Search results for "biopharm"
Article
Reconciling Sensor Communication Gaps
Techniques that quantify some over-arching characteristic come to mind—such as refractive index in the chemical-pharmaceutical world—but the quality attributes for biopharmaceutical molecules are so m…
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Evaluating E&L Studies for Single-Use Systems
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biopharmaceutical companies have increased the adoption of single-use systems (SUS) and components (i.e., polyethylene bag…
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The Tide Stays High
Nevertheless, fundraising by emerging biopharma companies held its own in 2016. Financing for emerging bio/pharma from venture capital, public equity, and partnering sources was ahead of 2013 levels, …
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Improving Process-Scale Chromatography
By Cynthia Challener, PhD
Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a significant portion of downstream processing efforts (time and cost) for bio…
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Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
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Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
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Modeling Bioreactor Performance
Why model bioreactor performance?
There are many reasons why biopharmaceutical manufacturers invest in the development of bioreactor modeling capabilities. Modeling is used to gain insight into no…
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Innovation vs. Capacity: How CMOs Compete
Perhaps the biggest is the reduced propensity of global bio/pharma companies to outsource manufacture of their newest products, especially biopharmaceuticals. New product approvals earned by global bi…
Article
Perfusion in the 21st Century
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three decades. Batch processing, in which all raw materials are introduce…
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Downstream Processing Continues to Worry CMOs
…pear to show any signs of abating, according to BioPlan Associates 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
(1). In fact, nearly two-thirds (64%) o…