Platform technologies—base systems used to make multiple products—are gaining in popularity in biopharma with more and more firms adopting modular manufacturing strategies to bring down costs.
So says Vishnu Kumar, PhD, assistant professor of industrial and systems engineering, Morgan State University in Maryland, who says, “Instead of designing and building a completely new manufacturing process for every drug, companies use a common base ‘platform’ and then plug in different disease-specific components, called modules.
“A good analogy is the automotive industry: many car models are built on the same chassis, with different engines or features added to the platform.”
He adds, “In pharma, mRNA vaccines are a good example. The lipid nanoparticle delivery system is the ‘platform,’ while the mRNA sequence that targets a specific disease is the module. By swapping the mRNA sequence, manufacturers can rapidly create new drugs or vaccines using the same underlying platform.”
Advantages
There is growing industry recognition of the potential benefits of platform technologies, Kumar says, citing increased production speed as an example.
“The same infrastructure can be used to produce multiple products, making it easier to ramp up production quickly. With a pre-established framework, only the disease-specific component needs to be changed, accelerating product development from years to months or even weeks.”
Platform technologies also minimize process validation requirements, Kumar adds.
“Reusing a platform reduces the need for repeated equipment setup or manufacturing steps. For instance, viral vector vaccines can bypass several traditional steps like cell culture and inactivation.
“In addition, integration is smoother because the same platform can be used across multiple facilities and components, even outsourced, allowing modular components to be combined efficiently into the final product,” he says.
Regulatory support
Kumar and co-author Vijay Srinivasan, PhD, from the National Institute of Standards and Technology, looked at platforms in a recent paper, noting that regulatory support is also helping convince drug firms of the potential benefits.
“The U.S. FDA’s Draft Guidance on Platform Technology Designation Program is likely to accelerate adoption of platform approaches. It allows companies to receive regulatory recognition for a well-understood and reproducible platform, which can then be leveraged for multiple products,” Kumar tells GEN.
Applicants receive expedited review for new products. They can also reuse process data, which reduces testing requirements.
The FDA program also offers drug firms the chance of earlier interaction with the agency, according to Kumar, who says, “Overall, this program is expected to make the platform approach more attractive to drug companies, reduce development timelines and costs, and ultimately increase patient access to innovative therapies.”
