Search results for " identity"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
CoAs Help Secure the Supply Chain
It should also have the identity and signature of the person who approved the certificate along with the date of approval. The World Health Organization (WHO) has a document on their website titled, “…
Article
Impurity Testing of Biologic Drug Products
The requirement to establish an analytical method depends on whether it is for an identity test, content test, or purity/impurity test; whether it is for release, in-process testing, or characterizati…
Article
QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
Article
Analysis of Glycosylation in Biosimilars
If the eluent is first passed through a fluorescence cell, and then into a mass spectrometer, information about the identity can be obtained, as well as the relative quantities of the different glycan…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Mass spectrometry (MS) can be used to establish the identity of the drug (primary sequence) and for detection of size-distribution profiles linked to post-translational modifications such as glycosyla…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
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…