Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.
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.
Supporting Advances In MAb Process Development And Manufacturing
GE Healthcare is a $17 billion unit of the General Electric Company (NYSE:GE), employing more than 46 000 people worldwide.