Search results for " techniques"
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Managing Biomanufacturing Capacity Expectations
“The customer usually wants to retain its rights to the drug and cell line and how it is made, especially if proprietary techniques are used. The CMO wants the business freedom to use the process tech…
Poster
Process economy effects of modernizations in vaccine purification
Old purification steps are being made obsolete by introducing modern purification techniques, aiming for increased quality and production efficiency, while reducing cost. One technique is core bead ch…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Chromatography techniques are broadly used for detection and isolation of charge and size variants (14). Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS–PAGE) and Western blotting demon…
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
It is a good thing with the development of high throughput techniques and Design of Experiments. Otherwise, the multimodal chromatography approach would have been even more challenging. If we know the…
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
…
Article
SEC in the Modern Downstream Purification Process
Mar 01, 2015
By R. Christopher Manzari, J. Kevin O'Donnell
BioPharm International
Volume 3, Issue 28
Since the introduction of commercial chromatography resins approximately six de…
Article
Challenges of Protein Aggregation During Purification
Use of such real-time process analytical techniques for the monitoring and control of product aggregation will need to be justified, however, with the completion of appropriate cost/benefit analyses,”…
Article
QbD and PAT in Upstream and Downstream Processing
UV control/cutting is the most difficult parameter to control because UV cutting techniques/equipment are still an area for further development. They relatively often challenge batch release (out of s…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
By using modern techniques and cell-based upstream processes it is possible to produce closer to the local market in order to overcome distribution hurdles, as well as to bring down production costs a…