Technology that was developed to produce energy-dense rocket fuel has been adapted to produce protein-dense therapeutic formulations. Such formulations are expected to reach new heights, escaping the clinic-centered world of intravenous infusions and exploring new worlds in which large-molecule therapeutics can be delivered via subcutaneous injection. These new worlds include the homes of patients. Imagine seeing patients self-administer large-molecule medications and escaping the surly bonds of the infusion clinic.

The technology to realize this vision comes from Elektrofi, a formulation company that is partnering with drug developers to help them hyperconcentrate their therapeutics. Appropriately enough, Elektrofi’s technology is called Hypercon. “We don’t discover therapeutic compounds,” says Chase Coffman, PhD, Elektrofi’s CEO. “We repackage them so they can be much easier for patients to take advantage of.”

Density and fluidity

Hypercon is suitable for a wide range of proteins, including difficult-to-formulate molecules. For biopharmaceutical manufacturers, this helps extend patent life, enhances product differentiation in competitive indications, and keeps formulations stable at room temperature for up to three years.

“Essentially, we take a drug substance (typically in liquid form) and convert it through a series of proprietary methodologies into an ensemble of very smooth and spherical microparticles,” Coffman explains. “Then we disperse those particles into an oily carrier medium that is eminently flowable and syringable, even at extremely high concentrations that are not otherwise accessible through conventional approaches to drug product formulation.”

Throughout the process, the protein molecule’s quality, shape, and size are preserved, and the concentration of injectable microparticle suspensions can exceed 600 mg/mL. In many cases, the concentration can be as much as five times that of standard formulations. Not only are Hypercon formulations capable of eliminating the need for infusions, they are also capable of reducing the frequency of injections by as much as half thanks to the concentrated dosages.

Inspiration from rocket science

About 10 years ago, as a student at Massachusetts Institute of Technology, Coffman was helping to develop a microelectric rocket for “CubeSats,” ultrasmall satellites that are used to test new space technologies.

“One term, a couple of us were sitting in an entrepreneurship class looking at commercialization opportunities associated with the technology,” Coffman recalls. “Based on the feedback from our instructor, we started looking at alternative applications. We discovered the propulsion system had all sorts of interesting terrestrial applications.”

With that realization, the classmates focused on the intersection of protein processing and microparticle manufacturing. To explore this space, they used a version of a component of the propulsion technology they had developed.

One of the attractions, Coffman says, is that “the life sciences industry, unlike many other industries, maintains a firm, tangible linkage between innovation and impact at the human level. That linkage really resonated with us because, in part, as a satellite engineer, I had always struggled to explain to my family and friends how the work I was doing in the laboratory would benefit humans on the ground.”

That tangible linkage gave Coffman and his co-founders the confidence they needed to become life sciences entrepreneurs dedicated to improving patients’ experiences. He says that in the beginning they wore the rosiest of rose-colored glasses. “We soon got a nice, sobering dose of reality,” he admits. “Things took a little longer than anticipated, and they cost a bit more money.”

Eventually, Coffery came to appreciate that virtually all startup entrepreneurs overlook potential pitfalls. “In a lot of ways, I think this tendency can be good for startup entrepreneurs,” he says.“If they had a more accurate view of reality, they might not launch new ventures.”

No free lunch

“There’s a price to be paid for these ultrahigh concentrations,” Coffman acknowledges. “There is no free lunch.” The price Coffman refers to is the need to deal with additional chemistry, manufacturing, and control concerns. For example, producing hyperconcentrated formulations requires specialized equipment.

Coffman points out that Elektrofi has developed a “unique equipment train” to manufacture microparticles that can be used to produce ultrahigh-concentration formulations. “We’re working to implement this now, alongside our strategic partner, Thermo Fisher Scientific,” he continues. “There are some extra expenses to be incurred for manufacturing. But for the right partners and products, that’s a small price to pay in exchange for really opening the door for patients.”

For companies interested in partnering with Elektrofi, the process is straightforward. “In most cases, Elektrofi does most of the preclinical work in terms of developing a custom, high-concentration formulation,” Coffman says. It also may lend insight into nonclinical studies that are required before human trials begin. Then, the partner company takes over to launch clinical trials and meet any regulatory requirements.

The protein microparticles in this scanning electron micrograph were created using Elektrofi’s Hypercon formulation technology. Gentle dehydration results in smooth, spherical microparticles that dissolve into fully functional protein monomers in the subcutaneous space. The image width corresponds to about 200 μm.

Programs and partners

Elektrofi is working with pharma and biopharma companies on protein therapeutics that already are commercialized or that are in clinical development. Current programs include those in autoimmune and other immunological disorders, oncology, and neurology, but the company is open to working with drug developers in a variety of therapeutic areas.

In January, Elektrofi announced a major partnership with Janssen Biotech, a Johnson & Johnson company, on the heels of a similar partnership with Eli Lilly and Company. Earlier, Elektrofi secured an agreement with the Belgian company, Argenx, to develop antibody products. “We’re really excited about what that augers for our future,” Coffman says.

True to a vision

When the company was formed in 2016, it was bootstrapped with funds from friends and family. “We were fortunate to have a lot of individuals close to us who were willing to take the proverbial leap of faith,” Coffman remembers. “For that, we’re grateful.” 

Government support has helped, too. “The National Science Foundation, in particular, has been a big supporter,” he says. Then, in 2022, Elektrofi raised $40 million, marking the first time institutional investors participated. That funding helped lay the groundwork for clinical and good manufacturing practice (GMP) readiness. “We are participating in several human clinical trials that are scheduled to start in mid-2025,” Coffman reports. “To do that, we need to begin manufacturing GMP materials this year.” Next year, the challenge will be achieving positive human clinical readouts.

The company has expanded to nearly 70 employees. “But we’re very much on the same path we charted in the early days, which is no small feat,” Coffman insists. Elektrofi’s founding goal was to maximize the positive impact on patients. “This is still our guiding philosophy,” Coffman declares. “We want to map this technology out as broadly as possible with partnerships across the therapeutic landscape.”   

Previous articleBioplastic “Alive” with Bacterial Spores Can Compost Itself
Next articleCell Therapy Manufacturing: Time to Move Fast