Search results for " process characterization"
Article
Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system.
Stay up-to-date wit…
Article
Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Overall, the design space developed from process characterization study models represents a level of process understanding. Like all models, however, the design space is only as good as the data that …
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Understanding Validation and Technical Transfer, Part 3
Process and analytical development includes validation master planning, process characterization, and process parameter criticality assessment and classification. During the implementation and commerc…
Article
Being Thorough When Transferring Technology
This becomes invaluable to others later, and helps support claims for process characterization and robustness; selection of control and critical parameters; and setting of specifications. A summary of…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Prior to process characterization experiments, this risk assessment may be more high level using primarily prior knowledge and scientific principles. However, a more formal FEMCA may also be considere…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Mapping a Route for Cell and Gene Therapy Process Development
… high-quality materials generated by qualified vendors are not available
- A lack of adequate process characterization tools and technologies.
Many of these challenges apply to the deve…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…