ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 4 Factors Affecting Solubility Of Drugs

  Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.

• Formulation Development For Injectables

  A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.

• 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.

• Selecting A Strategic Partner For Your Combination Product

  It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.

• Design Success Combined With Expertise In Testing And Raw Material Selection

  Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

• Realizing The Promise Of New Approach Methodologies (NAMs)

  NAMs are transforming risk assessment. Learn how integrating advanced in vitro models and computational tools can improve efficiency, reduce costs, and strengthen regulatory decision-making.

• De-Risking Visible Particles Through Component Selection

  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• Successfully Navigating Opportunities With On-Body Delivery Systems

  Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.

• A Practical Packaging Components Checklist For Emerging Biotechs

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

• Contract Design And Development Vs. In-House: How To Find The Best Fit

  Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.