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)

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Is Continuous Bioprocessing the Future?

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.

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Analytical

The Zetasizer Helix system combines Raman spectroscopy with dynamic light scattering.  MALVERN INSTRUMENTS (WWW.MALVERN.COM)

Enhanced Biosimilar Product Characterization: A Case Study Using Raman Spectroscopy Combined with Dynamic Light Scattering

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…

Figure 1: The quality by design (QbD) approach aligns with product and process development stages and clinical development phases. QbD provides milestones and assessments to facilitate product development and ensure quality. (BLA = biologics license application)

Analytical

Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development

The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…

P. GINTER, SARTORIUS STEDIM BIOTECH (WWW.SARTORIUS.COM)

Manufacturing

Bridging Polymer Science and Biotechnology Applications with Single-Use Technologies

Implementation of single-use technology in the biotechnology industry is increasing every year. One major interest has been understanding the interaction of extractables with protein and cells for applications ranging from cell banking to biopharmaceutical manufacturing. In October 2015, the Engineering Conference International (ECI) organization hosted a conference in Leesburg, VA, to explore how the science of plastic applies to bioprocessing. The “Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications” meeting brought together experts from different fields to share issues, understanding,…