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 1,600,000 square feet of facilities and 35 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 four key sites in the US, including Lancaster, PA; Portage, MI; Columbia, MO; and San Diego, 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, Validation, Transfer)
- Release Testing
- Stability Testing & Storage
- Characterization
- Residuals & Impurities Testing
- Raw Materials Testing
- Extractables & Leachables Testing
- Container & Package Testing
- Shipping Studies
- Viral Clearance & Viral Safety Testing
- Bioassay & Potency Testing
- Cell Banking Services
- Critical Reagents/Reference Standards Management
- Disinfectant Efficacy/Cleaning Validation Studies
- Environmental Monitoring
- Facility and Process Validation
- Organism Identification
- Clinical Trial Material Support
- Formulation Development/Testing
- Custom Synthesis & Radiolabeling
Major Product Innovations
LabAccess.com, our innovative online data access tool, offers a timely and secure window to comprehensive laboratory information as projects progress. With LabAccess.com, you can view extensive, live project information such as submitted samples, analysts’ notebooks, chromatograms, approved test results, Certificates of Analysis, raw data packages and invoices.