Infusion Drug Delivery Resources

1. Formulation Development From Preclinical To First-In-Human 1/24/2022

   A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

2. Switching From Vials To PFS And Intravenous To Subcutaneous Formulations 7/25/2023

   Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

3. 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.

4. Computational Modeling Of Injection-Related Tissue Responses 6/15/2022

   Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

5. 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.

6. Delivering The Promise Of Gene Therapy 1/22/2024

   Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.

7. 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.

8. Combination Products: Market Trends And Regulatory Considerations 1/17/2024

   Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.

9. 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.

10. 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.