Injectable Drug Delivery Resources

1. Design Verification Testing Of Combination Products 7/12/2024

   Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

2. USP <382>: Think Systems, Not Components

   This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

3. How To Ensure Correct Component Selection When Outsourcing To A CMO 3/22/2023

   A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

4. 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.

5. Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products 3/7/2024

   Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.

6. Fixtures And Surrogates For Combination Product Performance Testing 5/16/2025

   The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

7. How DFM Promotes Scalability, Repeatability, And Profitability 6/28/2024

   Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

8. Container Closure Integrity Evaluation For Cell And Gene Therapies

   With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

9. How To Simplify Your Move From A Vial To A Prefilled Syringe 9/9/2024

   Explore market trends that could impact the lifecycle strategies for your drug product and its packaging. Careful selection of drug packaging can save time and support a successful transition to new formats.

10. 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.