GMP-like CAR-T Plasmid Manufacturing Service

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Background Service Service Content Workflow Quality Control Quality Specifications Highlights FAQs

Introduction

Chimeric Antigen Receptor T-cell (CART) therapy represents a groundbreaking advancement in cancer immunotherapy. At the core of this therapeutic innovation lies the genetic engineering of T-cells using plasmid DNA vectors. The manufacturing of Good Manufacturing Practice (GMP)-like plasmid DNA is crucial to ensure the safety, efficacy, and regulatory compliance of these therapies. Creative Biolabs, with over two decades of industry experience, excels in providing superior GMP-like plasmid manufacturing services to support CART development.

GMP-like Plasmid Manufacturing for CART at Creative Biolabs

GMP-like plasmid DNA is designed for pre-clinical studies such as animal testing of drug safety and metabolism. This grade adopts key features of GMP guidelines, ensuring a production process with stringent document control and traceability. Creative Biolabs leverages an advanced, streamlined manufacturing process to produce high-quality plasmid DNA for CART applications. Our facility is equipped with state-of-the-art technologies and adheres to rigorous GMP-like standards to ensure that each batch of plasmid DNA meets stringent quality and safety criteria.

Service Content

Creative Biolabs provides a comprehensive spectrum of services to support every aspect of plasmid DNA manufacturing:

Fig.1 Service content. (Creative Biolabs Original)

Service Workflow

At Creative Biolabs, our GMP-like plasmid DNA manufacturing process operates within a robust, quality-focused framework that incorporates key GMP principles. This ensures high-purity, consistent plasmid outputs suitable for CAR-T research and preclinical use. Every production phase is meticulously engineered and verified to attain outstanding uniformity, traceability, and adherence to regulatory standards.

Workflow of GMP-like Plasmid Manufacturing for CART. (Creative Biolabs Original)

Contact our team for additional information and to discuss your project needs.

Our Quality Control

Our GMP-like plasmid manufacturing follows stringent quality assurance protocols to guarantee the safety and efficacy of the final product. Our quality control assays encompass a range of tests to ensure comprehensive quality assessment:

General and Physical Properties: Concentration, appearance, pH, and osmolality.
Identity and Purity: Restriction enzyme digestion, sequencing, supercoiled plasmid ratio, and residual host DNA.
Safety: Endotoxin levels, sterility tests, and bioburden testing.
Documentation and Traceability

We provide detailed documentation for each production batch, including Certificates of Analysis (CoA), batch records, and traceability reports. These documents ensure full transparency and compliance with regulatory requirements.

Quality Specifications

All GMP-like CAR-T plasmid DNA products from Creative Biolabs are manufactured under a controlled, validated process and released according to strict internal specifications. Each batch is accompanied by a detailed Certificate of Analysis (CoA) that confirms identity, purity, safety, and functionality.

The following table summarizes typical release specifications for our standard GMP-like plasmid DNA grade. Custom specifications and analytical parameters can be developed upon client request.

Category	Test Item	Acceptance Criteria	Analytical Method
General Characteristics	Appearance	Clear, colorless solution, no visible particles	Visual inspection
	Concentration	1.0–5.0 mg/mL	UV spectrophotometry at 260 nm
	OD₂₆₀/OD₂₈₀Ratio	1.8–2.0	UV spectrophotometry
	pH	7.0–7.5	pH meter
Identity	Restriction Enzyme Mapping	Pattern matches reference plasmid map	Agarose gel electrophoresis
Identity	Sequence Verification	100% identity with reference sequence	Sanger sequencing / NGS
Purity and Topology	Supercoiled DNA Fraction	≥ 90% (preferably ≥ 95%)	Agarose gel densitometry / HPLC
	Open Circular (OC) DNA	≤ 5%	Agarose gel analysis
	Linear DNA	≤ 2%	Agarose gel analysis
Residual Impurities	Residual Host Genomic DNA	≤ 1% of total nucleic acid	qPCR / PicoGreen assay
	Residual RNA (ROP)	≤ 1%	UV absorbance / Bioanalyzer
	Residual Host Proteins	≤ 0.1 µg/mg plasmid DNA	ELISA
	Residual Endotoxin	≤ 0.1 EU/µg DNA	LAL assay
	Residual Antibiotic	Not detected	HPLC
	Metal Ion Residues	≤ 10 ppm total metals	ICP-MS
Safety and Sterility	Bioburden	< 10 CFU/100 µL	Plate count
	Sterility	No growth observed	USP <71> sterility test
	Mycoplasma	Negative	PCR-based detection
Functional Quality	Transfection Efficiency	Comparable to the control plasmid	In vitro transfection assay
Functional Quality	Integrity	No degradation bands	Agarose gel electrophoresis
Stability / Storage	Stability (Real-Time)	≥ 12 months at −20 °C (validated)	Periodic QC testing
Stability / Storage	Stability (Accelerated)	1 month at +37 °C: ≥ 90% supercoiled DNA retained	Accelerated stability test

Benefits of Our GMP-like Plasmid Manufacturing Service

Creative Biolabs' GMP-like plasmid manufacturing service offers several unique advantages:

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

Frequently Asked Questions

How does GMP-like manufacturing differ from full GMP?

GMP-like manufacturing incorporates key GMP features such as document control and traceability but is designed to be a more cost-effective and faster alternative for pre-clinical studies. The quality attributes are comparable, but the scale and some production specifics might differ.

What are the endotoxin levels in GMP-like plasmid DNA?

Our GMP-like plasmid DNA has extremely low endotoxin levels, which is critical for maintaining high transfection efficiency and viability in cell lines.

By offering high-quality plasmids produced under meticulous conditions, we empower researchers and clinicians to advance in their efforts to develop innovative and life-saving treatments. Explore the full potential of our GMP-like plasmid manufacturing services and take your CART research and clinical applications to new heights.

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