Articles, App Notes, Case Studies, & White Papers

1. Q&A: Navigating PFAS In Medical Devices 1/15/2025

   Explore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.

2. A Continuous Electroporation System For Viral Gene Therapy 7/8/2024

   Explore the development work involved for the individual technologies that make up an innovative and scalable, chemical-free continuous viral vector production platform.

3. Rational Design And Development Of Long-Acting Injectable Dosage Forms 1/26/2022

   The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

4. Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations 9/3/2024

   The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

5. 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.

6. Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk 1/18/2022

   Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

7. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

   The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

8. Reduce Costs And Improve Adherence For Self-Administration Of Biologics

   There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy. 

9. Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

   Characterizing a molecule's identity enables efficient process development and regulatory compliance. To achieve this, sponsors must leverage advanced analytical techniques that illuminate structure and purity.

10. When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

    If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.