Articles, App Notes, Case Studies, & White Papers

  1. Avoiding The Pitfalls Of LNPs And Complex Formulations

    Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

  2. 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.

  3. Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture 3/1/2022

    The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

  4. Capsule Formulation Development: From Dosage Forms To Filling 5/4/2022

    Capsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.

  5. The Role Of Psychological Principles In Med Device Training Design 6/19/2024

    Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users.

  6. From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

    Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

  7. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

  8. Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product Quality 5/12/2026

    Strengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products.

  9. Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells 7/20/2023

    Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.

  10. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.