Biopharmaceutical Release Testing
To support your commercial product and clinical trial material release testing needs, Eurofins BioPharma Product Testing offers the capacity and breadth of capabilities to test your formulated bulk, final product or in-process materials in a timely manner.
We test materials against specifications for identity, purity, potency, impurities, physical properties and safety under strict cGMP compliance, and we customize individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible.
Our multi-shift laboratory operations are designed to provide extensive capacity for larger volume release programs, as well as flexibility for smaller programs in a manner that allows for aggressive cycle times.
Our release testing services are backed by an outstanding scientific approach to problem solving and extensive expertise in Method Development and Validation.
Why Choose Eurofins BioPharma Product Testing?
- We have in-depth experience working with every modality and have the flexibility and extensive instrument capacity within our team to meet the ever-changing demands of production schedules and timelines.
- We are a center of excellence for development, optimization, and transfer of in vitro bioassays for potency.
- Our breadth of capabilities allows us to perform all testing of even the most complex conjugated molecules at one laboratory.
- Our global capabilities allow us to support your EU batch release requirements.
Our Experience Includes
- Therapeutic Proteins (MAbs, Biosimilars, Fusion & Recombinant)
- Synthetic Peptides
- Therapeutic Enzymes
- Cell/Gene Therapy
- Development and validation of cell-based bioassays using multiple formats, including absorbance, fluorescence, time-resolved fluorescence and luminescence as well as binding and competitive ELISAs.
- Assay optimization to eliminate sources of variability and ensure consistent performance for QC release.
- Multiple software packages available for data analysis, including Softmax Pro and StatLIA.