Articles, App Notes, Case Studies, & White Papers

  1. Navigating PFAS In Medical Devices 7/29/2024

    Review how an experienced partner can help you navigate the shifting regulatory landscape for your medical device.

  2. The Formulation Development Journey

    Successful formulation journeys start with a roadmap where scientific studies and decision points create a route for understanding a molecule’s personality and its viability to help it along the way to the patients.

  3. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

  4. White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges 10/16/2024

    Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

  5. Managing Poor Solubility With Cutting-Edge Formulation Approaches 8/24/2022

    An increasing number of poorly soluble APIs are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.

  6. Overcoming A Failed Design Verification Test For Your Delivery Device 4/6/2022

    If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.

  7. Key Considerations For Packaging Solutions For Cell And Gene Therapies

    Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

  8. Overcoming Limitations To Achieve Uniform Dosing 1/24/2022

    An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

  9. The Challenges And Opportunities Of Real-World Evidence: Part I 12/12/2024

    Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

  10. Liposomes – Challenges And Opportunities

    Liposome technology is an effective drug delivery tool but still presents difficulties. Learn how developers are meeting these challenges and the opportunities for advancement to maximize liposome usefulness.