Search results for " variability" in Articles / App Notes
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Figure 1: Graphic showing IgG antibody structure, sites for glycosylation, and potential variability.
Proteins are delicate molecules compared with small-molecule drugs and present multiple stabili…
Article
Best Practices in Qualification of Single-Use Systems
The alignment of criteria should include any variability in appearance, such as minor blemishes on the exterior of SUS arising from transport and handling, which do not impair the function of the asse…
Article
Robust Optimization, Simulation, and Effective Design Space
…s could follow a sequence such as the one shown below:
• Identify potential sources of process variability.
• Identify the material attributes and process parameters likely to have the greate…
Article
DoE Provides Benefits, but Preparation Is Necessary
“While a formulation scientist needs to know where the most stable space for an API resides, an analytical chemist may be more interested in the variability and reproducibility of results, both of whi…
Article
Applying GMPs to the BioPharma Supply Chain
Elimination and control of sources of variation
Suppliers need to understand how variability in the manufacturing process affects the quality attributes of their product. They need to have tools t…
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
Advancing QbD in the EU
"These biological principles may display inherent variability," the new annex states. "As a result, QRM principles are particularly important for this class of materials." The annex includes a new sec…
Article
Evaluating the Use of Continuous Chromatography
…aphy contributes to increased consistency of product quality as well as better management of process variability. In addition, control of the downstream processing steps can lead to cost reductions (…
Article
A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
Article
Moving Biosimilars Forward in a Hesitant Market
Dealing with challenges
Other hurdles to bringing a biosimilar to market include the availability of the reference biologic and the batch-to-batch variability of that reference product; this is on t…