Managing Risks in Injectable Drug Delivery: Solutions for Today’s Drug Products and Tomorrow’s Novel Applications

Join West experts to gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery covering:

• EU GMP Annex 1
• Medical Device Regulations
• New solutions for aseptic filling of Cell and Gene Therapies

EU GMP Annex 1: West Contamination Control Strategy

The revised EU GMP Annex 1 puts a strong focus on primary packaging materials. As drug manufacturers assess their Contamination Control Strategy (CCS), one must inevitably consider the quality and control of materials from third party suppliers that enter the aseptic process. A critical success factor to a CCS is the ability of your suppliers to create and maintain a holistic CCS approach. This session will demonstrate how West addresses EU GMP Annex 1 requirements through the implementation of a comprehensive CCS across its global network to ensure best practices and continual improvement.

Modern PFS solutions: West MDR data package

Modern drug development including regulatory requirements coming from Annex 1 and Medical Device Regulation (MDR) are driving market trends. A case study on NovaPure® plungers will give some insight on how to manage the market requirements including quality attributes and performance criteria. How to easily access the right documentation to help improve your MDR journey to market will also be reviewed.

Daikyo Crystal Zenith® Ready-to-Use Nested Vials in Tub: New Solutions For Aseptic Filling For Gene Therapy

Cell and Gene therapies are a rapidly growing area and can been foreseen for example for new vaccine therapies as a break-through technology. Identifying packaging materials that meet the high demands of advanced therapies is challenging. The product features of the new Daikyo Crystal Zenith Ready-to-Use Nested Vials in Tub will be presented including use cases to fulfill the specific requirements.