Fill-Finish Support Services
Many drug developers are challenged to find fill-finish options for the broad variety of drug product packaging and containment options available on the market. With a partner that is uniquely positioned to help Simplify the Journey™ from concept to commercialization, drug developers receive the flexibility, quality, speed and expertise they need, with fill-finish support services from early development through small-scale commercialization.
Through our Integrated Solutions program and collaborations with equipment manufacturers and Contract Manufacturing Organizations (CMOs), West can assist drug developers with the following fill-finish services:
- Sample Preparation for Product Testing
- Fill-Finish Implementation Support
- Clinical and Commercial Filling Collaborations
- Analytical Testing
- Program Management
- To simplify product qualification and reduce development risk, West provides comprehensive analytical services for filled containment systems.
- QC Testing
- Release Testing
- Combination Product Testing
Sample Preparation for Product Testing
- During drug product development West supports drug developers by performing small-scale filling services that enable early screening, gross compatibility testing and performance/functional studies.
Fill-Finish Implementation Support
- West’s fill-finish implementation consulting service was established to provide drug developers with support based on West’s unique experience and relationships with various equipment vendors and CMOs. Services include:
- Process Development Engineering Services
- Equipment Vendor and CMO Selection Consulting
- Filling Line URS Consulting
- Change Parts and Machinability Assessments
- Troubleshooting and Investigation Engineering Services
- Technology and Process Transfer Engineering Services
Clinical and Commercial Filling Collaborations
- To facilitate the path to market, West has developed unique collaborations with CMOs to support drug developer needs for clinical and commercial fill-finish manufacturing services.
- West provides integrated program management across device and fill-finish activities, to streamline project execution and simplify the supply chain.
*contingent on safety review
- The Bausch+Ströbel Flex Filler is located in West's Exton facility.
- The Flex Filler is utilized to support West and customer product development, process optimization, troubleshooting, and tech transfer.
- The equipment is in a R&D Lab and not for human use manufacturing.
West and the diamond logo, By Your Side for a Healthier World and Simplify the Journey are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the U.S. and other jurisdictions.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.