Biologics

Human Allogeneic Cell Safety Testing Guide

FDA has posted a draft guidance entitled “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.” The document provides recommendations for determining the appropriate cell safety testing to support a BLA or IND. “Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating,” it says.

The guidance recommends sponsors provide an integrated assessment of the risk of potential contamination with adventitious agents in the electronic Common Technical Document, Section 3.2.A.2 (Adventitious Agents Safety Evaluation) of their IND or BLA submission. It also recommends that this section describe risk mitigation measures, including information on the selection, testing, and safety assessment of cells and cell banks.

The agency notes that the recommendations also apply to genetically modified allogeneic cells that have been transduced with viral and/or plasmid vectors, and cells that have undergone genome editing. However, they do not apply to cell substrates that are used during manufacturing of non-cell-based products such as viruses, gene therapy vectors, or recombinant proteins, it adds.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome