A Novel Affinity Adsorbent For The Capture And Removal Of Endotoxin
Escherichia coli is a Gram-negative bacteria that is a popular host organism for the expression of recombinant protein bio-therapeutics. Lysis of the outer membrane of Gram-negative bacteria, a requirement to release internalised target biomolecules, also releases substantial quantities of lipopolysaccharides (LPS – also known as endotoxin) into the process solution.
WHITE PAPERS & CASE STUDIES
Single-Use Connections Advance Aseptic Processing
In this white paper, John Boehm discusses how single-use connections advance aseptic processing, create increased process flexibility and reliability while reducing costs. By John Boehm, Business Unit Manager, Colder Products Company
Sterilizing Filtration Of Enriched And Pure Gaseous Oxygen Employed In Cell Culture Applications
Modern bioreactor aeration concepts increasingly using oxygen-enriched air or pure oxygen gas to improve cell culture productivity. As with air, these alternate oxygen source gas feeds must be filtersterilized to prevent spoilage of bioreactors by contaminant organisms coming from the incoming and outgoing gas streams. Membrane filters are used to sterilize these gases, and must also be integrity testable to assure process security and meet GMP requirements.
Options For Shortening Integrity Test Time Of Sterile Filters
The integrity testing of sterile filters constitutes a critical and mandatory regulatory step in biopharmaceutical production processes.
Automatic Detection Of Improper Test Setup Of A Filter Integrity System
Filter integrity testing is a crucial requirement in biopharmaceutical production processes. Automatic test units perform indirect tests to verify the pore size to be as specified for a sterilizing-grade membrane filter.
An Environmental Life Cycle Assessment Comparison Of Single-Use And Conventional Bioprocessing Technology
Biopharmaceutical development and manufacturing demand scalable processes that can be smoothly transferred to production. These processes need to be quickly developed and easy to implement.
Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC