Biopharmaceutical Services

Molecular and Cell Biology

Test Articles

We offer services in support of these test articles.

 
 

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.

Services Available

qPCR

  • 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

ELISA

  • Development and validation of client-specific potency assays to support product release
  • Assay for host cell protein analysis
  • Impurity assays including protein A

Cytotoxicity

  • 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