Stirring The Mix Of Single-Use Mixers
Mixing is an essential operation within biopharmaceutical manufacturing and is required for processes involving suspension, dispersion, dissolution, and homogenization. By Jerold Martin Sr. V.P., Global Scientific Affairs, Pall Life Sciences
WHITE PAPERS & CASE STUDIES
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.
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
Automated pH Adjustment In An Intelligent Single-Use Mixing Platform
Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.
Inside BioPharma: A Closer Look At Filter Housings
Although traditional stainless steel equipment has lost a great deal of market penetration to single-use alternatives over the past decade, there still is a need for quality filter cartridge systems for sterilizing and polishing filtration processes. By Leon VanWormer, MBA, Sartorius Stedim Biotech