Search results for " techniques"
Article
Handbook: Size Exclusion Chromatography Principles and Methods
This handbook describes the use of SEC for the purification and separation of biomolecules, with a focus on practical information for obtaining the best results. The media available, selection crite…
Article
Securing the Single-Use Supply Chain
“These results indicated that the materials were comparable within the variability of the analytical techniques used,” Briggs says. He also recognizes that tubing is a universal single-use component, …
Article
High-Throughput Process Development in an Historical Environment
As an example, John Welsh from Merck presented a collaboration with Cytiva on the development of the next- generation multimodal chromatography resins and how high throughput techniques and different …
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
Cross flow filtration (CFF) is a technique extensively used in vaccine production and particularly in influenza vaccine manufacturing. In contrast to normal flow (dead-end) filtration (NFF), the fee…
Article
Applying GMPs to the BioPharma Supply Chain
Capabilities will need to be developed and tools and techniques learned. The drivers for change are powerful and unrelenting, but biopharmaceutical companies are ready for the challenge.
At some p…
Article
Challenges in Analytical Method Development and Validation
…are, critical reagents, standards, controls, and analysts who are skilled in the relevant analytical techniques as well as the qualification status of all materials, equipment, and analysts.
If g…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Different statistical techniques may be employed commensurate with the risk of the parameter or attribute being analyzed and the frequency of its analysis. More complicated tools such as charts of cum…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
IEC 60812, Analysis Techniques for System Reliability-Procedure for Failure Mode and Effects Analysis (FMEA), Edition 2.0 (January 2006).
8. ISPE, Product Quality Lifecycle Initiative (PQLI) Good …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…