Cell Bank Preparation for Gene Therapy

Gene therapy is a method of using genetic engineering technology to treat or prevent diseases, in which cell bank preparation is an important part of ensuring the safety and effectiveness of gene therapy products. Cell bank preparation requires comprehensive testing of cell lines or strains for biologics such as gene therapy products to obtain approval from the relevant regulatory authorities.

With the rapid development of gene therapy research, the safety evaluation of gene therapy formulations is receiving more and more attention. CD Formulation provides a wide range of technical services including cell identification, sterility check, mycoplasma detection, and internal and external source viral factor contamination detection following the relevant regulations, which are used to support cell bank testing in gene therapy.

Importance of Cell Bank Preparation for Gene Therapy

• Ensure the purity of the cell bank. Ensures that the cells in the cell bank remain consistent and free from contamination by other cell lines or microorganisms. This is critical to the quality and safety of subsequent gene therapy products.
• Ensure patient safety. Detects possible microbial contamination and viral contaminants, including foreign and specific viruses, in cell banks to prevent therapeutic risks due to cell bank contamination and protect patient safety.
• Supporting cell bank stability. Genetic stability testing ensures that cells remain stable during long-term storage and passaging, avoiding genetic variation that could affect the efficacy and safety of gene therapy.
• Meet regulatory requirements. Cell bank testing meets the requirements of regulatory agencies and helps gene therapy product declarations and marketing approvals.

Our Services for Cell Bank Preparation for Gene Therapy

Cell bank characterization

• Identification. Use genotyping methods such as multilocus sequence analysis (MLS), DNA fingerprinting, and chromosomal karyotyping to ensure the correct cell line.
• Microbial contamination detection. Evaluate cell banks for microbial contamination, including Mycoplasma, Spiroplasma, etc.
• Exogenous virus detection. For possible exogenous viral contamination, testing is performed using PCR methods and techniques such as transmission electron microscopy (TEM).
• Specific virus detection. Depending on the culture history of the cell line, broad-spectrum virus detection methods are selected, including in vitro and in vivo tests to ensure the absence of viral contaminants; specific viruses may include bovine viruses, porcine viruses, rodent viruses, etc.
• Genetic stability assays. The genetic stability of cells under long-term storage conditions is assessed by genome and transcriptome sequencing, restriction mapping, and copy number variation analysis.

Cell bank preparation

We perform mammalian and insect cGMP master and working cell bank preparation and prepare non-production and research cell banks.

Cell bank storage

In addition to cryogenic freezers dedicated to cell bank production and short-term storage, we have specific instrumentation for long-term cell bank storage, and our cryogenic freezers have the following features.

• The instrumentation is housed in a secure area.
• Continuous monitoring by our proven monitoring system.
• Equipped with redundant controls, 24 hour monitoring and backup generators.
• Supported by a laboratory-specific information management system.

Our Equipment and Instruments for Cell Bank Preparation for Gene Therapy

Highlights of Our Cell Bank Preparation for Gene Therapy

• We offer customized solutions that can be tailored to meet our clients' project needs.
• We have quality program management capabilities to solve customer cycle pain points faster with the same technology.
• We are constantly developing fast-track alternative technologies to meet customer needs while complying with regulatory requirements.
• We provide cell bank testing technology services that are leading in the industry.

Published Data

CD Formulation Based on years of service experience and an advanced technology platform, we offer a full range of cell bank preparation services in gene therapy. If you are interested in us, please feel free to contact us.