HN-Cell and Gene Therapies

Analyzing Key Purity Markers CASE STUDY Identify potential contamination C&GT products must be free from all process and product-related biological and chemical contamination. SGS provides innovative solutions to identify any harmful contaminants which can highlight areas where product purity needs to be improved. SGS has a wealth of experience in techniques such as:

• Development of potency assays (MTS) to assess cell proliferation, cell viability, and cytotoxicity. • Detection of residual host cell DNA, RNA, and host cell proteins. • Advanced and sensitive chromatographic and mass spectrometry (MS) methods for the detection of process and product contaminants.

Our array of testing solutions will evaluate your product’s purity, underscoring issues that need to be addressed. They will also help you ensure it is free from extraneous material before it is assessed by regulators – and before it hits the market.

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