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 various types of recombinant proteins or peptides, e.g., Recombinant Vaccines, VHH/Nano-Antibodies, Antibody Fragments, Hormones, Cytokines, Growth Factors (GF), Enzymes, Collagens, Fusion or Conjugated Proteins and any other microbial-based Proteins/Peptides.
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
- Protein Characterization (physicochemical and structure); Comparability and Similarity Assessment
- Technology transfer to QC
Method Development and Pre-validation:
| Quality Attributes |
Analytical Methods |
Delivery Time (Working Days) |
| Total Protein Content |
UV (Ultraviolet), BCA (Bicinchoninic Acid), Bradford, Lowry |
20 |
| Target Protein Identity |
WB (Western blotting) |
20 |
| Purity, Size Variants |
SEC-HPLC (Size Exclusion Chromatography-High Performance Liquid Chromatography) |
20~40 |
| CE-SDS (Capillary Electrophoresis-Sodium Dodecyl Sulfate) |
20~40 |
| Purity, Charge Variants |
IEX-HPLC (Ion-Exchange High Performance Liquid Chromatography) |
20~40 |
| iCIEF (Imaged Capillary Isoelectric Focusing) |
20~40 |
| Purity, Hydrophobicity |
RP-HPLC (Reverse Phase High Performance Liquid Chromatography) |
20~40 |
| HIC-HPLC (Hydrophobic Interaction Chromatography-High Performance Liquid Chromatography) |
20~40 |
| Peptide Mapping |
HPLC (High Performance Liquid Chromatography) |
20~40 |
| MS Peptide Mapping |
LC-MS (Liquid Chromatography-Mass Spectrometry) |
20~40 |
| Isoelectric Point (pI) |
cIEF (Capillary Isoelectric Focusing) |
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 Antibiotics |
ELISA |
20~40 |
| Residual IPTG |
HPLC |
20~40 |
| Residual Defoamers |
HPLC |
20~40 |
| Residual Triton X-100 |
HPLC |
20~40 |
| PEG Content |
HPLC |
20~40 |
| Residual Tween-20/ Tween-80 |
HPLC |
20~40 |
| Other Product/Process Related Impurities |
HPLC, ELISA, etc. |
To Be Determined (TBD) |
Related Services
Protein Structure Characterization
Quality Control (QC) and Stability Studies
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