Testing the Next Generation of Self-Administered Biologics:
Large Volume Drug Delivery Devices
Biologic therapies are moving from the infusion chair to the home, thanks to autoinjectors built to handle larger volumes. Here's a look at what's driving that shift and what it takes to test these devices.
For years, many biologic therapies have meant one thing for patients: a trip to the clinic and a lengthy IV infusion. Over the last several years, this has been changing as pharmaceutical companies are increasingly developing autoinjectors capable of delivering larger volumes and high-viscosity biologics. This allows patients to self-administer at home on their own schedule, without requiring an infusion chair or a clinical visit.
This shift grants a significant improvement in patient autonomy, and also brings a set of engineering and testing considerations that scale up alongside the larger drug volume.
From 1-2.25 mL to 5 mL and Beyond
Conventional autoinjectors are built to deliver 1-2.25 mL of drug product. Large volume autoinjectors typically operate using the same core principles, but are generally understood to be anything delivering 3 mL or more. In the devices currently undergoing evaluation by major pharmaceutical companies, we're seeing volumes reach as high as 5.5 mL, while there are devices with capacity of up to 10 mL in development.
That jump in volume isn't a minor adjustment. Higher fluid volumes, or viscosities, introduce different design considerations — including the mechanism that drives the injection and the components required to house and support a larger primary container. Testing these devices thoroughly, as a complete system, before they ever reach a patient, is essential to understanding how they'll actually perform.
Autoinjector testing generally is guided by standards like ISO 11608-5 and the FDA's draft guidance on Essential Drug Delivery Outputs (EDDOs), covering things like dose accuracy, needle depth, activation force, injection time, and audible feedback. Large volume autoinjectors are evaluated against these same fundamental outputs as the underlying measurements.
Why This Calls for a Flexible Testing Approach
At Instron, our Autoinjector Testing System was built as a standard platform that can be configured to handle a wide range of device profiles from smaller-volume autoinjectors up through the large volume end of the spectrum.
A few important considerations come into play with large volume device testing:
- Cartridge-based devices: Some autoinjectors, particularly large volume devices, use a cartridge as the primary container as opposed to a prefilled syringe (PFS). Specifically for the SHL Magnitude(opens in new tab) [formerly Maggie] device(opens in new tab), the cap must be unscrewed to engage the needle and connect the fluid pathway before the injection can begin. Testing this kind of device calls for biaxial capability, which can be added to the system through a Torsion Add-On.
- Audible feedback: Many autoinjectors use an audible click to let the patient know an injection has started and finished. Large volume autoinjectors sometimes instead use a continuous sound for the duration of the injection, with silence indicating completion. Capturing this audio alongside force, dispensed volume, and other test data (via an integrated microphone) gives a fuller picture of how the device communicates with the user during a real injection.
- Needle depth and delivery tracking: The system uses a machine vision camera to measure the injection depth and injection time. This approach is used across the full range of autoinjectors, and is robust enough to handle the broader range of viscosities or injection times that may be seen with large volume devices.
One Platform, Minimal Change Parts
Every drug delivery device is unique, with different cap mechanisms, feedback cues, force and volume profiles, so building a bespoke test system for each one isn't practical. Our approach instead treats the Autoinjector Testing System as a standard platform that gets adapted through add-ons and configuration changes to best accommodate the device being evaluated, with test methods also built around the specific requirements of that device.
One of the design priorities behind the system is keeping the number of change parts to a minimum, so switching between device types on the same test system is straightforward. That matters for labs evaluating a range of devices, since it means less time spent reconfiguring equipment and greater repeatability across testing when the changeover process is simple.
This is where the large volume configuration comes in. The large volume version of the Autoinjector Testing System is built to handle the full range of autoinjector sizes from 1 mL capacity to 5.5 mL using that same minimal change part approach to move between them.
Watching This Space
It's worth noting that, as of the original publishing this article in September 2026, no large volume autoinjector combination product — meaning an approved drug delivered via one of these devices — has been released to market. Device platforms themselves are available from manufacturers for pharmaceutical companies to use in their development efforts, but the R&D phase is still ongoing for the drug products themselves.
Most of what we're seeing is still in the research and development phase, largely driven by pharmaceutical R&D teams evaluating whether a large volume, self-administered format is the right delivery approach for a particular drug candidate. In other words, this is very much an emerging space where device testing plays a central role in shaping decisions that haven't been finalized yet.
Autoinjectors capable of delivering larger volumes represent a meaningful shift in how biologics could be administered, moving high-viscosity, high-volume therapies out of the clinic and into the patient's own hands. As more of these devices move from R&D into later-stage development, having a testing platform built around adaptability, rather than a fixed, single-purpose setup, means it's ready to support whatever comes next in this space.
We'll continue to share what we're learning as this category develops. If you're working on a large volume device and want to talk through your specific testing requirements, our team will be glad to help figure out the right setup.
Frequently Asked Questions (FAQs)
A large volume autoinjector is an autoinjector designed to deliver a larger volume of drug product than a conventional autoinjector. This device format is being developed to support certain biologic formulations that would otherwise require IV infusion in a clinical setting, allowing for self-administration at home instead.
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Published:
September 23, 2026
Written By:
Meredith Bernstein(opens in new tab)(opens in new tab)
Edited By:
Nick Erickson
Reviewed By:
Landon Goldfarb(opens in new tab)(opens in new tab)
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Purpose-built for autoinjector testing, with a large volume configuration that covers the full range of device sizes — supporting full functionality testing for R&D and quality control testing.
Adds biaxial, torsion-plus-axial testing capability for cartridge-based devices that require twist-off cap removal to connect the fluid pathway before injection.
Fixtures and automation designed for prefilled syringe testing, including break loose and glide force, needle penetration force, and cap removal applications.
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About the Author
Meredith Bernstein
Meredith Bernstein(opens in new tab) is the Biomedical Product Manager at Instron, where she leads Instron's strategy for products and customer support across the medical device and pharmaceutical industries. With a primary focus on the drug delivery space, Meredith oversees complex customer projects and provides technical guidance from early inquiry through factory acceptance testing. She also develops novel testing methods for medical devices and pharmaceutical products, ensuring the highest standards in product development and quality. Her meticulous approach, deep technical expertise, and passion for advancing testing processes make her a driving force behind Instron's continued leadership in the biomedical industry.