Search results for " design-of-experiments"

Article Optimization of an antibody polishing step
Antibody purification processes are typically developed using a platform approach. Optimal operating conditions for single units are found by altering just a few process parameters with De…

Article Accelerating VLP purification process development
See how using mechanistic modeling can speed up the purification process development of virus-like particles (VLPs). Indeed, a method for the large-scale production of VLPs is produ…

Article Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.  By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari  Recombinant protein products have…

Article Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs. By Cynthia A. Challener Bioreactor design, including the geometry of the tank and impeller and the locati…

Article Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes. By Cynthia A. Challener Biopharmaceutical manufacturing involves a series o…

Article Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis. By Michiel E. Ultee, PhD, Dr. Richard Easton This article reviews the implications of cell-culture co…

Article Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions. Dec 01, 2014 By Cynthia Challener, PhD BioPharm International A key component of the quality-by-design (QbD) ap…

Article DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 11, Issue 27, pp. 28-29  Using a design-of-experiment (DoE) approach allows a formulation development scientist t…

Article Using Quality by Design to Develop Robust Chromatographic Methods
Two separate design-of-experiments (DoE) studies were performed to identify and verify the optimum method conditions. The first DoE was conducted to explore and identify a preliminary set of chromatog…

Article A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…

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