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. 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.

  3. Small Is Powerful And Sustained

    Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

  4. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

  5. 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.

  6. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  7. 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.

  8. 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.

  9. Snapshot Of The Parenteral Drug Delivery Market 6/17/2022

    Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.