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From the Blog
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July 01, 2020

Fill-Finish Engineering and Process Development – A Critical Step to Ensuring Product Quality and Manufacturability

Rohit Vora

Rohit Vora

Manager, Fill-finish Enablement

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

Analytical Testing

  • 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.

Program Management

  • West provides integrated program management across device and fill-finish activities, to streamline project execution and simplify the supply chain.

*contingent on safety review

Fill Finish
  • 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.