Search results for " control" in Articles / App Notes
Article
Will My Buffers Work When Using an Inline Conditioning System?
Feedback control of the preparation process ensures accurate formulation of the final buffer, and the automation enables high consistency between batches. Compared with traditional buffer preparation,…
Article
Best Practices for Data Integrity
With an electronic system, you get real-time verification of operator data entry, instead of catching mistakes/missed entry in the final quality control review. Operators receive immediate feedback if…
Article
Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
…rectly to the Inline Conditioning system and feedback regulation of the final buffers, using dynamic control, ensured accurate formulations.
Read More in the Application Note
Article
The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
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Article
N-Glycan Analysis of Biotherapeutic Proteins
Future directions in N-glycan analysis
As glycosylation is a frequently monitored CQA of biotherapeutics, there will likely be increasing regulatory pressure to control processes for better …
Article
Fusion Proteins Pose Manufacturability Challenges
“In particular, the level of N-acetylneuraminic acid or sialylation, which can impact plasma half-life and the potency of the candidate, is a key quality attribute and can be challenging to control wi…
Article
Witnessing Major Growth in Next-Generation Antibodies
…ts with novel formats, according to John Joly, senior director of analytical development and quality control with Genentech. He adds that formats have been engineered to engage T cells directly throu…
Article
Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
For complex unit operations such as process chromatography, mechanistic modeling can assist in developing a systematic approach for process development, monitoring, and control. Models can also be jud…