecules as diverse as polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. By Paul Ng, Jie He, and Andrew Cohen, Bio-Rad Laboratories, Inc., Hercules, CA 94547
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Biomanufacturing Flexibility
This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.
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Automating Protein Purification Processes Achieves Reliable Results And Reproducibility
ÄKTA start is an easy-to-use, reliable protein purification system. In this application note it is described how Erica, a post-doctoral researcher, used ÄKTA start to purify GST-tagged protein using a predefined method template, a GSTrap FF column, and a Frac30 fraction collector.