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cGMP CAR-T AAV Production Service

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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

Creative Biolabs offers comprehensive cGMP AAV production services tailored specifically for CAR-T therapies, ensuring compliance with the highest regulatory standards. Our facility is equipped with advanced technologies for scalable production, from cell line development to purification and quality control.

CGMP AAV

CGMP AAV refers to "Current Good Manufacturing Practice" (CGMP) standards applied to the production of adeno-associated viruses (AAV) used in gene therapy and other biomedical applications.

  • Current Good Manufacturing Practice (CGMP): These are regulations established to ensure that products are consistently produced and controlled according to quality standards. Compliance with CGMP is essential for the safety and efficacy of pharmaceuticals, biologics, and medical devices.
  • Adeno-Associated Virus (AAV): AAV is a small virus that is not known to cause disease in humans and is commonly used as a vector for gene therapy. It is capable of delivering genetic material into cells, which makes it a valuable tool for treating genetic disorders, certain types of cancer, and other conditions.

Importance of CGMP in AAV Production:

  • Ensures that the AAV produced is safe for therapeutic use in humans.
  • Establishes rigorous quality control measures to minimize variability and contamination.
  • Regulatory Approval: Compliance with CGMP is often a requirement for regulatory approval before clinical trials or commercialization of products.
  • Scalability: CGMP processes can facilitate the scale-up of AAV production to meet clinical and commercial demands.

Our Service

Our cGMP AAV production service for CAR-T therapies offers a robust and compliant solution for the manufacture of high-quality adeno-associated virus vectors. We utilize state-of-the-art technology and stringent quality control measures to ensure the safety and efficacy of the viral vectors. Our process encompasses everything from cell line development and transfection to purification and comprehensive testing, adhering to the highest regulatory standards. Emphasizing both scalability and customization, we collaborate closely with our clients to tailor our services to their unique requirements. Our support spans the entire process, guiding them from early-stage research through to clinical application, ensuring that their specific project goals are met at every step of development.

Fig.1 Advantages. (Creative Biolabs Original)

  • Selection of Host Cells: Typically, HEK293 or other suitable cell lines are used for AAV production.
  • Transfection: The process involves co-transfecting cells with a combination of plasmids, including those carrying the AAV genome, necessary helper genes, and the gene of interest, such as the CAR construct. This multi-plasmid approach is essential for efficient AAV production, enabling the delivery and expression of the desired genetic material within the target cells.
  • Transfection Optimization: Conditions such as transfection reagents, ratios of plasmids, and incubation times are optimized for maximum yield.
  • Incubation: Transfected cells are cultured in a controlled environment to allow AAV to replicate.
  • Cell Lysis: After a certain period, cells are harvested, and the viral particles are released by lysis.
  • Clarification: The lysate is clarified through centrifugation or filtration to remove cell debris.
  • Chromatography: Purification of AAV vectors is achieved through advanced techniques such as affinity chromatography and ion exchange chromatography. These methods are essential for removing impurities, including host cell proteins and other contaminants, ensuring that the final product is of the highest purity and quality.
  • Ultrafiltration: Further concentration and buffer exchange are done to prepare the virus for formulation.
  • Buffer Preparation: The purified AAV is formulated into a suitable buffer for storage and administration.
  • Stabilization: Additives may be included to stabilize the virus during storage.
  • Testing: Each batch undergoes rigorous testing, including:
    Potency Assays: Assessing the ability of the AAV to transduce target cells.
    Purity Testing: Ensuring there are no contaminants or residual plasmids.
    Identity Confirmation: Verifying the viral genome and CAR expression.
    Stability Studies: Testing the stability of the formulation over time.
  • Storage: AAV vectors are usually preserved at low temperatures to ensure long-term stability and maintain their potency.
  • Documentation: Keep comprehensive records throughout the entire production process, including batch production logs, quality control data, and standard operating procedures (SOPs). Thorough documentation is crucial for ensuring traceability, compliance with regulatory standards, and maintaining consistency in manufacturing processes.

Contact Us

Our dedicated team is here to assist you with your cGMP AAV production requirements at every stage of the process. If you need more information, a personalized quote, or advice on how our services can support your project objectives, don't hesitate to contact us via phone or email. You can also complete the contact form on our website, and one of our specialists will get back to you swiftly. Let us collaborate with you to expedite your research and make a significant impact in the field of gene therapy!

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