Plasmid DNA Manufacturing Services


Plasmids are small double-stranded units of DNA, usually in circular or linear form. They are found separately from the bacterial chromosome and can multiply on one’s own.

Their ease of manipulation, ability to make identical copies of themselves, as well as their long-term stability, have made them essential tools in genetic engineering and biotechnology applications. One of their vital roles is as a delivery vehicle to introduce new genetic material into bacteria.

Esco Aster offers CDMO services to process develop and manufacture various grades of plasmid DNA used for early-stage research to preclinical, clinical phase trials. Our process development services support the product development regardless of its current development status, whether the product is in early-stage development or ready to launch. We maintain GMP standards from the starting material to the final drug products in our Plasmid DNA production facility.

The advantage of choosing a GMP-grade plasmid from the start lies in the smooth regulatory transition to the next steps. You can count on our advanced, end-to-end single-use technology, state-of-the-art facility and most importantly, skilled and passionate personnel to find the most suitable path and guide you through your journey from gene to the final vialed product.

Main Applications

Our Plasmid DNA Manufacturing Services are employed in the following areas:

Viral Vector Production
Gene Editing
mRNA Production
DNA Vaccines
Cell and Gene Therapy
Our Production Process

Our Production Process

Esco Aster’s state-of-art facility has an end-to-end, single-use bioprocessing capacity to manufacture plasmid of the highest grade of purity following the GMP guidelines FDA 21 CRF Part 820. This facility includes ISO standards cleanrooms, bioprocessing equipment of cutting edge technology coupled with our experts, and in-house product release testing capabilities. Moreover, the use of single-use technology eliminates the possibility of cross-contamination between products and batches. We maintain highest standard of cleanliness of the facility by following EU GMP annex 1 guideline for environmental monitoring.

Esco Aster has a facility to perform microbial fermentation, cell harvesting by continuous centrifugation, cell lysis by alkalization, clarification in tangential flow filtration, purification and polishing in liquid chromatography. All the equipment and core technologies are selected and validated for single-use operation. Esco Aster has branded isolator system for bulk filling of the final product into sterile packaging.

Laboratory Testing Regulations

Esco Aster provides three (3) different grades of plasmids following the intended applications to fit the requirement from clients. The variety of plasmid comes with different level of preparation and documentation as follows:

Laboratory Testings Solutions
Grade Description Capacity Lot Size (g)
GLP Grade
  • Plasmid is produced in GLP laboratory
  • Single-use bioreactor to eliminate possibility of contamination.
  • CoA will be issued as per quality checks
  • Documentation as per GLP lab regulation
  • Batch documentation are reviewed and signed
5-30L < 5
GMP (HQ) Grade (FDA 820/ISO 13485)
  • Plasmid is manufactured in a cGMP qualified area
  • E. coli master and working cell bank generation
  • Process equipment are validated
  • Quality assays are performed in controlled environment
  • Manufacturing summary report
  • Plasmids are released with a CoA
  • Batch documentation are reviewed and Signed by QA (critical steps only)
30-100L 5-10
cGMP Grade
  • Plasmid is manufactured following all GMP manufacturing guidelines
  • Same process as GMP grade and performed with GMP compliance
  • Expected QA oversight of equipment, facilities, personnel and pDNA process
30-100L 5-10
project managed by Esco Aster outsourced to qualified vendor

Quality Control Assay

Esco Aster offers following quality checks on plasmid of different grades based on your applications and requirements

Assay Method AQL GLP Grade GMP Grade
(FDA 820 / ISO 13485)
cGMP Grade
Appearance Visual Inspection Clear, Particle-free
Concentration UV Spectrophotometry Product Specific
Purity UV Spectrophotometry (Abs260/Abs280) 1.8-2.0
Plasmid Identity Gel Electrophoresis Confirm
DNA Homogeneity Gel Electrophoresis and Gel Densitometry  > 90% supercoiled
Restriction Analysis  Restriction Digest and Gel Electrophoresis Coherent fragments with the plasmid restriction map
Plasmid Sequence Gene Sequencing Confirm
Residual Host Cell Protein ELISA <1.0% Optional
Micro BCA <1.0%
Residual Host Genomic DNA Quantitative PCR <0.1%
Residual Host RNA HPLC < 0.1% by HPLC Optional
SYBR Gold Stained Agarose Gel Electrophoresis Undetectable (Gel)
Endotoxin Kinetic Chromogenic LAL < 10 EU/mg
Mycoplasma Contamination Quantitative PCR Negative
Bioburden Testing for Total Aerobes, Anaerobes, Spore Formers and Fungi Not Detected
Residual Kanamycin ELISA Product Specific
pH pH meter Product Specific
Conductivity Conductivity meter Product Specific

Project Management

An approximate project management timeline in producing plasmid DNA of different grades in Esco Aster furnished with state of the art, end-to-end, single-use equipment.

Major Project Milestones GLP Grade GMP Grade
(FDA 820/ISO 13485)
cGMP Grade
Kick-off Project
(upon receipt of order)
< 2 weeks < 3 weeks < 3 weeks
Manufacturing Production Period 
(starting from strain transformation)
  • Seed train
  • Fermentation
  • Cell lysis
  • Purification
  • Quality control
2 - 3 weeks 3 - 4 weeks 5 - 6 weeks
Progress Update Weekly Weekly Weekly
Dedicated Project Manager Yes Yes Yes
Certificated of Analysis (CoA)
Manufacturing Summary Report
Manufacturing Batch Records 
cGMP Compliance Statement

Some services are still being built up and ready only by Y2024. Please inquire for further information and updates through