Cell substrates are often used to manufacture biopharmaceuticals such as cell and gene therapies, vaccines, and other biologics. Due to the inherent complexity of the manufacturing process, monitoring of impurities including host cell components and microbial contaminants is required to ensure the quality and safety of the product.

Microbial testing for mycoplasma and other contaminants traditionally uses growth-based assays. Rapid methods are needed for short shelf-life products like cell and gene therapies. The proposed USP general chapters <77> Mycoplasma Nucleic Acid Amplification Tests and <72> Amplification Tests and Respiration-Based Microbial Methods for the Detection of Contamination in Short Life Products demonstrate how these assays can be implemented to replace growth-based assays. We will provide an overview of ATCC® products that can be used for the validation of these assays.

Residual host cell proteins (HCPs) in biotherapeutic products can pose a risk to patients and to the quality of the product. Mass spectrometry has become an increasingly common approach for the characterization of HCP impurities due to its ability to identify and quantitate individual HCPs. We will provide an overview of the new USP general chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry and related reference materials that support the identification and quantitation of high-risk HCPs.

Residual DNA testing is required for demonstrating clearance of host cell DNA. USP General Chapter <509> Residual DNA Testing contains validated qPCR measurement methods for E. coli and CHO genomic DNA, along with USP Reference Standards. To support the need for highly qualified reference materials for a broader range of biological products, USP and ATCC® have introduced gDNA control materials derived from host cell lines commonly used to manufacture cell and gene therapies, vaccines, and other biologics. We will outline the characterization and utility of these materials.

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