Articles, App Notes, Case Studies, & White Papers

  1. Data-Driven Innovation Is Drug Delivery's Next Evolution 7/23/2025

    To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.

  2. Best Practices For Ensuring Quality In Biologic Products

    New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

  3. 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.

  4. Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

    Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

  5. FAQs On The Revised EU GMP Annex 1: Volume 8 2/4/2026

    Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

  6. Hospital To Home: What It Means For Patients, Providers And Medical Devices 4/16/2025

    Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.

  7. Functional Performance Of Stoppers To Support Multipuncture Use

    Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

  8. Expanding Home-Based Care With A Next-Gen On-Body Delivery System 10/20/2023

    As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

  9. Maintaining Sterility Through Precise Component Design And Manufacture 4/21/2026

    Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

  10. Evaluation And Identification Of Subvisible Particulate Matter In Injections

    Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.