Skip to main content
2023 PharmSci 360 Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Formulation and Delivery - Biomolecular

Category: Poster Abstract

(W1030-02-10) Evolving Component Technologies to Meet the Needs of Large Volume Injections

Wednesday, October 25, 2023
10:30 AM – 11:30 AM ET

    Presenting Author(s)

  • Eric Kurtz, M.B.A.

    Manager, Technical Product Development
    West Pharmaceutical Services, Inc.
    Exton, Pennsylvania, United States

    • Main Author(s)

  • Eric Kurtz, M.B.A.

    Manager, Technical Product Development
    West Pharmaceutical Services, Inc.
    Exton, Pennsylvania, United States

    • Co-Author(s)

  • SC

    Simon Cote

    West Pharmaceutical Services Inc.
    Exton, Pennsylvania, United States

  • CJ

    Christa Jansen-Otten

    West Pharmaceutical Services Inc.
    Exton, Pennsylvania, United States



Purpose: As pharmaceutical companies evaluate the appropriate primary container for their drug product, new strategies must be adopted to mitigate risk during development. While the industry continues to see significant growth for drug products developed in cartridges, there is a trend for pharmaceutical companies to evaluate more complex drug molecules that require higher injection volume or viscosity. These biologics are typically intended for self-administration by the patient and integrate a PFS or Cartridge with a delivery device to optimize safety, dose accuracy, and ease of use. Innovations in the device space, such as bolus injectors, have allowed for delivery of protein-based therapies up to 10 mL and higher. The challenge, however, is that existing plunger and seal technology for cartridges was developed for less complex drug molecules and does not meet the evolving requirements for drug delivery, especially for drug compatibility and injection force. This poster will review the current trends for Cartridge and Self-Injection as well as discuss the challenges with higher volume and viscous drug products during development. The poster will review key decisions during primary container selection, the importance of component integration of glass cartridge and device and give an overview of new approaches in the development of next generation component technology for complex injections.

Methods: Data will be shared on the key critical product requirements, such as break loose & extrusion force profiles (BLE), plunger and seal functionality, container closure integrity (CCI), and machinability performance that can be used to support component selection strategies, integration, and implementation at the pharmaceutical companies.

Results: No fluid leakage was observed over time. With regards to BLE, forces are consistent and far below requested limits over time for 1x and 2x steam sterilized plungers, all speeds 50 and 3.5mm/min. The initial force increases by 4 - 6 N as the speed of the test increased from 3.5 mm/min to 50 mm/min, while at the same time any impact on sustaining force is negligible. The impact of double steam sterilization cycle, representing a worst-case scenario, on higher initial forces could be demonstrated with an increase of 1-2 N compared to 1x steam sterilization. All Helium leak rates of the container closure systems (CCSs) were far below the Kirsch limit for all test points and for both glass cartridges from multiple vendors, demonstrating results about 1000 times lower than the Kirsch Limit. Successful radial movement around bowl and track up feed rails were demonstrated at external machine vendors, along with successful buffering on a distributor plate, providing enough back pressure in the outlet to reach required throughput speeds. No observations of twinning or visible particulates were observed during or after the study. Ultimately the plungers can be sorted with standard sorter systems typically used by the vendor.

Conclusion: The FluroTec(R) 5-10mL Cartridge Plunger mitigates potential risk to patients and enables a smoother journey to market of large volume on-body delivery systems.

Acknowledgements: West and the diamond logo, FluroTec, and Flip-Off are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. Copyright ©2023 by West Pharmaceutical Services, Inc. All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without written permission of West Pharmaceutical Services, Inc..

Features & Benefits

BLE

CCI