ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Crystallization Process Dev: Ramping Up Bench-Scale Control

  Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

• Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

  Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

• 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.

• Q&A: Navigating PFAS In Medical Devices

  Explore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.

• A Smarter Strategy For Optimizing Oncology Drug Products

  John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.

• Four Special Fill/Finish Considerations For Vaccine Production

  Examine considerations regarding the handling and process for fill/finish to ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost.

• 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.

• FAQs On The Revised EU GMP Annex 1: Volume 8

  Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

• Lyophilization Contract Manufacturing Services: What To Know

  Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.