Drug development and manufacturing has seen tremendous growth over the last two decades, from highly personalized biologics to the emergence of cell and gene therapies - the industry has seen precision medicine move to the forefront.
Since these newer therapies are designed for specific populations, they don’t always require the traditional large-scale manufacturing operations that our industry is most familiar with. This means drug developers (big and small) and contract development manufacturing organizations (CDMOs) must prepare their businesses for this shift.
This issue is even more prevalent in downstream processing, which remains impacted by serious bottlenecking that can significantly disrupt drug product production.
AGC Biologics CTO, Kasper Møller, recently sat down with our partners at GORE PharmBio for an article with Technology Network to discuss how single-use technologies and optimal downstream processing can address the changing precision medicine dynamic in our industry.
The future of Single-use Technologies
The promise of “disposable” single-use technologies brings a new future for downstream manufacturing processes and efficiencies. Single-use reactors, membranes, and chromatography systems can reduce time spent on lengthy cleaning processes, giving companies and CDMOs more capacity to handle a greater variety of projects. Møller also notes it offers the promising opportunity to handle different drugs at one site.
“You can no longer build a facility that handles just one drug. Your facility must be able to handle more than one drug efficiently, and more and more, we’re seeing single-use technologies enable that."
"Disposable single-use technology is rapidly fueling the innovations we see in manufacturing today. As an example, in upstream processing, we developed and implemented the 6-PackTM scale-out concept, which allows us to inoculate and harvest several main bioreactors from one seed train to establish flexible process scaling.”
Downstream Process Solutions
He also highlights both technical and supplies chain motivations for adopting new technologies and what drug developers are expecting from their CDMO partners today.
CDMOs sometimes struggle to convince clients that these new technologies will work for their products. “Naturally, nobody wants to be the first when it comes to implementing new technology. They want to know how many approved INDs have used that technology,” explained Møller. “However, we have also seen more development and a strong push for implementing new technology and innovation by the FDA over the last ten years. And so clients do expect that new technologies may be incorporated into their workflows. We routinely make agreements with clients to implement specific technology that solves a unique problem for their product.”
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