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.
Our Plasmid DNA Manufacturing Services are employed in the following areas:
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.
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:
|Grade||Description||Capacity||Lot Size (g)|
|GMP (HQ) Grade (FDA 820/ISO 13485)||
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)
|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|
|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|
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)
(upon receipt of order)
|< 2 weeks||< 3 weeks||< 3 weeks|
Manufacturing Production Period
(starting from strain transformation)
|2 - 3 weeks||3 - 4 weeks||5 - 6 weeks|
|Dedicated Project Manager||Yes||Yes||Yes|
|Certificated of Analysis (CoA)|
|Manufacturing Summary Report|
|Manufacturing Batch Records|
|cGMP Compliance Statement|