This Month’s Issue
The BioProcess International June 2016 manufacturing theme issue cover is illustrated by a quality assurance technician at AstraZeneca’s facility in Maccleston, UK (www.astrazeneca.com)
In June 2016, Pall Life Sciences published a special supplement driven by their desire to share actionable knowledge to act as a guidepost for the evolution of continuous processing. The goal of this project is to encourage a deeper discussion about continuous bioprocessing technology and the dramatic impact it can have – and is already having on the biopharmaceutical industry.
Biophysical characterization has drawn great attention from the biopharmaceutical industry and regulatory agencies across the globe, especially for use in biosimilar drug product development. Currently available biophysical characterization tools can help in screening and optimizing better (more stable) formulations for such products. However, most tools cannot be used for head-to-head comparison of the biophysical properties of an optimized biosimilar formulation with those of an innovator product at higher concentrations. We developed and optimized a formulation for monoclonal antibody MAb B…