Molecular and Cell Biology
Eurofins Lancaster Laboratories supports your biopharmaceutical products with a comprehensive range of molecular and cell biology services, including assays to support characterization of cell lines and the testing of unprocessed bulk and final product.
Why Choose Eurofins Lancaster Laboratories?
- We have state-of-the-art molecular biology laboratories, including segregated and controlled suites for qPCR.
- We offer industry-leading experience in the development, optimization, qualification and validation of product-specific cell-based and non-cell-based potency assays that meet regulatory guidelines for all phases of the development cycle.
- Validated assays to detect residual DNA in bulk product from a wide range of host cells including CHO, E. coli, human, mouse and BHK
- Validated assay to support viral safety and inactivation studies, including xMuLV and MVM
- Capability to develop and validate client specific assays
Cell-Based and Non-Cell-Based Potency Assays.
- Development and validation of assays using multiple formats, including absorbance, fluorescence, time-resolved fluorescence and luminescence
- 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
- Development and validation of client-specific potency assays to support product release
- Assay for host cell protein analysis
- Impurity assays including protein A
- Assays perform in compliance with USP <87> and ISO 10993-05
Facilities and Equipment
- Dedicated and controlled laboratories for qPCR analysis, including segregated reagent preparation, sample extraction and amplification suites
- Applied Biosystem 7500 FAST qPCR systems
- Molecular Devices M2 and M5e Plate Readers
- Beckman Coulter Vi-Cell™ Automated Cell Counter
- Thermo Fisher Scientific Nanodrop
- Dedicated Cell Based Assay Lab