Search results for " specification" in Articles / App Notes
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar
Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…
Article
Reconciling Sensor Communication Gaps
Platforming, whether it occurs upstream or downstream, relies on controls to maintain operations within specification. Yet the imperative to improve process understanding—even for exquisitely controll…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Process Chromatography Selection for Downstream Processing Applications
It is important to consider these buffer specifications at large scale may be +/- 1 mS/cm and +/- 0.1 pH unit. Thus, during process development it is important to ensure the process is robust within t…
Article
Affinity Chromatography Handbook in 3 Volumes
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
Article
Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
By Eric S. Langer
Downstream processing continues to be a significant pain poi…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
ICH, Q6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Step 4 version (1999).
9. S.L. Davies et al., Biotechnol. Bioeng. 110 (1), pp. 260–274 (2…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
Article
Going Small to Achieve Success on the Commercial Scale
The development of commercial-scale processes that consistently provide high-quality product that meets those specifications requires extensive examination of numerous process variables and potential …