Continuous manufacturing has already started to supplant traditional batch processing in the realm of tablet production. The next area due for a manufacturing overhaul? Nanoparticle drug delivery systems, one startup thinks—and it's now primed to pitch its platform to drugmakers.
The University of Connecticut recently licensed its continuous nanoparticle manufacturing technology to DIANT Pharma, a startup co-founded by the platform's developers Antonio Costa, Ph.D., and Diane Burgess, Ph.D.
The high-throughput system has the potential to save clean room space, lower the number of processing steps and reduce the number of batches produced per year. Because the platform is continuous, it should enable manufacturers to jump in if anything goes wrong, diverting or removing only a small portion of the product rather than scrapping an entire batch, Costa, CEO at DIANT and assistant research professor at UConn, said in an interview.
The manufacturing tech was originally designed with an emphasis on liposomal formulations, the university said in a release. In its current form, the modular technology can be used to create a variety of complex drug and drug delivery products, from liposomes and lipid nanoparticles to polymeric micelles and emulsions, Costa said.
That initial laser focus on liposomes was inspired by one of the grizzlier drug manufacturing imbroglios in recent years, Costa explained: Back in 2011, manufacturing and sterility problems at the Boehringer Ingelheim unit Ben Venue Laboratories halted production of Johnson & Johnson's ovarian cancer drug Doxil, or liposomal doxorubicin.
There were no alternatives for a much-needed drug, Costa said—that is, until India's Sun Pharma swooped in with a generic solution. But not all generic drugs are the same, and there's been much evidence to suggest there are major differences between generic and brand-name nanomedicines in terms of particle size, distribution and morphology, Costa said.
That lack of uniformity can in turn lead to different side effects, efficacy and formulation stability of the final product, he added.
This inspired Costa and Burgess, whose team started work on the continuous manufacturing technology in 2013, to choose liposomal doxorubicin as a model formulation for their platform.
DIANT's technology leverages a turbulent jet mixing technique, coupled with an advanced particle size analysis system and feedback loops, to form highly monodispersed, or uniform, nanoparticles—potentially reducing some of the uncertainties that come with poorly controlled particle size.
Meanwhile, the fact that the system is modular means that if a plant making liposomal nanoparticles were to go down—not outside the realm of possibility given the nanoparticles' complexity—manufacturers could quickly pick up the work at another site leveraging DIANT's platform.
DIANT so far has already sold one of its GMP-ready commercial manufacturing systems, Costa said. The entire clean room footprint for the system is around 2,000 square feet—more spatially economical than the roughly 10,000 square feet needed for typical batch manufacturing.
The company has snared exclusive license to commercialize the product from UConn and is now seeking additional partners, especially in the lipid nanoparticle space.
It could be a crucial field for continuous manufacturing, especially given the positive results coming from Pfizer and Moderna's COVID-19 vaccine candidates, both of which leverage mRNA lipid nanoparticles.
If those companies are successful with their shots, it will pave the way not only for more vaccines that utilize the tech but potentially for cancer treatments, too, Costa figures.
That would in turn make DIANT's system all the more valuable, and, with the perks of continuous manufacturing already established in other fields, the company's platform is poised to help usher in a new era in the injectable nanoparticle manufacturing space.