Search results for "purification" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Otherwise, cell culture, purification, and drug product development may put undue importance on meeting certain criteria that are ultimately not critical, resulting in suboptimal processes that make u…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
When SEC alone is suitable
In certain purification or formulation tasks, it may suffice to determine only the fraction of aggregated protein relative to the unaggregated monomer, rather than the t…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The authors would also like to thank Amanda Bell, Wenkui Lan, and Ya Fu for their support in protein purification and protein quality analysis.
References
1. B. Kelley, mAbs. 1 (5) 443-452 (20…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
Chromatography is the last purification unit operation to move to disposability and has seen only limited use, according to Gebski. She notes that the adoption of pre-packed, limited-use chromatograph…
Article
Q&As with Industry Leaders
…duct Manager, Monoclonal Antibody Polishing, Cytiva
Top challenges in recombinant protein purification process development
Jeanne Linke Northrop, BioPharm International
Emma Li…
Article
Raw Material Variability
Many of these issues would be upstream in the cell-culture or fermentation step but could also be downstream in purification. The ‘blackbox’ nature of upstream processes makes things doubly difficult.…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
For example, to perform a multivariate study on a fermentation unit operation, additional processing through cell lysis and purification unit operations is needed so that CQAs may be sampled and teste…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The conclusion was that the prion reduction capacity of existing steps in the manufacturing purification processes should be considered as a major risk reduction factor with respect to the safety of p…
Article
Regulatory Challenges in the QbD Paradigm
…ive hold times, if needed, or limited hold steps where appropriate
• Lifetime use studies for purification media (i.e., resins and membranes)
• Validation and verification of cleaning process…