Search results for " detection"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Imaged CIEF, or iCIEF, which uses whole-column imaging detection through a charged coupled device (CCD) camera, recently has been commercialized by Convergent Biosciences.24 Although iCIEF is a relati…
Article
Assessing Manufacturing Process Robustness
The database is utilized as a starting point for Stage 3b trending and ongoing signal detection of products that are determined to be robust post assessment.
Statistical analysis (Step 6)…
Article
Reimagining Affordable Biosimilars
Cell-based binding in SPR and BLI takes into account the cell-surface expression of receptors, allowing label-free detection, binding, and saturation events. Recent advances in protein interaction stu…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
In order to provide the purity component found in methods such as CE and cationic exchange chromatography, MAM incorporated a new peak detection feature, Rogers explained, so that differential analysi…
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Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
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Ensuring the Biological Integrity of Raw Materials
Viral contamination is generally the greatest contamination risk because of the ability of viruses to evade detection and cause silent infections in cell cultures. There is no universal, one-size-fits…
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Establishing Acceptance Criteria for Analytical Methods
Parameters that may be evaluated during method development are specificity, linearity, limits of detection (LOD), and limits of quantitation (LOQ), range, accuracy, and precision.”
• USP : “When v…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Optimization of Protein Expression in Escherichia Coli
Affinity tagging
The addition of affinity tags may aid the detection and purification of target proteins. Common affinity tags include poly-His, FLAG, c-Myc, poly-Arg, and StrepII tags. The tag cou…
Article
Tackling Analytical Method Development for ADCs
Free drug issues are typically monitored using reverse-phase chromatography with UV detection, or if the levels of detection must be very low, using LC-MS/MS against a drug linear curve, according to …