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CGT (Cell and Gene Therapy) purification refers to the process of isolating and purifying cell and gene therapy products to obtain a final product that is safe, pure, and effective for patient administration. Cell and gene therapies involve the use of living cells or genetic material to treat various diseases, including cancer, genetic disorders, and autoimmune conditions.
The purity of a Cell and Gene Therapy (CGT) product is typically assessed using a combination of analytical techniques. Here are some commonly used methods:
Flow Cytometry: Flow cytometry is a technique used to analyze and quantify the characteristics of individual cells in a heterogeneous population. It can be used to assess the purity of cell-based CGT products by labeling specific cell surface markers and analyzing the distribution of these markers within the population.
qPCR (Quantitative Polymerase Chain Reaction): qPCR is a molecular biology technique used to measure the amount of specific DNA or RNA sequences in a sample. It can be employed to assess the presence of contaminants or impurities, such as residual viral DNA or RNA, in CGT products.
ELISA (Enzyme-Linked Immunosorbent Assay): ELISA is an immunological assay that uses antibodies to detect and quantify specific proteins in a sample. It can be utilized to assess the presence of target proteins or to detect and quantify contaminants or impurities in CGT products.
Western Blotting: Western blotting is a technique used to detect and analyze specific proteins in a sample. It involves separating the proteins based on their size through gel electrophoresis, transferring them to a membrane, and then using specific antibodies to detect the target protein. This technique can be used to assess the presence and purity of specific proteins in CGT products.
Sterility Testing: Sterility testing is performed to ensure that CGT products are free from viable microorganisms. It involves incubating the product under appropriate conditions to allow any potential microbial contaminants to grow. If no growth is observed after the incubation period, the product is considered sterile.
Adventitious Agent Testing: CGT products need to be tested for the presence of adventitious agents, such as viruses, that could potentially contaminate the product during manufacturing. Techniques like PCR, viral culture, and next-generation sequencing are employed to identify and quantify the presence of adventitious agents.
These analytical techniques, along with others specific to the CGT product being assessed, help ensure the purity and quality of the final product, and they are performed as part of the quality control process during CGT production.