“The best way to make things efficient and repeatable is to make them less complex.”
That’s the opinion of Josh Ludwig, global commercial director at ScaleReady, and the guiding principle of lean manufacturing. For biopharma entrepreneurs, it’s never too early to take that message to heart. Not planning with manufacturing in mind—even during early development—is a key reason fledgling biopharma companies fail.
Admittedly, nascent companies are constrained by funding, space, and technical decisions made years ago by their institutes. “Researchers cobble together things…in ways no one would use for commercial manufacturing because they’re too complex or too hands-on,” he says, and that accelerates cash burn.
His advice?
First, understand that not every process measurement adds value during manufacturing. Make copious measurements during development, but “when you move into manufacturing, be judicious in terms of what you’re measuring, and its cost-to-reward ratio. Only measure and monitor what’s beneficial.”
Second, realize that not every process is unique. Standardizing processes establishes a path toward trial-sized quantities and commercialization potential investors view favorably. Unless a biopharma product’s process can scale to thousands or tens of thousands of runs per year, investors will discount it, Ludwig explains.
For the cell and gene institutes that often are the out-licensing middleman between principal investigators (PIs) and larger biopharma companies, ensuring process standardization is particularly important.
“Are there ways you could set up yourself—and whoever licenses the technology—for success?” Ludwig asks. “We say ‘yes,’ but you have to think about that early, and it has to be the through line of your institute or your company.” It helps, he says, to “bring in folks who really know manufacturing…and who have experience with lean manufacturing.”
Specifically, Ludwig urges institutes’ process development and manufacturing groups to co-develop standard industrial processes PIs can use for cell and gene therapy scale-up. This contains costs by using the same basic procedures and equipment for multiple projects and, because they were developed with manufacturing in mind, derisks the scaleup path for potential investors, thus enhancing value.
For both investigators and institutes, he says, “Choose tools, technology, and equipment with simplified designs so they are easy to use, that have distinct unit operations so they can process multiple batches simultaneously, and that can scale down as well as up. Make sure it’s cost-effective for making small, starting cell quantities all the way up to full doses.”
Thinking early about these issues helps institutes and young companies eliminate unneeded complexity as they scale and, therefore, conserve cash, and better position their products for licensing or acquisition.
The post Make Bioprocesses More Efficient by Making Them Less Complex appeared first on GEN - Genetic Engineering and Biotechnology News.
That’s the opinion of Josh Ludwig, global commercial director at ScaleReady, and the guiding principle of lean manufacturing. For biopharma entrepreneurs, it’s never too early to take that message to heart. Not planning with manufacturing in mind—even during early development—is a key reason fledgling biopharma companies fail.
Admittedly, nascent companies are constrained by funding, space, and technical decisions made years ago by their institutes. “Researchers cobble together things…in ways no one would use for commercial manufacturing because they’re too complex or too hands-on,” he says, and that accelerates cash burn.
His advice?
First, understand that not every process measurement adds value during manufacturing. Make copious measurements during development, but “when you move into manufacturing, be judicious in terms of what you’re measuring, and its cost-to-reward ratio. Only measure and monitor what’s beneficial.”
Second, realize that not every process is unique. Standardizing processes establishes a path toward trial-sized quantities and commercialization potential investors view favorably. Unless a biopharma product’s process can scale to thousands or tens of thousands of runs per year, investors will discount it, Ludwig explains.
Use standard processes
For the cell and gene institutes that often are the out-licensing middleman between principal investigators (PIs) and larger biopharma companies, ensuring process standardization is particularly important.
“Are there ways you could set up yourself—and whoever licenses the technology—for success?” Ludwig asks. “We say ‘yes,’ but you have to think about that early, and it has to be the through line of your institute or your company.” It helps, he says, to “bring in folks who really know manufacturing…and who have experience with lean manufacturing.”
Specifically, Ludwig urges institutes’ process development and manufacturing groups to co-develop standard industrial processes PIs can use for cell and gene therapy scale-up. This contains costs by using the same basic procedures and equipment for multiple projects and, because they were developed with manufacturing in mind, derisks the scaleup path for potential investors, thus enhancing value.
For both investigators and institutes, he says, “Choose tools, technology, and equipment with simplified designs so they are easy to use, that have distinct unit operations so they can process multiple batches simultaneously, and that can scale down as well as up. Make sure it’s cost-effective for making small, starting cell quantities all the way up to full doses.”
Thinking early about these issues helps institutes and young companies eliminate unneeded complexity as they scale and, therefore, conserve cash, and better position their products for licensing or acquisition.
The post Make Bioprocesses More Efficient by Making Them Less Complex appeared first on GEN - Genetic Engineering and Biotechnology News.