Infusion Drug Delivery Resources

  1. Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

    Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

  2. Accelerating Gene Therapy With HITSCAN Platform 4/16/2025

    Battelle’s HIT SCAN™ platform accelerates gene therapy by rapidly designing, screening, and optimizing nanoparticle drug delivery systems using high-throughput robotics and machine learning.

  3. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

    Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

  4. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

  5. Considerations In Formulation Development Of Injectable Solutions 2/8/2022

    Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

  6. T Cell Cryopreservation: Comparing Rigid Polymer Vials And Flexible Bags 7/20/2023

    This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.

  7. Is Your Combination Product Drug-Led Or Device-Led? 11/30/2022

    The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

  8. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

  9. High-Throughput Platform Propels Gene Editing Therapy Research 3/1/2024

    Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.

  10. 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices 3/1/2024

    Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.