Author Archives: Katy McLaughlin

Rethinking Chromatography

Dynamic trends in the biotherapeutic industry are shifting manufacturers towards new modalities and intensified production strategies. This development is supported by ongoing scientific and technical advances in both upstream and downstream processing steps. Downstream processing of new modalities requires chromatography technologies that can handle large, fragile molecules (such as mRNA and viral particles). To maximize speed and productivity, platforms supporting continuous processing will become essential. In this feature, Sartorius discusses current and future concerns for process chromatography operations. They then…

Finding the Right Partner for Outsourced Cell-Line Development

The successful commercialization of a biopharmaceutical product begins with a robust and productive cell line. Inefficient cell-line development (CLD) can lead to costly delays and roadblocks. For that reason, small, new, and virtual companies — and even established and mid-size companies — often seek the support of outsourcing partners to develop their cell lines. Outsourcing CLD activities can ease many pressures associated with manufacturing new biotherapeutics. The benefits of outsourcing CLD and associated processes include access to specialized expertise and…

A Strategic Approach to Selecting the Optimal Process Intensification Scenario

Current demands placed on the biopharmaceutical industry are pushing manufacturers toward process intensification, an approach that modifies unit operations or an entire manufacturing process to optimize efficiency. Three common intensification scenarios in upstream processing are seed-train intensification (usually at the n – 1 stage), concentrated fed-batch production, and dynamic perfusion (at the production bioreactor stage). In downstream processes, intensification strategies typically involve moving from single- to multicolumn chromatography. Biomanufacturers can realize several kinds of improvements from intensified processing, including reductions…