Yaohai Bio-Pharma has been involved in the Plasmid DNA (pDNA) quality control (QC) and batch release for different uses, e.g., naked plasmid, DNA vaccines, and pDNA as raw materials for virus-vectored therapy or mRNA.
We design QC Testing for appearance, identification, activity, purity, and impurities, following ICH Quality guidelines, relevant Pharmacopoeia (EU and US monographs), regulatory guidelines (ICH, FDA, and EMA), and GMP/GLP practices.
Service Details
| Category |
Quality Attributes |
Analytical Techniques |
| Raw materials, excipients |
All or Critical parameters of raw materials and excipients |
By validated analytical techniques (third party). |
| Packaging materials |
Thorough testing |
By validated analytical techniques (third party). |
| Physicochemical property |
Appearance, visible foreign material |
Visual |
| Insoluble particles |
Light obscuration |
| Particle diameter |
Zeta potential |
| pH |
Potential |
| Total organic carbon (TOC) |
Ultraviolet (UV) |
| Electrical conductivity |
Electrode |
| Osmolality |
Freezing point titration |
| Moisture content |
Titration |
| Loss on drying |
Atmospheric pressure, Vacuum drying |
| Residue on ignition |
Ignition |
| Deliverable volume |
Volumetric, gravimetric |
| Biochemical property |
DNA concentration |
UV |
| Identity |
Target gene sequencing |
Sequence alignment (third party) |
| Whole plasmid sequencing |
| Whole genome sequencing |
| Restriction enzymes digestion |
Agarose Gel Electrophoresis (AGE) |
| Product-related impurities |
Superhelix plasmid purity or linear plasmid purity |
AGE, High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis (CE) |
| Process-related impurities |
Residual endotoxin |
Gel method, chromogenic method |
| Host cell protein, HCP |
Enzyme-linked Immunosorbent Assay (ELISA) |
| Host cell DNA -HCD |
Quantitative Polymerase Chain Reaction (qPCR) |
| Host RNA |
Real-Time Quantitative Polymerase Chain Reaction (RT-qPCR) |
| Residual antibiotic |
ELISA |
| Bioburden |
Bioburden |
Plate counting, membrane filtration |
| Sterility |
Direct inoculation, membrane filtration |
| Stability studies |
Accelerated stability |
High-temperature, Photostability, Repeated freeze-thaw test |
| Long-term stability |
NA |
Our Experiences
Yaohai Bio-pharma has experience working with many classes of large molecules including but not limited to:
Naked plasmid for gene therapy, e.g., Vascular Endothelial Growth Factor (VEGF), Hepatocyte Growth Factor (HGF), Stromal Cell-derived Factor 1 (SDF-1).
DNA vaccine for infectious disease prevention or cancer therapy.
Plasmid DNA as materials for Adeno-Associated Virus (AAV) or mRNA production.
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