Search results for " name" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
One example is a HCP named GST-α. GST-α causes no or low immune response in the animals being immunized and thus doesn’t generate an antibody in the polyclonal antibodies used for HCP ELISA. However, …
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
A recent reported example showed that the oxidized form of the organophosphite secondary antioxidant tris(2,4-di-tert-butylphenyl)phosphite (TBPP, often referred to under the trade name Irgafos 168) u…
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New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
The key PAT concepts, namely real-time product quality-based decision making, is central to success of a continuous manufacturing program.
Read More Q&As With Industry Leaders Here
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Challenges of Protein Aggregation During Purification
The technology was developed at the University of Colorado and is currently marketed by BaroFold under the name Pressure Enabled Protein Manufacturing (PreEMT) technology. In January 2013 and November…
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Trends in BioPharma Approvals in 2013
This total, however, represents a comparatively more modest 10 genuinely different products, as several are marketed under two or more trade names, but with each possessing its own marketing authoriza…
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Design of Experiments for Analytical Method Development and Validation
Analyst name, equipment ID, out time, hold times, ambient temperature, temperature at the beginning and end of an operation, transfer times, pH, and incubation time may hold valuable information on fa…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Attributes that are not critical to quality are sometimes named process performance attributes to distinguish from quality attributes.
Not all CQAs are tested as part of finished-product testing. …
Article
Supplier-Change Management for Drug-Product Manufacturers
…turing, testing, and warehousing among others)
• Change in ownership
• Change in company name
• Use of a new subcontractor for purchased materials or services
• Change in certificatio…
Article
Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…