ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Design Verification Testing Of Combination Products

  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.

• 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.

• How To Ensure Correct Component Selection When Outsourcing To A CMO

  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.

• High-Throughput Platform Propels Gene Editing Therapy Research

  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.

• Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products

  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.

• Building Sustainability Into Medical Devices

  Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.

• Fixtures And Surrogates For Combination Product Performance Testing

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

• Semi-Solid And Semi-Liquid Dosage Forms: What To Know

  Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.

• How DFM Promotes Scalability, Repeatability, And Profitability

  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.

• 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.