ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• FAQs On The Revised EU GMP Annex 1: Volume 6

  The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

• 4 Most Common Reasons For Medical Device Material Failures

  Material failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.

• A Risk-Based Approach To Injectable Combination Product Development

  Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

• Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products

  Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.

• Addressing Regulatory Challenges For Ophthalmic Combination Products

  Classifying eye drops as combination products complicates approval. Learn how identifying the primary mode of action early and aligning dual quality frameworks prevents costly launch delays.

• Single Source Partner: Seamless Approach To Deliver World-Class Treatment

  Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements. 

• Expanding Opportunities For Inhaled Drug Delivery

  Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

• 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.

• Seven Softgel Myths: Are You Missing Your Softgel Opportunity?

  Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?

• Early Solid Form Screening To Guide Drug Development

  Conducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.