Clinical Report: ten23 health and BD Partner to Address Demand for Self-Administered Therapies

Overview

ten23 health and BD have formed a collaboration to enhance the commercialization of the BD Libertas™ wearable injector, facilitating the subcutaneous delivery of large-volume drugs. This partnership aims to streamline the development process for biopharma companies, reducing risks and improving patient usability.

Background

The demand for self-administered therapies is increasing, particularly for biologics that require large-volume subcutaneous delivery. This collaboration addresses the need for efficient supply chain solutions and regulatory pathways, which are critical for the timely introduction of innovative therapies to the market. The BD Libertas™ wearable injector represents a significant advancement in drug delivery technology, potentially improving patient experiences and outcomes.

Data Highlights

No numerical data or trial data provided in the source material.

Key Findings

• Collaboration between ten23 health and BD aims to support commercialization of the BD Libertas™ wearable injector.
• The BD Libertas™ injector allows for the subcutaneous delivery of high-dose biologics, transitioning from IV to SC administration.
• ten23’s Line 0 enables testing and optimization of cartridge compatibility and filling processes without GMP production delays.
• The partnership is designed to enhance supply chain readiness and facilitate smoother regulatory pathways for biopharma companies.
• Subcutaneous delivery of biologics has been validated through recent FDA approvals, demonstrating comparable efficacy to IV delivery.

Clinical Implications

Healthcare professionals should consider the benefits of self-administered therapies for patients, as they may enhance adherence and convenience. The collaboration between ten23 health and BD could lead to more efficient pathways for bringing innovative therapies to market, ultimately improving patient access to advanced treatments.

Conclusion

The partnership between ten23 health and BD represents a strategic response to the growing demand for self-administered therapies, with the potential to significantly impact the landscape of drug delivery. Continued advancements in this area are essential for improving patient care and treatment outcomes.

References

1. FDA, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, 2024 -- Guidance Document
2. FDA, FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection, 2024 -- Approval Announcement
3. Navigating large-volume subcutaneous injections of biopharmaceuticals, PMC, 2023 -- Systematic Review
4. npj Digital Medicine — Policy and reimbursement strategies to improve patient access to prescription digital therapeutics
5. ADA News — ADA offers discounted access to Talkspace Therapy
6. The ASCO Post — Expert Point of View: Elisabeth I. Heath, MD, FACP, and Oliver Sartor, MD
7. The ASCO Post — Expert Point of View: Elisabeth I. Heath, MD, FACP, and Oliver Sartor, MD
8. ten23 health Press Release
9. Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products | FDA
10. FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection | FDA
11. Navigating large-volume subcutaneous injections of biopharmaceuticals: a systematic review of clinical pipelines and approved products - PMC