This Month’s Issue

The BioProcess International April 2016 production theme issue cover is illustrated by TAP Biosystems microscale bioreactors from Sartorius Stedim Biotech. (

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Building the Bridge to Commercial Success

For the cell and gene therapy business, learning from the failures and successes of the protein-based markets’ journey to commercial success provides a treasure-trove of knowledge and experience that can and should be followed in order to use and reproduce what worked, while steering clear of what didn’t. One clear lesson is clear: in order for the cell and gene therapy industry to complete the bridge to commercial success, technology must catch up to the science.

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Figure 1: Host-cell protein and leached protein A analytical technologies

High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development

Getting biologic drugs through development and into clinical proof-of-concept studies quickly and efficiently is critical for success in the biopharmaceutical industry. Implementing high-throughput approaches to both upstream and downstream process development is increasingly helping companies stay competitive. Innovative and highthroughput analytical technologies are needed to support rapid process development. The study reported herein focuses on innovative immunoassay platforms for impurity-removal monitoring of both host-cell proteins (HCPs) and leached protein A. HCPs come from host cells during cell culture production. Their…

Table 1: Substrate specificity of commercially available endoglycosidases (      sialic acid,         galactose,      mannose,      GlcNAc,       fucose)


Using Glycosidases to Remove, Trim, or Modify Glycans on Therapeutic Proteins

One of the most common posttranslational modifications of eukaryotic proteins is glycosylation. Glycosylation of proteins can affect many biological activities. For therapeutic glycoproteins, it can modify biological activity, targeting, trafficking, serum half life, clearance, and recognition by receptors (1, 2). For such reasons, biomanufacturers must monitor and characterize the glycosylation patterns of their recombinant therapeutic proteins (3, 4). Therapeutic proteins have two main types of glycosylation: N-linked glycans and O-linked glycans (5). Attachment of an N-glycan starts in the endoplasmic…

Figure 1: The NGC Discover 10 Pro system with an additional column switching valve illustrates the connectivity between modules used: components are 1 = buffer blending valve, 2 = buffer inlet valves, 3 = system pumps, 4 = sample inlet valve, 5 = sample pump, 6 = sample injection valve,  7 = column switching valves, 8 = multiwavelength detector with integrated conductivity monitor,  9 = pH module, 10 = outlet valve, 11 = BioFrac fraction collector.

Downstream Processing

Automated Purification of Native and Recombinant Proteins Using Multidimensional Chromatography

In traditional sequential chromatography, columns are run as separate entities. The process requires significant hands-on time and constant manual intervention. By contrast, automated chromatography technology provides the same results more efficiently and reliably and frees researchers to focus on other tasks, thereby shortening protein purification times from days to hours. For drug discovery, purifying protein samples is required to generate enough materials for research experiments. But the process is complex and time consuming. It involves repeated single-column purifications, careful analysis,…