GMP CAR-T Virus Manufacturing Service

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Welcome to Creative Biolabs' Good Manufacturing Practices (GMP) grade virus manufacturing services designed specifically for CAR-T therapies. Our state-of-the-art facility is fully compliant with GMP, ensuring that we produce high-quality viral vectors that meet regulatory standards. We specialize in the production of lentiviruses, adenoviruses, and other viral vectors essential for the development of cutting-edge cell therapies. With a dedicated team of experts and a commitment to innovation, we provide tailored solutions that streamline the manufacturing process and support your research trials, enabling you to advance your CAR-T therapies with confidence.

What is GMP Grade Virus

GMP Grade Virus refers to viral preparations that are produced according to Good Manufacturing Practices (GMP). These practices ensure that biological products, including viruses, are consistently produced and controlled in a quality manner suitable for their intended use, particularly in clinical trials and therapeutic applications.

GMP-grade viruses are essential for various applications, including:

Gene Therapy
Vaccine Production
Oncolytic Viruses

GMP standards cover various aspects of production, including the quality of starting materials, the production environment, monitoring and testing for contaminants, documentation, and traceability. Meeting these standards helps to ensure that the final product is safe for use in humans

Our Service

Creative Biolabs is excited to offer our specialized GMP Grade Virus Manufacturing service for CAR-T therapies. Our state-of-the-art facility is equipped to produce high-quality viral vectors under stringent GMP regulations, ensuring that every batch meets the rigorous standards required for clinical applications. Our team of experienced scientists and engineers is dedicated to optimizing the production process, providing you with reliable and scalable solutions tailored to meet your specific project needs. By partnering with us, you can be confident in the quality and efficacy of your CAR-T products, facilitating advancements in personalized immunotherapies.

Fig.1 Advantages. (Creative Biolabs Original)

Manufacturing Process

The production of GMP-grade virus vectors used in CAR T therapy involves several critical steps to ensure safety, quality, and efficacy. Firstly, the process begins with the selection of suitable viral vectors, often derived from lentiviruses or retroviruses, followed by the design of the CAR construct. Once the vector is engineered, stringent quality control measures are employed during the cell culture phase, where producer cell lines are maintained under controlled conditions to ensure consistent yields of viral particles. Following this, purification processes, such as ultracentrifugation or chromatography, are implemented to isolate the viral particles from cellular debris and other contaminants. Each batch undergoes rigorous testing for potency, identity, and sterility to meet regulatory standards.

Fig.2 Process. (Creative Biolabs Original)

QC & Analytical Capabilities

We provide a comprehensive quality control framework to ensure viral vectors are safe, effective, and stable. The following table summarizes the main testing categories and typical release criteria:

Test Category	Technology	Typical Release Criteria	Notes
Titer Measurement	Titer Measurement	Lentivirus: ≥1×10⁹ TU/mL Retrovirus: ≥1×10⁹ TU/mL AAV: ≥1×10¹³ GC/mL	Ensures sufficient infectious units for intended use
Replication Competence	RCL / RCV assays	Negative (limit of detection ≤1 TU/mL)	Confirms absence of replication-competent virus
Integration Site Analysis	LAM-PCR / NGS	Random distribution without abnormal hotspots	Evaluates insertional safety
Residual Host Proteins	ELISA / SDS-PAGE	≤50 ng/mL	Reduces potential immunogenicity
Residual Host DNA	qPCR	≤10 ng/dose	Minimizes the risk of unwanted DNA
Endotoxin	LAL assay	≤5 EU/mL	Ensures product safety for injection
Purity / Impurity Analysis	SDS-PAGE / HPLC	≥90% target component	Ensures batch consistency and purity
Stability Studies	Storage at -80°C / -20°C / 4°C, accelerated conditions	Retains ≥80% initial titer over 3 months	Supports long-term storage and transport

Key Advantages

Customizable Scale Manufacturing: One-stop viral vector production service from laboratory scale optimization, pilot scale-up to large-scale commercial supply.
Integrated Process Development: Efficient upstream (cell culture optimization, transfection/infection kinetics) and downstream (chromatography) process development to maximize vector yield and purity
Guaranteed Starting Material Quality: Documentation quality and procedures of vector plasmid origin and producer cell line stability are assessed and approved by a qualified quality assurance service.

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Frequently Asked Questions

What production scale and titer can you achieve?

We offer flexible scales from early-phase to Phase II/III. Titer depends on your construct, but our platform delivers highly concentrated vectors for efficient CAR-T transduction. Specific goals can be discussed in consultation.

How is RCV risk controlled?

Through RCV-free producer cells, controlled GMP environments, and validated RCV release assays for every lot, ensuring maximum safety.

Can you use proprietary plasmids?

Yes, if produced under GMP-like or GMP standards with full documentation. We can also manufacture plasmids in-house for immediate compliance.

Do you support other delivery systems like AAV or mRNA?

Core expertise is Lentivirus and Adenovirus for CAR-T/TCR-T, but we also offer AAV and mRNA/LNP platforms. Contact us to discuss alternative vector needs.

Customer Reviews

Using Creative Biolabs' GMP CAR-T Virus Manufacturing Service in our research has significantly improved/facilitated the quality of our CMC documentation, making our IND submission process seamless and stress-free. La Do.

Using Creative Biolabs' GMP CAR-T Virus Manufacturing Service in our research has significantly improved / facilitated our final cell transduction rate, offering a vector that was demonstrably higher in infectious titer and lower in host cell DNA compared to our previous CRO's product. An Pl.

Contact Us

We are ready to help you with your GMP-grade virus manufacturing needs. For any inquiries, quotes, or to discuss your specific requirements, please feel free to contact us. You can reach us via email at info@creative-biolabs.com. Additionally, feel free to fill out our online contact form on our website, and we'll get back to you promptly. Let us partner with you in advancing your CAR-T therapies through high-quality viral vector production.

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