CAR-T Global CDMO Services

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Global Services. (Creative Biolabs Authorized)

GMP CAR-T Plasmid DNA Manufacturing Service

Q: What types of plasmid DNA do you produce?

We produce several grades of plasmid DNA, including research-grade, GMP-like, and full GMP-grade plasmids, tailored to different stages of drug development and clinical trials.

Q: How do you handle regulatory compliance?

All our processes comply with strict guidelines, supported by thorough documentation and traceability to meet global regulatory requirements.

Online Inquiry

Background Service Service Content Workflow Quality Control Performance Indicators Our Capabilities Highlights FAQs

Introduction

Chimeric Antigen Receptor (CAR) T cell therapy represents a revolutionary advancement in the treatment of various malignancies, particularly B cell malignancies. The process involves the genetic engineering of patients' T cells to express CARs, enabling them to specifically target and eradicate cancer cells. The efficient production of high-quality, GMP-grade plasmid DNA is crucial for this therapy's success, serving as the backbone for CAR T cell manufacturing. Creative Biolabs has been at the forefront of this field for over two decades, offering unparalleled expertise in the development and production of GMP plasmid DNA designed for CAR T cell applications.

Our GMP Plasmid DNA Manufacturing for CAR T

Creative Biolabs provides comprehensive GMP plasmid DNA manufacturing services crucial for CAR T cell therapy. Our state-of-the-art facilities are equipped to handle the intricate processes involved in producing plasmid DNA that meets stringent global regulatory standards. By leveraging cutting-edge technologies, we ensure the highest levels of purity, potency, and safety in our products. We support the manufacturing process from early-stage development through to commercial-scale production, emphasizing compliance with strict guidelines.

Service Content

Our GMP plasmid DNA manufacturing services are tailored to support a wide range of applications within CAR T cell therapy, including:

Plasmid DNA Development and Production

We employ advanced techniques for the development and production of plasmid DNA, including high-density E. coli culture technology, to produce gram-scale quantities of GMP-grade plasmid DNA.

Plasmid DNA Development and Production

We develop and prepare MCBs of recombinant E. coli, ensuring the reliability and stability required for large-scale plasmid DNA production.

Scale-Up Capability

Our facilities can produce plasmid DNA in batch sizes ranging from 30 to 2200 liters, accommodating various needs from research-grade to full commercial-scale production.

Production Process

Our plasmid DNA production process follows a standardized, fully traceable procedure designed to ensure consistency, scalability, and conformity to global quality standards. Each stage is closely monitored via in-process checks and documented in accordance with GMP guidelines.

Workflow of HiCAR construction service. (Creative Biolabs Original)

Connect with our team to receive further information and review your project plan.

Quality Control Testing

Ensuring the integrity and safety of plasmid DNA is a top priority in our GMP manufacturing process. Our quality control protocol includes extensive in-process and release testing:

Fig.1 Quality control testing contents. (Creative Biolabs Original)

Key Performance Indicators

Our plasmid DNA manufacturing process is guided by defined performance metrics to ensure consistent quality, safety, and efficiency across every production batch. All parameters are monitored under strict in-process and release criteria to meet global quality expectations.

Parameter	Description	Typical Specification
Supercoiled DNA Content	Percentage of plasmid DNA in supercoiled conformation, a critical indicator of functional integrity.	≥ 85 %
Purity	Overall removal of host cell contaminants such as RNA, genomic DNA, and proteins.	≥ 95 % purity (HPLC or gel-based analysis)
Endotoxin Level	Measure of residual endotoxin content to ensure safety for downstream applications.	≤ 0.1 EU/µg DNA
Residual Host DNA	Trace level of chromosomal DNA from production host cells.	Below detection limit
Residual RNA/Protein	Verification of complete removal of host-derived biomolecules.	Below detection limit
Yield	DNA mass output per production batch, depending on plasmid size and fermentation scale.	Typically 5–10 mg/L to >100 mg/L
Batch-to-Batch Consistency	Reproducibility of product quality parameters across multiple runs.	RSD < 10 %

All performance data are supported by validated analytical methods and documented in the final CoA. These metrics reflect our commitment to reproducible, high-quality plasmid DNA suitable for use in a broad range of advanced biomanufacturing applications. Please contact our team for additional information and to discuss your project requirements.

Customer Reviews

"We'd struggled with batch variability from other suppliers until switching to Creative Biolabs. Their standardized workflow eliminated that - our last 4 runs had less than 2% variance in yield. When a raw material delay threatened our deadline, they sourced an alternative with full qualification data, keeping us on track. Technical expertise paired with real problem-solving - exactly what we need. Dr. K. P**.

"As a lab scaling from preclinical to Phase I, we needed a plasmid manufacturer that could grow with us. Creative Biolabs did exactly that: starting with 50 mg batches, they smoothly scaled to 500 mg without sacrificing quality. Their in-process endotoxin checks kept our downstream T-cell transduction rates steady, and their team proactively updated us on timeline shifts. Far more reliable than our previous supplier. Prof. M. T**.

Our Capabilities

Creative Biolabs brings extensive capabilities to the table, ensuring efficient and compliant GMP plasmid DNA production:

Advanced Bioprocessing Technologies

Utilizing state-of-the-art single-use bioreactor systems, we eliminate cross-contamination risks and optimize plasmid yield and purity.

End-to-End Manufacturing Solutions

From cell line creation, plasmid production, and purification to final product packaging, our integrated approach streamlines the manufacturing process, reducing turnaround times.

Robust Compliance and Documentation

Our processes adhere to GMP guidelines, with thorough documentation and traceability maintained throughout the production cycle. Certificates of Analysis (COAs) and comprehensive batch records are provided for each lot.

Benefits for You

Partnering with Creative Biolabs offers multiple benefits for your CAR T cell therapy program:

Fig.2 Features of our service. (Creative Biolabs Original)

Frequently Asked Questions

What types of plasmid DNA do you produce?

We produce several grades of plasmid DNA, including research-grade, GMP-like, and full GMP-grade plasmids, tailored to different stages of drug development and clinical trials.

How do you handle regulatory compliance?

All our processes comply with strict guidelines, supported by thorough documentation and traceability to meet global regulatory requirements.

Creative Biolabs is committed to advancing the field of CAR T cell therapy through the provision of high-quality, GMP-grade plasmid DNA. By ensuring the highest standards of production and quality control, we empower our clients to bring innovative therapies to market, improving patient outcomes worldwide.

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