Search results for " detection"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
For example, a high pH anion-exchange chromatography procedure with pulsed amperometric detection (HPAEC–PAD) can be used for the analysis of N-glycans. An example of this can be seen in the N-glycans…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
Quality by Design and Extractable and Leachable Testing
Therefore, a broader range of leachables at lower detection levels is suggested by liquid parenteral or solvent propelled inhalant drug packaging. Table I and Table II from FDA Guidance for Industry, …
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Predicting Progress in Protein Aggregation
One such method is hydrogen deuterium exchange mass spectrometry (HDX MS), which enables the detection of potential sites of aggregation because they are systematically protected from solvent exposure…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Impurity ELISA automation for faster process development
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step can…
Article
Report from the 6th International HTPD Conference
Indeed, even if traditional micro pH probes can measure pH accurately of very small volumes, it is very labor-intensive and existing 96-well plates with fluorescence pH sensors has a very narrow pH de…
Article
Digitalization: The Route to Biopharma 4.0
… pre-processing and analysis, reduce human intervention, automate process control, and perform fault detection to improve process efficiency.
However, there are many attributes such as char…