Search results for " stability" in Articles / App Notes
Article
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The primary objective of the screening is to obtain the most promising starting conditions with respect to overall selectivity, peak shape, and chemical stability, as well as minimal reliance on accur…
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Medium storage stability is a general concern for manufacturing and development using concentrated feed media. In this study, the 2.50X + 0.5% P188 M1 and 1.33X M2 media have a shelf life of 60 days a…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
EMA Collaborates with HTA Assessment Networks
Quality Issues
In Denmark, selection of biosimilars available in the country’s health service is based not just on price but quality issues like stability, according to Walsh. This has helped to ov…
Article
Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
If its level does not increase in the process or on stability testing, the occurrence score is low and its overall risk to the patient may be low. However, it is still rated as high risk due to its hi…
Article
Essentials in Establishing and Using Design Space
Variation due to stability may also be included as a noise factor.
Simulation, determination, and visualization of design margin
Using all sources of variation, simulation is used to…
Article
Elucidating Biosimilars Characterization
Characterization of the glycosylation present on recombinant proteins is particularly important as the glycans attached to the molecule can modulate the stability and ability of the molecule to elicit…