This Month’s Issue

The BioProcess International November 2015 issue focuses on Manufacturing. The cover features workers setting up a mixer at Bayer Healthcare (

Read it Now.

November Poster Hall Supplement

This special issue provides you with a unique interactive format to view,
experience, listen and discuss how these process technologies and scientific
applications and improve and/or solve your individual process challenges.

Read it Now.



Special Report: Turning Discoveries into Products — Developability Assessments and Highly Efficient Process Design

High costs and long timelines for biopharmaceutical development are cause for reflecting on how best to allocate resources from the earliest discovery stage through critical go–no-go junctures. With inputs ranging from science, engineering, and economics, the coined term developability becomes the synthesis of answers to such questions as How well does the target represent a disease state? Does manipulating that state bring about improvement? Does the molecule behave as expected in living systems? What can be done about the emergence of independent safety, toxicology, and/or immunogenicity warning signs? Can the molecule…

Figure 1: Denaturation of IgG by contact with protein A as shown by X-ray crystallography; modified from (11, 12)

Downstream Processing

The Secret Life of Protein A

Affinity chromatography with protein A has become the foundation for purification of nearly every therapeutic IgG in commercial production. One of the features most responsible for its success has been its compelling simplicity. IgG binds. Contaminants do not. Load, wash, and elute pure IgG. In the real world, however, protein A does not elute pure IgG. It typically contains several hundred to a few thousand parts per million (ppm) contamination by host-cell proteins (HCPs) and other contaminants. Numerous studies demonstrate…

Photo 3:  A student loads a sample into a microchip for analysis by electrophoresis in the  QC/Analytical course.


Comparison of Concentration Measurement Technologies in Bioprocess Solutions

Biopharmaceutical manufacturing involves complex process steps. Exacting production conditions are typically required to maximize the yield, purity, and quality of biological products. In recent years, process analytical technology (PAT) has been increasingly used to monitor key process and performance parameters in real time. That has enabled better control of production conditions. An important parameter required to achieve consistent results in many bioprocessing steps is solute concentration in process fluids. The Critical Need for Concentration Measurement Many biopharmaceutical manufacturing process steps require measuring…