Innovating in the viscosity design space with a new 2.25 mL autoinjector platform

Extending its patient-centric BD Intevia™ Disposable Autoinjector platform, BD builds on past successes while meeting the requirements of new, highly viscous, high-volume biologics for chronic diseases

Large molecules

The market for monoclonal antibody-based drugs (mAbs) has undergone significant growth. These drugs are often characterised by large molecules requiring administration in large injection volumes and/or high concentrations. These proteins require parenteral administration via intravenous or SC injection, due to their low bioavailability via other routes. This can present a challenge for existing SC autoinjector technologies that have been limited to lower viscosities and volumes.

With the launch of the BD Intevia™ disposable autoinjector platform, BD offers a range of devices combining an autoinjector and a prefillable syringe in one integrated system specifically designed for high-viscosity, high-volume biologics. Created using BD’s quality-by-design approach, the BD Intevia™ 2.25 mL disposable autoinjector is a robust and integrated two-step, push-on-skin device that serves a broad design space, providing pharmaceutical companies with additional degrees of freedom and flexibility in drug formulation. The BD Intevia™ 2.25 mL disposable autoinjector delivers drugs with viscosities up to 40 cP safely and effectively. (3, 4) Pharmaceutical companies can adapt the BD Intevia™ 2.25 mL disposable autoinjector to deliver a range of drug volumes and viscosities without any need for customisation of the system or of its components. (3)

8 mm needle technology

The BD Intevia™ 2.25 mL disposable autoinjector integrates the BD Neopak™ XtraFlow™ 2.25 mL glass prefillable syringe, featuring innovative 8 mm needles with Thin Wall (TW) cannula technology (Figure 1). BD Neopak™ XtraFlow™ glass prefillable syringes are characterised by breakage resistance, design quality, autoinjector compatibility and dimensional precision for dose accuracy. (3) By directly addressing many of the risk factors that can cause development delays, (5, 6) BD Neopak™ XtraFlow™ glass prefillable syringes contribute to reduced time to market and optimised commercialisation of biopharmaceuticals. (6)

The BD Neopak™ XtraFlow™ glass prefillable syringe simplifies the burden of device integration faced by pharmaceutical companies. With its robust integration into the BD Intevia™ disposable autoinjector platform, the BD Neopak™ XtraFlow™ glass prefillable syringe helps eliminate the risks associated with the integration of components from diverse manufacturers, (4) as well as the risks associated with the customisation of the secondary device.

The integration of the BD Neopak™ XtraFlow™ glass prefillable syringe supports simpler adaptation to drug volumes and viscosities and reliable combination product performance. This may contribute to cost savings for biopharmaceutical partners, (6) while also contributing to comfort, safety and convenience for patients. (1, 4)

Customization not required

With BD Intevia™ disposable autoinjectors, one device configuration addresses a broad range of viscosities and volumes without the need to customise system and subsystem components. This high degree of flexibility is made possible by accommodating the demands of different viscosities and volumes solely through the parameters of the needle integrated into the Neopak™ XtraFlow™ glass prefillable syringe. By using a shorter needle and increasing its inner diameter without increasing the external diameter (by reducing the thickness of the needle wall), injection force is reduced by up to 46% compared with a commonly used 12.73 mm needle. (7) This is achieved without compromising needle robustness (8) or increasing pain perception. (9)

To manage a range of viscosities and injection volumes, BD Neopak™ XtraFlow™ 2.25 mL glass prefillable syringes are available with 27G Ultra-Thin Wall, 27G Special-Thin Wall and 29G Thin Wall 8 mm needles. Thanks to BD Intevia™ 2.25 mL disposable autoinjector and BD Neopak™ XtraFlow™ 2.25 mL glass prefillable syringe system, a single autoinjector is equipped to handle biologic formulations with viscosities ranging from aqueous to 40 cP and fill volumes up to 2.25 mL.

Patient and partner centricity

The BD Intevia™ disposable autoinjector platform supports pharmaceutical companies that wish to take the lead in patient comfort (1) in the injection of biologics at dose volumes of up to 2 mL via SC delivery. The platform is the direct of result BD’s patient-centric design approach and commitment to developing drug delivery solutions tailored to home care, with the aim to improve patient adherence to chronic disease treatments.

BD offers a range of services and data to support its customers’ combination product development programs. BD also performs extensive preclinical and clinical studies to help de-risk combination product development processes and enable a reduced time to market.

Globally recognized for design excellence

The BD Intevia™ autoinjector platform has earned BD the Frost & Sullivan Global 2020 Technology Innovation Award in the autoinjector drug delivery device market. It is also the recipient of the global Good Design Award, the world’s most prestigious, well-recognised and oldest design awards programme, organised annually by The Chicago Athenaeum Museum of Architecture and Design in cooperation with the European Centre for Architecture, Art, Design and Urban Studies and Metropolitan Arts Press, Ltd.

REFERENCES

1. Li Z, Easton R, “Practical Considerations in Clinical Strategy to Support the Development of

Injectable Drug-Device Combination Products for Biologics”, MAbs, 2018, Vol 10(1), pp 18–33.

2. “Validation Study of BD Intevia™ 1 mL Two-Step Disposable Autoinjector”. Internal Study, 2019; Becton, Dickinson and Company.

3. “Design Input Specification for BD Intevia™ 2.25 mL”. Internal Report, 2017; Becton, Dickinson and Company.

4. “PHS-20-LVA06 HF Late Formative Study for BD Intevia™ 2.25 mL Two-Step Disposable Autoinjector formative study”. Internal Study, 2020; Becton, Dickinson and Company.

5. Rathore, N, et al, “Variability in Syringe Components and its Impact on Functionality of Delivery Systems”. PDA J Pharm Sci Technol, 2011, Vol 65(5), pp 468–480.

6. “System Integration Challenges in Combination Products for Injectable Drugs”. Internal Study, 2019; Becton, Dickinson and Company.

7. “Injection Time and Ejection Force Calculation”. Internal Study, 2020; Becton, Dickinson and Company.

8. “BD Neopak™ XtraFlow™ Needle Resistance Simulation”. Internal Study, 2020; Becton, Dickinson and Company.

9. Pager, A, et al, “User Experience for Manual Injection of 2 mL Viscous Solutions is Enhanced by a New Prefillable Syringe with a Stacked 8 mm Ultra-Thin Wall Needle”. Expert Opin Drug Deliv, 2020,

Vol 17(10), pp 1485–1498.