Search results for " separation" in Articles / App Notes
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
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
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
A gradient separation was performed using mobile phase A: 50 mM phosphate, 4 mM 1-heptanesulfonic acid, pH 4.5 and mobile phase B: 30% acetonitrile and 10% methanol in mobile phase A (other method det…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
That may partly be due to the current bottlenecks being experienced in purification and separation operations. And CMOs’ experience with multiple products and campaigns provide them expertise that in-…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…
Article
Handbook: Size Exclusion Chromatography Principles and Methods
The first step towards a successful separation is to select the correct medium and this handbook focuses on the most up-to-date SEC media and prepacked columns.
Download now.
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Scores are based upon three values, as shown in Figure 4 (1=green, 3=yellow, 9=red) to obtain separation and clearly identify criticality. The result of the analysis for each unit operation is a list …