The Role of PCR in Cell and Gene Therapies


In the rapidly advancing field of cell and gene therapy, understanding the behavior of viral and non-viral vectors is crucial to drug development.

Analytical and bioanalytical assays play a vital role in characterizing these vectors. One key tool in this work is Polymerase Chain Reaction (PCR) technology. This post explores the applications of PCR in cell and gene therapies, focusing on its role in biodistribution, shedding, pharmacodynamic, and pharmacokinetic studies, and the essential services offered by TATAA Biocenter to support this complex work.

Cell and Gene Therapy Vectors and the Role of PCR

When it comes to cell and gene therapies, the type of vector employed makes a significant difference. These vectors are used to deliver genetic material into target cells for therapeutic purposes. Viral vectors, such as adeno-associated viruses and lentiviruses, as well as non-viral vectors like liquid nanoparticles (LNPs) each come with their own unique set of advantages and challenges. Critical to their successful application are biodistribution studies – understanding how and where these vectors spread in the body – and shedding studies, which investigate how the vectors are eliminated.

Moreover, pharmacodynamic and pharmacokinetic studies help us understand the effects of gene therapy and how the body processes these vectors, respectively. Here, PCR has become an essential application for drug development. With its capacity to amplify minute amounts of DNA, PCR allows scientists to detect and quantify viral vectors in biological samples, providing essential data for these studies.

Digital and quantitative PCR Services at TATAA Biocenter

TATAA Biocenter offers dPCR and qPCR services specifically tailored to support research in this field. With our extensive 20+ years of PCR expertise and a diverse range of digital and quantitative PCR platforms, we are well-equipped to assist pharmaceutical and biotech companies in navigating the complex landscape of cell and gene therapy research with exceptional ease and precision.

TATAA’s PCR services encompass a wide spectrum of customer requirements, ensuring the identification of the most suitable PCR platform for each unique need. We offer end-to-end PCR solutions from nucleic acid extraction, assay design, optimization and validation to data analysis and interpretation.

Understanding qPCR and dPCR Technology

Understanding the principles and intricacies of quantitative PCR and its more advanced form, digital PCR (dPCR), is crucial for any biopharma company involved in cell and gene therapies. These analytical techniques provide the sensitivity and specificity required to detect and quantify viral vectors or therapeutic genes in complex biological samples.

Sensitivity refers to the ability of the PCR assay to detect low quantities of the target sequence, even amidst large quantities of non-target nucleic acids. This feature is particularly important in biodistribution studies, where the target might be present in very low quantities in certain tissues.

Specificity, on the other hand, refers to the ability of the PCR assay to exclusively amplify the target sequence without amplifying non-target sequences. This is crucial in shedding studies, where it’s essential to differentiate between the target nucleic acid and the host DNA or RNA, or other potential contaminants.


Whether it’s biodistribution, shedding, pharmacodynamic, or pharmacokinetic studies, PCR has shown to be an important tool in cell and gene therapy research. PCR enables precise and sensitive amplification, detection, and quantification of specific sequences, making it an indispensable tool for various aspects of cell and gene therapy research, from basic research to diagnostic applications and therapeutic monitoring.

As a CRO for molecular analysis, TATAA Biocenter is in a unique position to offer a fully comprehensive PCR service that supports cell and gene therapy development.

Want to know more about our molecular analysis services and PCR in CGT?





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