Process-related impurities such as host cell DNA and host cell proteins may have adverse effects on product quality and pose safety concerns for cell and gene therapeutic (CGT) products. These impurities must be removed to the lowest possible level in order to meet regulatory requirements, not only to ensure product safety, but also to help understand the capabilities of the manufacturing process. Therefore, throughout product development, the presence of residuals should be monitored. At WuXi Advanced Therapies, several qPCR/ddPCR based methods for residual DNA, and ELISA for residual protein are developed and qualified per ICH Q2(R1) to meet development and regulatory expectations. The knowledge and experience gained on residual assays also enables fast assay development for product-specific residual quantitation from different client requests.
In this webinar, we will explain the assay procedure, sensitivity, linearity, range, as well as sample requirements for residual DNA (E1a, 18S, SV40, kanamycin, etc.), host cell proteins, Benzonase, Denarase, BSA, AVB, and mycoplasma.
Since completing our new R400 lab dedicated to GMP testing, our testing capacity has doubled. Together, with state-of-art technologies utilized in assay development, experienced assay validation, and transfer knowledge, WuXi Advanced Therapies is committed to providing continuous development, validation, and testing services for residual DNA/protein and mycoplasma detection with reduced turnaround times.Key Takeaways:
- Regulatory guidelines for residual DNA/protein and mycoplasma in CGT products.
- Assay validation and transfer services provided by WuXi Advanced Therapies for CGT products.
- Customized methods developed and validated for CGT products.
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