Plasmid Manufacturing Services

Overview

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 manufacture various grades of plasmid DNA for preclinical, clinical and commercial production. We maintain GMP standards from the starting material to the final drug products in our Plasmid DNA production process.

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 advance technology, state-of-the-art facility and most importantly, skilled and passionate personnel to find the most suitable path and to guide you through your journey from gene to 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.

The use of single-use technology eliminates the possibility of cross-contamination between products and batches. This facility includes ISO standards cleanrooms, bioprocessing equipment of cutting edge technology coupled with our experts, and in-house product release testing capabilities.

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