Injectable Drug Delivery Resources

1. Navigating Regulatory Challenges In Oligonucleotide Therapeutics 12/12/2024

   Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

2. Key Considerations For Selecting Flexible Fillers

   Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

3. Stability Chambers: Testing, Equipment, And Uses 3/7/2023

   Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

4. Key Trends And Developments In Injectable Drug Formulation And Delivery

   As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.

5. Deploying A Circular Economy For Medical Devices 9/10/2024

   A circular economy prioritizes sustainability throughout the supply chain by eliminating waste, circulating products and materials, and regenerating nature.

6. Is It Ever Too Soon To Start Your Performance Testing Assessment?

   Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

7. Container Selection For A Highly Sensitive Drug Product: A Success Story 8/27/2024

   Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

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. Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device 12/2/2022

   Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

10. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.