Some of medicine’s greatest innovations started with a simple question, “What If?” What if tiring hospital visits could be completely eliminated by creating an on-body injector which could allow patients to receive vital drug dosages at home?

Beyond the strong business case, I had a personal motivation. I was driven by the words of a close friend suffering from skin cancer who said, “Wouldn’t it be nice if I could do that simple shot in my own home?”

In recent years there has been considerable interest in on-body injectors from pharma companies developing biosimilars of Amgen’s Neulasta (pegfilgrastim). This drug is delivered as a single 0.6 mL subcutaneous injection one day after a course of chemotherapy, in order to prevent neutropenia and therefore reduce risk of infection. Amgen’s Onpro on-body injector device was adapted from an insulin pump technology.  By contrast, one-time delivery of a 0.6 ml bolus of pegfilgrastim takes place over a period of minutes. While the drug must undoubtedly be delivered accurately and safely, this does not present the same level of challenge as delivery of insulin – and can therefore be achieved with a device that is smaller, less sophisticated and less costly than a modified insulin pump or other relatively complex electromechanical technology.

I was intrigued by this possibility, as was our development team. Creating on-body delivery devices represented the next step in E3D’s drive to solve injection-related challenges by delivering suitable device platforms for subcutaneous or intramuscular delivery of medications outside of a clinical environment.

While working on the new on-body device, E3D team looked at several key issues including the device’s size, relative complexity and estimated manufacturing costs. Our research determined on-body devices for drug delivery should ideally meet the following criteria:

  • Usability – replicate the user experience already introduced to market
  • Pre-loading – loaded with the drug by hand from a PFS and applied to the patient’s skin by a healthcare professional
  • Delivery –injection administration within a specified time – automatically.
  • Stable – doesn’t protrude too high from the patient’s skin and cannot be easily dislodged from a patient’s body between device placement and injection.
  • Reduces risk
  • Simplified design – reduce the size and complexity of the device to enable cost-effective manufacture

Following extensive R&D and usability testing, E3D recently introduced its On-body Bolus Injector (OBI), which met all the defined criteria, specifically developed to deliver bolus subcutaneous injections of drugs at the desired injection rates — as cost-effectively as possible and with minimal need for patient intervention.

The OBI-1 device for pegfilgrastim is configured to be used in a similar manner to the Onpro device which is already approved and used with the originator’s Neulasta product. OBI-1 incorporates a timer which results in the patient automatically receiving their bolus injection over approximately one hour — 27 hours following attachment of the device.

The OBI device technology platform offers significant advantages in the delivery of other injectables. Because OBI has only one moving part, it represents a device platform which is compact, inherently robust, economical, readily scalable for any dose volume, and suitable for either manual filling of drug or pre-loaded with the relevant drug.

Whilst the OBI-1 is designed specifically for 0.6 mL dose of pegfilgrastim, and for manual filling of its reservoir by a healthcare professional, E3D recognises that application of the OBI platform for other drugs will typically require injection of higher dose volumes; with a single micro-cell is capable to deliver up to 20 mL, allowing OBI devices to be readily scaled for such dose volumes, viscous liquids, addressing an increasingly prevalent requirement for emerging drug products in a configuration which incorporates pre-filled primary containers (in glass or other materials) which are suited to established drug-filling, handling, sterilisation and assembly processes.