Search results for " detection"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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The Development and Application of a Monoclonal Antibody Purification Platform
The percent monomer is determined by size exclusion high performance liquid chromatography, using two G3000 SWXL columns (Tosoh, Montgomeryville, PA) in series with detection of the antibody at 214 nm…
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A Closer Look at Affinity Ligands
Affinity ligands can be used for various purposes, such as detection, purification, or modulation of biological activities. Affinity chromatography is a separation method based on the specific binding…
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Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
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News: Cytiva Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
Cytiva is pleased to announce the new Amersham HCPQuant CHO kit, a generic for detecting host cell protein impurities in drug samples produced in CHO cell lines.
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Fluorescently labeled N-glycans are commonly analyzed by separation using high- or ultra-high-performance liquid chromatography (HPLC or UHPLC, respectively) coupled to fluorescence detection (FLR), o…
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Putting Viral Clearance Capabilities to the Test
“There is always a lower limit of detection, so the virus infectivity may be greatly reduced, but never to zero. Not all viruses are known. We will find what we look for but may miss the unexpected.” …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Lopolito, “Cleaning Agent Residue Detection with UHPLC [7]” Pharm. Manufacturing (April, 2013), accessed Oct. 10, 2017.
18. R. L. Forsyth, J.C. O’Neill, and J.L. Hartman, Pharm. Tech. 31 (10) 1…
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Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The nucleic acid sequence of the predominant transgene transcripts should be identical—within the limits of detection of the methodology—to the expected sequence encoding for the protein.
In summar…