Articles, App Notes, Case Studies, & White Papers

  1. Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon 9/18/2024

    Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.

  2. A Pathway For Regulatory Success For Devices In Combination Products 10/27/2025

    Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

  3. Safeguarding Cell Therapy Cryopreservation: Primary Containers 5/20/2024

    Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.

  4. The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation 9/15/2023

    The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.

  5. Promising Early Results For New High-Performance DPI 4/28/2022

    This report discusses the benefits of the αeolus technology, a passive, high-performance, high-consistency dry powder inhaler platform concept, and the preliminary performance data from early-stage development.

  6. Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls 9/20/2022

    Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

  7. Leveraging Autoinjector Innovation To De-Risk Biosimilar Development 6/2/2022

    Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

  8. Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges 8/27/2024

    An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.

  9. The Role Of Micronization In The Journey To Drug Product Development

    Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.

  10. Oral Controlled Delivery Of Poorly Water-Soluble Drugs 1/27/2022

    Various drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.