Featured Content

The latest issue of BioProcess International focuses on bioprocessing analytical methods including particle contaminant identification, host cell protein detection, cell culture process development, and articles on using QbD for monoclonal antibody processes, cost modeling for bioproduction, the role of Big Data in biopharmaceutical R&D, and the Bioprocess Insights Special Report.

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Contract Services Supplement

Key topics in this issue are capacity predictions, the challenge of preparing products for multiple regions, the influence of advanced and emerging therapies on service offerings, the incorporation of new platforms and analytical methods, and the continuing exploration of disposable technologies (and how they, among other tools, are advancing progress toward continuous operations).

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Analytical

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Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control

State-of-the-art analytics guide process development by providing companies with thorough understanding, effective removal, suitable control, and comparability assessment after process changes of host cell proteins (HCPs) in recombinant biotechnology products. An array of analytical techniques and approaches can be used to establish control strategies for host cell proteins. Techniques used for HCP characterization and comparability include two-dimensional (2D) gel electrophoresis with a range of stains, 2D immunoblotting, 2D high-performance liquid chromatography (HPLC), 2D difference gel electrophoresis (DIGE), and increasingly mass…

determined by Jiang et al. for a hydrophobic-interaction chromatography (HIC) step used to purify an Fc fusion protein (4). This example shows the acceptable design space for protein loading and HIC resin hydrophobicity (defined in minutes of lysozyme retention time) related to high–molecular-weight content (a CQA for the product) and step yield (an important process performance attribute)

Analytical

Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and Control Strategies

Process design space and control strategy are two fundamental elements of quality by design (QbD) that must be established as part of biopharmaceutical development and regulatory filings. Like all of QbD, they are interconnected and iterative. Both are based on knowledge gained during product and process development — but both need to be in place (in a potentially very limited form) when a company begins to manufacture drug substance for clinical trials. Part 1 of this discussion appears on pages…

Figure 1: Absorbance Fourier-transform infrared (FT-IR) spectra of different test articles made of polypropylene

Analytical

Investigation of Foreign-Particle Contamination: Practical Application of FT-IR, Raman, and SEM-EDS Technologies

The presence of visible foreign particulate matter is considered a critical defect in parenteral products and one of the main reasons they can be recalled (1). Foreign particles present during any stage of manufacturing are considered to be contaminants and can impose a risk to the control of the manufacturing processes (2). For those reasons, particle contamination arising in any manufacturing step initiates a nonconformance or out-of-specification observation. That requires an investigation to identify root cause so as to mitigate…