Molecular and Cell Biology

Test Articles

We offer services in support of these test articles.

 
 

Molecular and Cell Biology

We support your biopharmaceutical product 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 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.

Leadership of Group:

 

Mark Kaiser – Director 26 years with Lancaster Laboratories

Weihong Wang, Ph.D. - Manager9 years of industry experience

 

 
 

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 insure 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.

Contact

Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.

Facilities and Equipment

  • Dedicated and controlled laboratories for PCR 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.