Articles, App Notes, Case Studies, & White Papers

  1. Aseptic Filling And Processing Considerations For Biosimilars 10/11/2023

    One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

  2. Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device 12/2/2022

    Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

  3. Sustainability Considerations For Drug Delivery Device End-To-End Solutions 6/15/2022

    Learn how to address the gradual unlinking of economic activity from the consumption of finite resources and the removal of waste to support and help prevent a global climate catastrophe.

  4. Trends In Drug Delivery: The Growth Of Cartridge Based Technology

    As pharma companies evaluate the delivery systems for their drug product, there are several reasons why they may select a cartridge-based system compared to a pre-filled syringe or vial. 

  5. Responding To Trends In Prefilled Delivery: Component Assessment And Selection

    Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

  6. Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

    Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

  7. Decoding the FDA Guidance on Essential Drug Delivery Outputs 2/18/2025

    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

  8. Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs

    Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.

  9. 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.

  10. 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.