Cell-based assays offer most promise for biologic’s safety, efficacy, and treatment potential

Cell-based assays are one of the most promising systems to assess not only the safety and efficacy of an existing biologic, but also the potential of a new treatment modality. The core of the assay is the cell, composed of hundreds of complex molecules that regulate the pathways necessary for vital cellular functions. Because a biotechnology-derived product could disrupt any of one of these pathways, it is important to examine the effects of the biologic within the context of the cell. Cell-based assays have undergone marked development recently as current screening technologies progress toward cost-effectiveness and biological significance. Both proteomics and genomics can rapidly identify potential new therapeutic targets, but these targets require the determination of cellular endpoints. Cell-based functional assays are being used for target identification and validation, for monitoring cellular events, and for screening compounds for efficacy and biosafety. Here at Lancaster Labs, we are responsive to research trends and customer needs. We can provide innovative ways to use cell-based assays that directly measure therapeutic activity, simply and efficiently. Lancaster Labs can offer a variety of readout assays for cellular processes that can be readily applied to the requirements of regulatory testing. These assays examine intracellular processes to obtain high quality safety, potency, toxicity, or ADME data and may also be converted to examine the immunogenicity of a therapeutic compound. Additionally, Lancaster Labs can assist with method development of cell-based assays, as well as cell line characterization and qualification. Cell-based assays provide clients with relevant information and reduce the time and expense of animal trials. Moreover, the ability to track the behavior of individual cells over time permits data gathering on functional behavior not available in any other kind of assay. Some cell-based assays that are available at Lancaster Laboratories include: Cytotoxicity Proliferation Cytokine induction Angiogenesis Differentiation Apoptosis Receptor Activation and Cell Signaling Neutralization For more information on Cell Based Assays or other pharmaceutical capabilities, please contact your project manager, or Pharmaceutical Business Development at (717)-656-2300.