Author Archive

What we are seeing as we work with customers is a drive to simplify and compress processes as much as possible.   Perhaps five years ago, there was a protein A column, low pH step, cation exchange (CEX), anion exchange and a virus filtration step.   What we see now is customers who don’t include, or ...

Historically, development of protein therapeutics relied on a customized approach for each new molecule. Early efforts focused on establishment of a fixed process that delivered the required quality. Unfortunately, this approach limited application of continuous improvement and incorporation of new technologies to enable improvements in safety and efficacy. In an effort to address this, platform technologies, ...

The concept of platform technologies started in the industry with the belief that one could purify all monoclonal antibodies the same sequence of technologies: Protein A, cation exchange and then anion exchange. While this is true, what remains to be defined for each new molecule are the specific parameters for each unit, type of ...

We are using platform technologies mainly for the purification of recombinant antibodies from mammalian cell culture. In developing the initial platform, we conducted a research project. Up to now we evaluated several different antibodies from CHO or hybridoma cell cultures. The biggest difference we saw was besides the characteristics of the different subclasses, ...

Historically, development of protein therapeutics relied on a customized approach for each new molecule. Early efforts focused on establishment of a fixed process that delivered the required quality. Unfortunately, this approach limited application of continuous improvement and incorporation of new technologies to enable improvements in safety and efficacy. In an effort to address this, platform technologies, in which prior ...

Increased efficiency from upstream production is putting increasing pressure on downstream unit operations. Higher overall output of biomanufacturing processes cannot be achieved until the downstream purification processes can keep up. The batch nature of traditional, labor-intensive column-based systems can create a significant bottleneck. Continuous chromatography shows promise in the lab and at pilot-scale. Is continuous chromatography the ...