The Significance of Quality Control for Biologics
Pharmaceutical quality is the cornerstone that gives patients and consumers confidence in the safety and effectiveness of their medications.
The Quality Control (QC) and release of all raw materials, bulk solutions, in-process materials, drug substances (DS), and drug products (DP) play a critical role in the research and manufacturing program, ensuring batch-to-batch consistency.
Quality Control Services of Yaohai Bio-Pharma
Yaohai Bio-Pharma, a contract development and manufacturing (CDMO) servicer, performs high-quality and cost-effective bioanalytical services supporting our clients in QC and Batch Release for GMP biologics from pre-clinical to commercial stage.
We design QC Testing for appearance, identification, activity, purity, and impurities, following International Council for Harmonization (ICH) Quality guidelines, relevant Pharmacopoeia (EU and US monographs), regulatory guidelines (ICH, FDA, and EMEA), and Good Manufacturing Practice (GMP)/ Good Laboratory Practice (GLP) practices.
We are experts in Quality Control of Proteins and Quality Control of Plasmid DNA.
Testing Techniques
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Biochemical Testing
Ultraviolet (UV)
Gel electrophoresis – Agarose, SDS-PAGE, Western blot (WB)
Colorimetric (UV/ Visible, VIS), Fluorescence & Chemiluminescence activity assays
Nuclease (nicking and fluorescence-based) and Protease (electrophoresis and fluorescence-based) analysis
Host cell protein (Enzyme-Linked Immunosorbent Assay, ELISA) and DNA (Picogreen and qPCR)
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Physicochemical Testing
Osmolality, pH, and conductivity
High Performance Liquid Chromatography (HPLC),
Size Exclusion Chromatography (SEC),
Ion Exchange Chromatography (IEX)/Charge Variant,
Hydrophobic Interaction Chromatography (HIC),
Reverse Phase Chromatography (RP) and Ultra High-Performance Liquid Chromatography (UHPLC)
Microfluidic- Microchip, Isoelectric Focusing (IEF)
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Microbial
Endotoxin-Limulus Amebocyte Lysate (LAL) (Kinetic-QCL), United States Pharmacopeia (USP)/European Pharmacopeia (EP)
Bioburden and Sterility (USP/EP)
Plaque assays
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Cell-based Potency
Cell transfection, ELISA, Flow cytometry, Surface Plasmon Resonance (SPR)
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Protein Structure Characterization
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Stability Studies
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Our Experience
Yaohai Bio-pharma has experience working with many classes of large molecules including but not limited to:
Peptides: Conjugated peptides, PEGylated peptides, fusion peptides
Proteins: Glycosylated proteins, non-glycosylated proteins, fusion proteins, conjugated proteins, monoclonal antibodies (mAbs), polyclonal antibodies, bispecific antibodies, oligosaccharides, vaccines
Nucleic Acid: Plasmid DNA, mRNA
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