CAR T-Cell Therapy Manufacturing

CAR T-Cell Manufacturing and Quality Control​​

CAR T-Cell Manufacturing and Quality Control​

Delivery of the CAR gene in CAR T-cell therapies can be accomplished using a variety of tools, such as transfection of mRNA or transduction of a viral vector, such as lentivirus. Transduction using of viral vectors is more efficient and used in currently approved CAR T-cell therapies.​

There is an inherent risk of adverse effects when using a viral vector to manufacture these CAR T-cell therapies. Therefore, measuring the vector copy number with high accuracy and precision is crucial to ensure safety. Additionally, it is necessary to accurately quantify CAR transgene copy number in a batch of transduced T cells. While scaling up production can be challenging to standardize, high accuracy and precision enables safety and efficacy in CAR T-cell therapy production.

Vector Copy Number Quantification

Accurate vector copy number (VCN) quantification is important for assessing the potency and safety of CAR T cells. High VCN is desirable for T cell efficacy, but it also carries an increased risk of oncogenesis. Therefore, accurate and precise measurements must be used to ensure the vector copy number stays within a safe and effective range.

Vector copy number (VCN) quantification of CAR T cells

Traditional DNA quantification methods, such as real-time PCR, lack the sensitivity and resolution needed to measure vector copy number with the accuracy and precision required for CAR T-cell therapy manufacturing. An alternative method, Droplet Digital PCR (ddPCR) technology, solves this problem.

The precision of ddPCR enables detection of as little as one CAR transgene copy per cell, providing evidence that the cell successfully took up the gene. Bio-Rad’s QX ONE and QX200 Droplet Digital PCR Systems offer unrivaled accuracy and precision for robust assessment of vector copy number using lentiviral or retroviral vectors across all stages of CAR-T development and manufacturing.

Bio-Rad’s Droplet Digital PCR (ddPCR) Systems, including QX ONE and QX200 Droplet Digital PCR Systems, support safe and effective CAR T-cell therapy manufacturing, enabling biopharmaceutical companies to offer patients hope in treating their cancer.​

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Quality Control (QC) in CAR T-Cell Production

Bio-Rad instruments and software meet Good Manufacturing Practice (GMP) regulations and QC environments and comply with the U.S. FDA’s 21 Code of Federal Regulations (CFR) Part 11 regulations.

Our compliance with International Organization for Standardization (ISO) extends beyond ISO 9001 to ISO 13485 and includes stringent documentation requirements and product-specific demands.

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Detect Contaminants in CAR T-Cell Therapies

Mycoplasma is a genus of small, antibiotic-resistant bacteria that could be present in 30% of cell lines. Due to their small size (2–3 µm across), they are difficult to detect, and if not removed promptly, they can infect patients receiving cell-based gene therapies. Mycoplasma pneumoniae, in particular, causes 2 million cases of pneumonia annually, which can be difficult to fight for patients undergoing CAR T-cell therapy.

Use our ddPCR tools for swift quality control during the CAR T-cell therapy manufacturing process. Robustly detect mycoplasma presence and absence with absolute quantification, which is essential to address such outbreaks in cell lines as soon as they occur. Leverage the Vericheck ddPCR Mycoplasma Detection Kit to test for 112 species of Mycoplasma contaminants in cell cultures, including Mycoplasma pneumoniae.