Company insight
to 1–2ml; on-body devices can handle much larger volumes, often 5ml or more. This is a crucial factor in bringing more treatments to the home setting without compromising safety or compliance. Drug formulations are becoming more concentrated to reduce the volume required for injection, and there is a strong drive to move away from intravenous delivery to subcutaneous formulations that require far less expertise to administer safely. The push for reformulation to lower the expertise level required to administer a drug is strong, and subcutaneous formulations suit a much broader slice of the patient population, but volume remains an issue. “Volume defines the use case for on-body devices,” Moakes says. “If you have a drug that is administered once a day, it is less practical than a drug that is dosed once a month, and as you reformulate for subcutaneous delivery, the volume may be lower if it is concentrated or higher if it is diluted. You may also need a permeation enhancer, for example, and some drugs can be very viscous, which means they take longer to be infused.
“Injecting something with the consistency of treacle is more painful as the body pushes back against the force,” he adds. “If the choice of formulation means delivering a viscous drug painfully, then an on-body device can slow down the rate of delivery.”
Sorrel is the first on-body device delivering monoclonal antibodies in the immunology space.
play with infusion rate, or stair-step it so the body gets used to the flow of the drug.” Furthermore, while most on-body devices handle the delivery of 5ml, and some can handle 10ml, Sorrel goes further and is capable of handling much greater volumes delivered over time. Indeed, it differentiates itself by both volume and viscosity. It has been intentionally overdesigned to be capable of delivering 20ml at 1ml per minute, or 1ml over several days, and anything in between those extremes.
“Injecting something with the consistency of treacle is more painful as the body pushes back against the force.”
On-body devices can also deliver less concentrated drugs into the body quickly, as their potential design parameters are broad and their use is less constrained by volume and viscosity than autoinjectors or other alternatives. The same principle applies to time and volume. It is accepted that 2.25ml is at the upper end of the range of volume a patient would want to self-administer. With an autoinjector, the length of time it is held to the skin should be less than 30 seconds. Some companies have devices that must be held to the body for several minutes, but the resulting discomfort could be completely avoided by using an on-body device that can spread the delivery of 5ml or more over an extended period.
“If you are pushing more than 2.25ml, can you tolerate that as a patient?” Moakes wonders, “With an on-body device we can
www.worldpharmaceuticals.net
“Also, our competitors either have a proprietary cartridge you must load, or they require some sort of self-filling, like pulling a drug from a vial,” says Moakes. “We can pull directly from a vial or cartridge, so we can use any primary container. We did not choose the proprietary route. And we include an on-board sterilisation process, so no need to load the device in a cleanroom.”
Expanding horizons
Innovation in on-body devices allows them to be used for a growing number of conditions beyond the traditional areas of diabetes and autoimmune diseases. The ability to deliver large, viscous drug volumes opens doors for new therapies in fields like oncology, gene therapy and rare diseases.
In such cases, delivery devices may well become differentiators for pharma companies
offering biosimilar drug therapies or novel compounds. Sorrel is already the first on-body device in the immunology space, delivering monoclonal antibodies, and it is the platform behind the Udenyca on-body injector for large molecule biologics used for patients with neutropenia caused by chemotherapy. As well as being versatile, safe and suitable for an increasing range of drug treatments, including cell and gene therapies, on-body devices also enable the integration of digital technology to enable advanced features like dose tracking, adherence reminders and real-time data sharing with healthcare providers. “Some cell and gene therapies, and some novel compounds in development might cost $1–2m per infusion, so the emphasis goes away from high volume to extreme accuracy to reduce waste, and we can handle that,” says Moakes. “With connectivity, we can measure the impact of a drug in real time. We can deliver an antibody and measure a biomarker, to see whether there is a response.”
If there is one factor that stands in the way of widespread adoption of on-body devices it is the need for patient training to provide the level of confidence in the reliability and efficacy of the technology. But developers are aware of this. Indeed, the mantra at LTS is that a device should be as easy to use as a plaster. Perhaps we stand at the threshold of a new era in which on-body devices will make at-home care the rule rather than the exception for many patients. ●
www.ltslohmann.com 15
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