Process Development Manufacturing: Biotherapeutics
The huge potential of biotherapeutics for revolutionizing healthcare is, unfortunately, matched by equally enormous challenges inherent in commercializing them. Upstream challenges with proof of concept, for example. Or downstream challenges such as process development for experiments, qualification methods and QC/QA strategies.
And all these challenges can pale in comparison to the work involved with successfully meeting rigorous requirements for cGMP manufacturing—while at the same time minimizing risks and costs every step of the way.
Biopharma companies can’t manufacture anything until they complete their process development work. And in today’s hyper-competitive marketplace, pressure to expedite process development for biotherapies is relentless.
But if slow progress “from molecule to market” were a disease afflicting today’s biomanufacturers, one element of an effective treatment plan would be identifying expert partners who can provide the insights and technologies needed to efficiently accelerate the complex process from beginning to end.
Isolating and purifying exosomes remains challenging, but evolving techniques—such as flow cytometry or combining high-speed and density gradient ultracentrifugation—might be key to addressing some of those challenges.
Numerous viral vectors are now being used to develop promising new gene therapies, and assessing the purity/safety of these vectors demands high-resolution, quantitative and in-solution analytical techniques.
High-grade purification of a new pharmaceutical protein of interest (painstakingly isolated from among thousands of others) begins with time-tested techniques such as differential and/or rate-zonal centrifugation.