ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

  Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

• Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

  A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

• Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

  Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

• Advancing Biopsy Device Performance Through Precision Overmolding And Assembly

  Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• NovaPure Stoppers - The Right Choice For Oncology Drugs

  Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

• Annex 1 – The Brave New World Of Regulatory Compliance

  The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

• Vial Adapter Transfer Device Compatibility With Cell Therapies

  Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

• Safely Navigating The Transition From MDD To MDR

  If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

• Overcome Common Pre-Filled Syringe Challenges Through Partnership

  The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.