Search results for " techniques" in Articles / App Notes
Article
Analysis of Glycosylation in Biosimilars
This leaves released, derivatized carbohydrates, which is advantageous in each of the three mass spectrometry-based analytical techniques used to determine the glycosylation pattern.
In matrix-ass…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
ICH Q5B (14) recommends that, “segments of the expression construct should be analyzed using nucleic acid techniques in conjunction with other tests performed on the purified recombinant protein for a…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
Article
Mapping a Route for Cell and Gene Therapy Process Development
The ability to generate and manufacture well-characterized batches of cells for therapeutic use requires significantly different approaches to typically implemented laboratory-based cell-culture techn…
Article
Methods Accelerate Biosimilar Analysis
Focus is placed mainly on high-resolution mass spectrometry (HR-MS) for primary structural analysis and characterization of post-translational modifications and various biophysical techniques for high…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
LCGC, “A Trio of Techniques on the Road to Complete CQA Characterization,” LCGC Chromacademy ebook,(March 2019).
3. M. Adkins, “In-Line Monitoring and Real-Time Release,” presentation at INTERPHEX…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
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Surface sampling recovery studies
Surface sampling recovery studies using swabs, wipes, or direct sampling techniques should be performed as part of the design stage to …
Article
N-Glycan Analysis of Biotherapeutic Proteins
In this article, the biological effects of N-glycosylation on protein biologics are reviewed—together with the range of analytical techniques that are used to elucidate the N-glycosylation characteris…
Article
Managing Residual Impurities During Downstream Processing
There are several implications of these documents, according to Wake, but on a practical level they require industry to replace traditional wet chemistry techniques for heavy-metal determination with …
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …