Cell & Gene Therapy Bioanalytics

The forefront of modern medicine, offering transformative potential for treating genetic disorders, cancer, and other diseases. At WaveCyte BioLabs, we provide specialized bioanalytical solutions tailored to the unique requirements of these advanced therapies, ensuring precise, reliable data to support their development and regulatory approval.

Our Cell & Gene Therapy Bioanalytical Services

CAR-T Cell Functional Testing: Evaluate CAR-T cell functionality through assays measuring cytokine release, cytotoxicity, and target-specific activation, ensuring therapeutic potency and efficacy.

Potency Assays: Develop and validate potency assays to measure therapeutic efficacy and functionality in compliance with regulatory standards.

Vector Characterization: Comprehensive analysis of viral and non-viral vectors, including titer, purity, and transduction efficiency.

Gene Expression Analysis: Quantitative and qualitative assessment of transgene expression using techniques such as qPCR, RT-PCR, and next-generation sequencing (NGS).

Immunogenicity Testing: Assess immune responses to cell and gene therapies, including anti-drug antibodies (ADAs) and cytokine release.

Residual Impurity Testing: Detection and quantification of impurities such as host cell DNA, proteins, and other process-related contaminants.

What Is Cell Therapy

Cell therapy involves the transfer of live, functional cells "living drugs" into a patient to repair or replace damaged or dysfunctional tissues. These cells may come from the patient (autologous) or a donor (allogeneic). Key examples include:

• CAR-T Cell Therapy: Immune cells (T cells) are engineered to target and destroy cancer cells.

• Stem Cell Therapy: Stem cells are used to regenerate damaged tissues or treat conditions like blood disorders or spinal cord injuries.

Combining advanced technologies with industry expertise to deliver high-quality bioanalytical data for cell and gene therapy development. From vector characterization to CAR-T functional testing, our services are designed to ensure the safety and efficacy of your therapies while meeting regulatory standards. We prioritize compliance and data integrity, tackling the unique challenges posed by these advanced modalities.

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Gene therapy involves modifying or replacing defective or missing genes in a patient’s cells to correct genetic disorders. This is often achieved through the use of viral or non-viral vectors to deliver the genetic material into cells. Examples include:

• Gene Addition: Introducing a healthy copy of a gene to replace a faulty one (e.g., for diseases like cystic fibrosis or sickle cell anemia).

• Gene Editing: Using technologies like CRISPR-Cas9 to directly modify DNA at precise locations.

What Is Gene Therapy