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CAR-T Plasmid Global CDMO Services

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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

In the rapidly advancing fields of gene therapy, cancer treatment, and other biotechnological applications, plasmid DNA is a cornerstone for further development. Creative Biolabs is committed to providing comprehensive global CDMO services for plasmids ranging from research-grade to GMP-grade plasmid DNA, ensuring that every stage of drug development and production is covered efficiently and meticulously.

Global CDMO Services for CART Plasmid

Creative Biolabs offers comprehensive Contract Development and Manufacturing Organization (CDMO) services for CART plasmids, which play a pivotal role in the transformative field of cell therapy. Our services span research-grade to GMP-grade production, tailored to meet an array of research, pre-clinical, clinical, and commercial needs.

Research Grade (RG) CAR-T Plasmid DNA Manufacturing

With our dedicated research-grade plasmid production, we deliver high-quality plasmid DNA suitable for basic research and early drug discovery processes. Utilizing stringent quality control (QC) measures, our research-grade plasmids are produced to support exploration and validation studies in the initial stages of CART development.

GMP-like CAR-T Plasmid Manufacturing

For pre-clinical studies, including animal testing of drug safety and metabolism, our GMP-like plasmid production adopts key features of Good Manufacturing Practices (GMP). This includes segregated production suites, document control, traceability, and optional antibiotic-free conditions, embodying a cost-effective mimic of full GMP processes.

GMP CAR-T Plasmid DNA Manufacturing

Our GMP plasmid DNA manufacturing service meets the highest quality standards, suitable for clinical and commercial applications. Produced in certified GMP suites, our plasmids adhere to rigorous quality assurance protocols encompassing a comprehensive array of in-process and release QC assays. Each batch comes with a detailed release report and certificate of analysis.

Service Content

Small-scale and Large-scale Production

Creative Biolabs excels at catering to diverse production needs. Our small-scale service line offers rapid production of plasmid DNA, ideal for the transfer and packaging of plasmids, as well as mRNA manufacturing starting materials. For larger needs, we provide scalable GMP-compliant production, with fermentation capacities.

Clinical and Commercial pDNA Manufacturing

We support the intricate needs of advanced therapies, including DNA adjuvants, vaccines, and viral vector manufacturing (AAV and LVV). Our expansive capabilities encompass both clinical and commercial pDNA products, produced under rigorous GMP conditions.

Non-viral DNA Vector Development

Our expertise extends to non-viral DNA vector engineering and manufacturing. Leveraging our robust production process, we achieve high-quality plasmid DNA suitable for therapeutic applications, including sequences with complex elements like ITRs, LTRs, and polyA tails.

Workflow

Vector Characterization

Detailed analysis and optimization of the plasmid vector.

Plasmid Production

Scalable fermentation and plasmid extraction.

Process Development and Cell Banking

Establishment of robust cultures and cell banks.

Quality Control and Release

Comprehensive QC assays and documentation.

Quality Control

At Creative Biolabs, we employ a stringent QC framework to ensure the highest quality of plasmid DNA. Key assays include:

Physical Properties

Assessment of appearance, concentration, pH, osmolality, and aggregation.

Identity Confirmation

Restriction enzyme digestion and sequencing.

Safety Testing

Sterility tests and endotoxin determination.

Stability

Long-term and stress condition stability studies per ICH guidelines.

Purity Assessment

OD260/280 ratios, supercoiled plasmid determination through agarose gel electrophoresis and HPLC, residual protein analysis, and host DNA/RNA quantification.

Features of Our Service

Fig.1 Features of our service. (Creative Biolabs Original)

Frequently Asked Questions

Q1: What are the typical applications of your plasmid DNA products?

A1: Our plasmid DNA products are utilized in a variety of applications, including basic research, drug discovery, preclinical testing, clinical trials, and commercial biomanufacturing processes for CGT therapies.

Q2: Can you accommodate custom plasmid DNA production requirements?

A2: Yes, our flexible manufacturing capabilities allow us to customize plasmid DNA production to meet specific project needs, including special fermentation conditions and customized QC testing.

By choosing Creative Biolabs for your plasmid DNA needs, you are partnering with a leader in genetic medicine manufacturing, equipped to deliver high-quality plasmid DNA tailored to your specific research, preclinical, and clinical requirements.