DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

  The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

• Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance

  Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

• Biomanufacturing Flexibility

  This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.

• Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography

  The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.

• Examining Column Reproducibility During Method Development In Clinical Labs

  In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

• Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

  Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.