Plasmid Manufacturing

VectorBuilder can fulfill the full range of plasmid design, cloning, and manufacturing needs throughout the genetic medicine drug development pipeline. Building on our revolutionary vector design platform and extensive vector cloning and plasmid production experience, we can provide optimal vector designs tailored to a wide range of clinical needs and ensure production of high-quality, GMP-compliant plasmids.

GMP-grade plasmids can also be manufactured from our proprietary MiniVec™ backbone, which supports antibiotic-free and supplement-free selection, providing remarkable efficacy, safety, and manufacturability for cell and gene therapies.

Highlights

Experts in Vectorology Our team has extensive experience in designing and cloning complex and challenging vectors.

Scalable Solutions Versatile platform to support your production needs, from research to commercial purposes.

Highest Quality and Consistency State-of-the-art GMP facilities and equipment providing the highest purity and consistency.

Grades of Plasmid DNA Offered

We offer several grades of plasmid DNA manufacturing that cover different downstream needs including drug discovery research, preclinical studies, clinical trials, and commercialization.

R&D

Preclinical

Clinical

Commercial

Research-grade

GMP-like

GMP-grade

Suitable for basic research and drug discovery studies
Produced under standard laboratory conditions with stringent QC

Suitable for preclinical studies (e.g. animal testing of drug safety and metabolism)
Produced in PAS or GMP facilities in a manner that adopts key features of GMP guidelines
Can be produced under antibiotic-free and animal component-free conditions

Suitable for preclinical studies, clinical studies, and commercialization
Produced in our certified GMP suite with strict adherence to GMP guidelines
Includes comprehensive QC assays and batch release report

Comparison of different grades of plasmid DNA

	Research-grade	GMP-like	GMP-grade
Applications	Basic research, drug discovery, preclinical studies	Preclinical studies such as animal testing of drug safety and metabolism	Preclinical studies, clinical studies, and commercialization
Production scales	10 ug to several 100 mg	10 mg to 1 g per batch	10 mg to 5 g per batch
Turnaround	1-8 days	1-3 months	A few months to half a year
Quality system	ISO9001	ISO9001 while adopting key features of GMP system	ICH quality guidelines for GMP manufacturing
Production facility	In parallel production in shared laboratory space	Production in segregated suites	Production in certified GMP suites
Document control and traceability	No	Yes	Full traceability
QC and release	Concentration, OD260/280, RE digestion	Depending on individual project needs	Full panel QC assays, analytical development per individual project needs
Aseptic fill/finish	N/A	Available upon request	Yes
Storage of retention sample	Available upon request	Available upon request	Yes
Document deliverable	COA upon request	1. COA 2. Manufacturing summary 3. TSE/BSE statement upon request	1. COA 2. TSE/BSE statement 3. CTD documents 4. Others (BMR, etc.) upon request

Workflow for GMP Production of Plasmid DNA

VectorBuilder strives to deliver products of the highest quality on time. Below is a typical production workflow of GMP plasmid manufacturing:

Vector
Characterization

Process
Development

Cell
Banking

Plasmid
Production

QC & Release

1 week

1 month

1.5 months

3 weeks

RE digestion
Sequencing

Fermentation
optimization
Purification and
polishing optimization
Scale up
Analytical development
Stability studies

Segregated suite
(GMP-like)
GMP suite
(GMP-grade)

General/physical
properties
Identity
Purity
Safety

Platform Technologies

We offer high-quality and rapid GMP-grade manufacturing of plasmids, ideal for preclinical and clinical applications, with flexible scales ranging from
10 mg to 5 g per batch. The general manufacturing process is shown below:

Working cell bank
recovery and culture

Fermentation

Harvest and
alkaline lysis

Clarification and
concentration
(Depth filtration, TFF)

Purification
(Chromatography)

Formulation
(TFF, sterile
filtration, fill/finish)

QC and release

For more information on our manufacturing platform and/or GMP capabilities, contact the VectorBuilder service team.

Talk to Our Experts

Analytical Methods

Quality control assays

The table below summarizes the default QC assays (marked with ✓) for the release of GMP-like and GMP-grade plasmids. Optional QC assays are performed depending on individual project needs.

Attribute		QC Assay	GMP-Like	GMP-Grade
General/Physical Properties	Appearance	Visual inspection	✓	✓
	Concentration	Nanodrop	✓	✓
	pH	pH meter	✓	✓
	Extractable volume	Direct measurement	Optional	✓
	Osmolality	Osmometer	Optional	Optional
Identity	Plasmid size	Restriction digestion	✓	✓
	Full-length plasmid sequence	Sanger sequencing	✓	✓
		NGS	Optional	Optional
		Third-generation sequencing	Optional	Optional
Purity	OD260/280	Nanodrop	✓	✓
	Supercoiled plasmid ratio	Agarose gel electrophoresis	✓	✓
	Supercoiled plasmid ratio	HPLC	Optional	Optional
	Residual protein	Micro BCA	✓	✓
	Residual protein	ELISA	Optional	Optional
	Host E. coli RNA	Fluorometric quantification	✓	✓
	Host E. coli DNA	qPCR	✓	✓
	Residual antibiotic	ELISA	Optional	Optional
Safety	Sterility	Direct inoculation	Optional	Optional
	Sterility	Membrane filtration sterility test	✓	✓
	Endotoxin	Kinetic chromogenic assay (KCA)	✓	✓
Documentation	-	-	COA Manufacturing summary TSE/BSE statement upon request	COA TSE/BSE certificate CTD documents Others (BMR, etc.) upon request

Additional QC services not listed above may be provided upon request. Please contact our service team for more details.

Talk to Our Experts

Stability studies

Drug stability studies are performed following ICH guidelines. Forced degradation studies are performed to evaluate the influence of light, temperature, pH, etc., on the quality attributes of the plasmid DNA.

Our Facilities

VectorBuilder currently has about 100,000 ft² of modern GMP-compliant facilities with advanced designs and state-of-the-art equipment meeting GMP regulations of US, EU, Japan, China, and PIC/S. Our facilities comply with ICH guidelines and are suitable for GMP production for Phase I/II/III clinical trials.

Process & Analytical
Development Suites
GMP Manufacturing
Suites
Fill/finish Suites
QC Laboratories
GMP Warehouse

We have multiple GMP suites totaling 8,400 ft² for PD/pilot runs. All BSL-2 certified areas are set up with Grade A BSC in Grade C environment.

Our suites are designed for manufacturing plasmid, viral vector, and cell lines at various scales. Each suite is equipped with independent airflow. Our suites contain Grade A BSC in Grade B/C environment and are BSL-2 certified.