Infusion Drug Delivery Resources

1. 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.

2. 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.

3. Rational Design And Development Of Long-Acting Injectable Dosage Forms 1/26/2022

   The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

4. Contract Design And Development Vs. In-House: How To Find The Best Fit 3/21/2024

   Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

5. 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.

6. Wearable Injectors: An Alternative To Traditional Intravenous Administration 3/24/2022

   See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

7. Bag Flling Is Now Possible In The United States 2/10/2023

   Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).

8. Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway 1/24/2022

   Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

9. 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.

10. 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.