Yaohai Bio-Pharma has been involved in the protein quality control and batch release of various large molecules, including Recombinant Subunit Vaccines, Single-domain Antibodies (sdAbs), Antibody Fragments, Hormones/Peptides, Cytokines, Growth Factors (GF), Enzymes, Antigens, Collagens, etc.
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 EMEA), 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 |
Protein concentration |
UV, BCA, Bradford, Lowry |
| Potency |
Enzyme-linked Immunosorbent Assay (ELISA), Flow cytometry, Surface Plasmon Resonance (SPR), cell-based assays |
| Identity |
Primary and higher order structure |
Structure characteristics |
| Isoelectric point (pI) |
Capillary Isoelectric Focusing (cIEF) |
| Target protein |
Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE), Western Blot (WB), ELISA |
| Peptide mapping |
High Performance Liquid Chromatography (HPLC） |
| Enzyme activity |
UV or other validated methods |
| Product-related impurities |
Hydrophobicity |
Reversed-phase chromatography (RPC) Hydrophobic interaction chromatography (HIC) |
| Charge |
Ion exchange chromatography (IEC) Capillary zone electrophoresis (CZE) Isoelectric focusing (IEF) |
| Size (Aggregates, truncated forms) |
SDS-PAGESize exclusion chromatography (SEC) capillary gel electrophoresis (CGE) |
| Process-related impurities |
Residual endotoxin |
Gel method, chromogenic method |
| Host cell protein, HCP |
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 Experience
Yaohai Bio-pharma has experience working with many classes of large molecules including but not limited to:
Peptides: Insulin, Glucagon-like peptide-1 (GLP-1), growth hormone, hirudin, scaffold protein, and any other conjugated peptides or fusion peptides.
Subunit Vaccines: Respiratory Syncytial Virus (RSV) subunit vaccine, Human Papillomavirus (HPV) VLP, Hepatitis B Virus (HBV) VLP, Qβ VLP (as carrier protein), VLP encapsulating RNA fragment.
Antibody fragments: Fab fragments and Single-domain antibodies (sdAbs) for therapy and diagnosis.
Cytokines/Growth factors: Interleukin (IL), Interferon (TNF), Fibroblast Growth Factor (FGF), Epidermal Growth Factor (EGF), Colony Stimulating Factor (CSF), Transcription Factors (TF), etc.
Enzymes: CRISPR-associated protein 9 (Cas9), Urate Oxidase, IgG-degrading protease (IdeS), Nuclease and Protease.
Other Proteins: Parkin protein, Midkine, annexin 5 protein, allergen, and any other conjugated or fusion proteins.
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