Yaohai Bio-Pharma provides flexible and customized analytical solutions, including phase-appropriate analytical method development and validation.
Our team has significant expertise in analytics for all stages of the biologics development lifecycle, from early-stage protocols to late-stage quality control (QC) method optimization. Tests are designed in consideration of the relevant Pharmacopoeia (EU and US monographs), regulatory guidelines (ICH, FDA, and EMEA), and GMP/GLP practices.
Our team has significant expertise in the analytics for plasmid DNA as active pharmaceutical ingredient (API), e.g., naked plasmid, DNA vaccine, as well as raw materials for cell therapy and virus-vectored gene therapy.
Service Details
- Method Development and Optimization for in-process controls, release, and stability studies
- Analytical Method Qualification/Validation
- QC and Stability Studies of research batches
- Reference standard generation and characterization
- Technology transfer to QC
Method Development and Pre-validation:
| Quality Attributes |
Analytical Methods |
Delivery Time (Working Days) |
| Supercoiled Plasmid Percentage |
HPLC (High Performance Liquid Chromatography) |
20~40 |
| Host Cell Protein (HCP) |
ELISA (Enzyme-Linked Immunosorbent Assay) |
20~40 |
| Host Cell DNA (HCD) |
qPCR (Quantitative Polymerase Chain Reaction) |
20~40 |
| Residual RNA |
qPCR |
20~40 |
| Residual Protein |
BCA (Bicinchoninic Acid) |
20 |
| Residual Antibiotics |
ELISA |
20~40 |
| Residual Defoamers |
HPLC |
20~40 |
| Residual Triton X-100 |
HPLC |
20~40 |
| Residual Tween-20/ Tween-80 |
HPLC |
20~40 |
| Other Product/Process Related Impurities |
HPLC, ELISA, etc. |
TBD |
Related Services
Quality Control (QC) and Stability Studies
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