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News|Videos|October 29, 2026

18-Month Room-Temperature Data Support Hyaluronidase-Free Antibody Suspensions, Says Nanoform’s Chris Worrall

In the second part of an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 414 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.

Ultra-high-concentration antibody suspensions may do more than push past formulation limits. They could also change how and where biologics are stored and administered. Continuing his interview with BioPharm International® as part of its AAPS PharmSci 360 2026 coverage, Chris Worrall, PhD, vice president of US business development at Nanoform, discusses new stability data for the company’s trastuzumab suspension, plans to move into the clinic, and what the approach could mean for patients.

“Potentially these formulations could also alleviate some of the requirement for cold chain storage.” – Chris Worrall, PhD, vice president of US business development, Nanoform

In the first part of the interview, Worrall explains why stability and viscosity have kept antibody formulations below 200 mg/mL and how Nanoform’s low-temperature particle engineering process and non-aqueous suspensions are designed to get past that limit.

At AAPS PharmSci 360, Worrall presented 12-month stability data, and he says the company now has 18-month data. In suspension, a 414 mg/mL trastuzumab formulation, roughly four times the concentration of the currently marketed product, showed less than a 1% increase in high-molecular-weight content after 18 months at room temperature. Worrall reports no significant sedimentation and a stable injection force below 15 newtons through a 27-gauge needle at 1 mL per minute.

That room-temperature stability contrasts with the current subcutaneous formulation, Herceptin Hylecta, which must be stored refrigerated at 2 °C to 8 °C and, according to its prescribing information, administered within four hours of removal from the refrigerator. “We’ve been able to show that we have 18-month stability data even at room temperature,” Worrall says.

How could ultra-high-concentration suspensions change antibody administration?

Herceptin Hylecta relies on hyaluronidase to enable its larger injection volume, while Nanoform’s suspension does not require it. Worrall notes that the suspension is able to match the exposure of the solution formulation. In a minipig study reported by Nanoform in February 2026, the company said the pharmacokinetics of its hyaluronidase-free suspension closely mirrored Herceptin Hylecta. Worrall adds that clients have shown in higher animals, including nonhuman primates, that suspensions are “at least as good as the solutions.”

The next step is to produce GMP material and enter the clinic, and Worrall says Nanoform anticipates producing clinical material in 2027. The company has run its process on more than 20 antibodies, including nanobodies, antibody fragments, and polymer-conjugated antibodies, as well as peptides, enzymes, and insulin, while maintaining their activity.

Worrall describes the potential impact on administration as “almost a game changer.” Because of concentration constraints, he says, the market has moved toward high-volume products that may require hyaluronidase or large devices such as on-body injectors, with larger volumes typically taking 2 to 10 minutes to deliver.

In initial work with Midas Pharma and Gerresheimer using the Gx Inbeneo autoinjector, Worrall says Nanoform delivered about two and a half times the current Herceptin dose in less than one-tenth of the time. He sees that as a potential enabler of at-home administration, using a prefilled syringe or autoinjector stored at room temperature. “So we really think it could be potentially game-changing,” Worrall says.

AAPS PharmSci 360 2026 took place October 24–28 in New Orleans. To explore more of our conference coverage, click here.

Watch the first part of this interview here.

About the Speaker

Chris Worrall, PhD, vice president of US business development, Nanoform

Chris Worrall is vice president of US business development at Nanoform, based in San Diego. A synthetic chemist by training, he holds a PhD in synthetic chemistry and has spent about 19 years in particle engineering. His work focuses on how controlling the morphology and shape of particles influences their performance in formulations. Initially concentrated on small molecules, his work now spans both small- and large-molecule products, including approaches to formulating biologics at high concentrations.

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