Infusion Drug Delivery Resources

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.