BIOTECHNOLOGY
Safety remains a concern for biomanufacturers
CELL AND GENE THERAPIES HOW TO DE-RISK Dr Yvonne Collins explores the technical advances that are enabling safer biomanufacturing A
s the number of cell and gene therapies approved and entering clinical trials grows, so does the need for standardisation and
robust quality control (QC). Compliance with QC standards is a basic requirement for products manufactured under good manufacturing practices (GMP), which aims to minimise risks such as contamination.
When manufacturing cell and gene therapies there are many potential sources of contamination including, residual host cell DNA (HCD), mycoplasma and other microorganisms. Compared with conventional pharmaceuticals, there is also a limited amount of final product available for QC testing and they have a drastically shortened shelf life.
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www.scientistlive.com To boost effectiveness and ensure patient
safety, manufacturers must identify and mitigate the risk of contamination along the entire bioprocessing workflow. Many turn to quantitative PCR (qPCR), but it cannot deliver absolute quantification as it relies on standard curves, creating variability and bias. Regulators have recognised the need for new approaches, and the industry is responding with novel innovations in analytics, such as digital PCR (dPCR).
DIGITAL PCR TAKES QUALITY CONTROL TO THE NEXT LEVEL dPCR is increasingly becoming the technology of choice for robust manufacturing and QC primarily because it ensures absolute quantification without
standard curves. Using microfluidic nanoplate technology, the QIAcuity digital PCR system integrates sample partitioning, thermocycling and imaging into one system. Tis results in a simplified workflow, faster time to results, higher throughput and enhanced multiplexing. Well-designed dPCR assays offer precise and sensitive contaminant testing of mycoplasma and residual host cell DNA, ensuring the potency, purity and safety of the therapeutic product.
RESIDUAL HOST CELL DNA Residual host cell DNA (HCD), often carried over during viral vector production, poses considerable safety concerns, including oncogenicity,
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