Search results for " analysis" in Articles / App Notes
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
While many analysis instruments can measure particle size distribution, to identify the nature of particulates in protein therapeutics, information about particle shape and morphology is necessary, sa…
Article
Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
… various methods such as previous experience, literature information, consultants, and knowledge gap analysis. Efforts will be made to close the knowledge gap. This process helps in identifying the c…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
…ors must manipulate by automating sample collection, preparation, method implementation, and results analysis (inline or online), enabling automated and continuous process control—sometimes thought o…
Article
Biosimilar Quality Requirements
Effective Analytical Methods
High-resolution mass spectrometry (HR–MS) is the go-to method for primary structural analysis and characterization of complex protein molecules, particularly following…
Article
Leveraging Data for Better Biopharmaceutical Process Control
…s in upstream processing, with mid- or near-infrared (MIR or NIR) spectroscopies, or some transition analysis and performance studies with ultraviolet (UV) and NIR spectroscopies used in downstream p…
Article
QbD Improves Cell-Culture Process Control
Using a QbD strategy that implements PAT offers the advantage of real-time process monitoring and, subsequently, quality control based on the application of multivariate data analysis and mathematical…
Article
Avoiding Investigational Failures and Discrepancies
An investigation equation has three essential and interdependent components: clarification, decision making, and plan analysis.
Clarification. An investigation should start by thoroughly examin…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
…p-wise method to build an ion-exchange mechanistic model using open-source chromatography design and analysis tool (CADET, https://github.com/modsim/CADET). The mechanistic model used in this approac…
Article
The Metrics of Quality Culture
…nel, the assumption being that the root cause of the original deviation (real or due to insufficient analysis) was determined to be insufficient or ineffectual training. The third proposed metric is …