ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Largest LOE Event In US Pharma History

  Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

• Streamlining The Path To Market For Generic Drug-Device Combinations

  Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.

• Developmental Testing Of IV Solutions

  As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

• The Growth Of Sterile Injectables

  Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

• Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs

  Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

• Responding To Trends In Prefilled Delivery: Component Assessment And Selection

  Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

• FAQs On The Revised EU GMP Annex 1: Volume 7

  Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

• Delivering Market Success For Pharma Partners From Concept To Patient

  The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.

• 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.

• Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1

  Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.