ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

  Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

• Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

  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.

• Choosing A Formulation And Process Approach To OCR Products

  Do you want to develop an oral controlled release (OCR) product? Understand the options and their ramifications as the first step toward devising a plan.

• Spray Drying To Enable New Inhaled Drug Products

  The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.

• Combining Powdose® And Diffucaps® For Precise Solid Oral Dosing

  Combining POWDOSE® and Diffucaps® enables precise, individualized solid oral dosing—improving drug delivery, patient compliance, and therapeutic outcomes in personalized medicine applications.

• Using 505(B)(2) To Streamline Approval Of Combination Products

  In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

• Deploying A Circular Economy For Medical Devices

  A circular economy prioritizes sustainability throughout the supply chain by eliminating waste, circulating products and materials, and regenerating nature.

• Unlocking New Possibilities For Treating Rare Genetic Diseases

  With over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.

• De-Risking The Transition From Vial To Drug-Device Combination Product

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• Developing A Multi-Drug Combination, Antiparasitic Drug For Dogs

  Discover how it worked to manufacture clinical supplies of flavored tablets with multiple APIs in just six months while ensuring content uniformity and stability.