Complexity might be the key word that describes today’s bioprocessing. Philip Vanek, PhD, CTO at Gamma Biosciences in Menlo Park, CA, agrees. He says, “The biggest challenge I see facing the industry—notwithstanding current single-use supply chain challenges—is the increasing complexity of these emerging therapies.”
For advanced therapies—such as ones based on cells, mRNA, or viruses—Vanek points out that one challenge is “their molecular and structural complexity, often linked hand in hand with the size of the therapeutic molecule.” He adds that “size, complexity, and the requirement for sterility throughout the process has increased the demand for single-use technologies, automation, and scalable production platforms that—when combined—reduce risk and ultimately the cost of manufacturing.”
That poses a collection of challenges for a bioprocessor to address. There are various ways to specifically approach those obstacles, but Vanek and his colleagues take a more general strategy.
“We believe that a systems-level perspective is necessary to solve the challenges faced by the advanced-therapy industry,” Vanek explains. “We look beyond the unit operations of a manufacturing workflow, to understand the interconnectedness and knock-on effects of changes in any one step, and how those changes impact operations within the boundaries of a risk-focused regulated manufacturing environment.”
Taking a systems-level approach, Vanek says, requires a “deep process-level understanding.” With that, he adds, “we look for disruptive technologies that—when collectively enabled—add up to more than the sum of the parts.” To put together such disruptive tools, Vanek and his colleagues “invest in these technologies to accelerate their development and market adoption.”
As a result, he believes they “are playing a small but significant part in accelerating the availability of next-generation medicines for the patients so desperately awaiting them.”