Confidently measure the biological effects of cell and gene therapies. Agilent offers complementary cell-based assays to characterize cell and gene therapy mechanism of action, potency, and critical product attributes to more accurately predict clinical efficacy and safety.

Jul 1, 2022 · Linda Engle of Biogen presented a case study of developing a cell-based potency bioassay for gene therapy products based on adeno-associated viral (AAV) vectors.

In such cases, a bioassay utilizing two cell lines is used, with the first cell line chosen on the basis of resistance to the effects of expression of the therapeutic gene of interest and with subsequent passage of cell lysate onto A549 cells for amplification and detection of the RCA.

We, FDA, are issuing this guidance to provide you, manufacturers of cellular and gene therapy (CGT) products, with recommendations for developing tests1 to measure potency.2 These recommendations...

Potency assays are a fundamental aspect of the quality control of the end cell products and ideally could become useful biomarkers of efficacy in vivo. Here we summarize the state of the art with regard to potency assays used for the assessment of …

cell-based methods continue to evolve in support of gene therapies to assess product potency through gene or protein expression, the increased complex-ity and variation of assay readouts can bring questions on best-practice approaches for method development and anal-ysis.

Jun 18, 2021 · Pluristem relies on in-house, cell-based potency assays using different cell lines on the Synergy HT fluorimeter from BioTek Instruments. Potency assays are critical in assuring the quality and consistency of the product.

Flexible and scalable development and manufacturing services to bring your allogeneic cell therapy from concept to patient. Learn more.

From early discovery to patient delivery, cell therapies depend on analytical assays to help ensure product efficacy and faster vein-to-vein times. A variety of cell types including CAR-T, NK cells, induced pluripotent stem cells (iPSCs), and tumor-infiltrating leukocytes (TILs), have opened the door to potentially treating more patients and ...

Element’s cellular assay experts provide best-in-class cell culture and cell-based bioassay services for biologic drug discovery and development programs.