GMP CAR-T Plasmid DNA Manufacturing 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.

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.

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)

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

Q1: What types of plasmid DNA do you produce?

A1: 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.

Q2: How do you handle regulatory compliance?

A2: 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.