COMPANY DESCRIPTION
Eurofins BioPharma Product Testing offers complete CMC Testing Services for the Bio/Pharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through our broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology.
Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.
We offer the ability to manage your testing programs more efficiently through your choice of three unique service models, including our award-winning PSS Insourcing Solutions®, Full Time Equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals.
FACILITIES
With a global capacity of more than 2,200,000 square feet of facilities and over 45 locations worldwide, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market.
Our local presence with 14 sites across the US, including PA; MI; MO; NC; FL; IN; NJ; and CA, ensures personal service backed by a unique global breadth of harmonized capabilities that supports all functional areas of bio/pharmaceutical drug development.
COMPREHENSIVE SERVICES
- Method Establishment (Development, Feasibility, Optimization, Verification, Qualification, Validation, Transfer)
- Characterization
- Raw Material Testing
- Critical Reagents/Reference Standard Management
- Residual Impurities Testing
- Release Testing (Strength/Content, Identity, Purity, Product/Process Related Impurities, Safety)
- Stability Testing and Storage
- Sterile (Compendial and Rapid) and Non-sterile Microbiology Testing
- Cell Bank Manufacturing and Characterization
- Viral Clearance & Viral Safety Testing
- Bioassay & Potency Testing
- Extractables & Leachables Testing
- Container, Packaging & Closure Integrity Testing
- Functional Testing and Failure Analysis
- Shipping Studies
- Disinfectant Efficacy/Cleaning Validation Studies
- Environmental Monitoring
- Facility and Process Validation
- Organism Identification
- Formulation Development/Testing
- Custom Synthesis & Radiolabeling
- Sterile Fill/Finish Manufacturing
- Clinical Trial Material Support
- Scientific Consulting