Search results for " start" in Articles / App Notes
Article
Witnessing Major Growth in Next-Generation Antibodies
Problems observed with early CAR T-cell therapies with respect to overly aggressive immune responses have led regulators to require treatments that involve immune responses be started at very low dose…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The European Medicines Agency (EMA) started approving biologics well before the US, and approved 22 biosimilars by the end of 2016.
Unlike a small-molecule drug, however, a biologic drug can’t be …
Article
Reconciling Sensor Communication Gaps
“We need to get past those parameters and start developing sensors that quantify product quality and impurity profiles in a way that is actionable,” Mohindra explains.cleaning validation, and calibrat…
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Evaluating E&L Studies for Single-Use Systems
The reference solutions, before starting the recirculation process, were sampled and tested as well.
CLICK TO VIEW TABLE III
Table III. Extraction study design for option 1, on…
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Drug Quality Key to Innovation and Access
Under the new draft guidance, the program will be voluntary for a year and request three, instead of four, data elements, starting with lot acceptance rate, product quality complaint rate, and invalid…
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Biosimilars to Drive Modern Manufacturing Approaches
“Winning the marathon,” Shapiro continued, starts with analyzing several lots of the reference product over a broad time span. The manufacturer also has to carefully develop analytical methods and the…
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Validation of the production of influenza virus in ReadyToProcess WAVE™ 25 bioreactor system
A 2 L process, developed using the predecessor WAVE Biorector™ 20/50 system, was used as a starting point. Compared with WAVE Biorector™ 20/50, the successor ReadyToProcess WAVE 25 system allows using…
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Defining Risk Assessment of Aseptic Processes
A risk-based approach to determine the source of the microbial increase is a good start. It is important to remember aseptic does not mean sterile and the objective in aseptic processing is to keep th…
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Simplify chromatography method creation
To save time and effort, method creation can be simplified and you can get to the point where you can start the run quicker. Efficient method creation is often about finding useful tips on how to deve…
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Analysis of Glycosylation in Biosimilars
The starting point is those methylated structures, which are acid-cleaved to produce monosaccharides with free hydroxyl groups where the links were split. A reduction step converts the hexoses to line…