Quality Research Support Service
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Quality Research Support Service

The quality research team of Yaohai Bio-Pharma is highly experienced in analyzing biological products, including mainstream biological products such as recombinant proteins, plasmids, cytokines, vaccines, etc. On the back of a mature analysis platform and advanced analytical instruments, we provide quality analysis services conforming to laws of drug CMC stage, including specification establishment, analytical method development/optimization, qualification/validation, transfer; stability pre-study, preparation and inspection of reference standards, etc. Moreover, We provide the quality research services for biological products throughout from preclinical study to GMP production.

Original strain testing and stability study

Process development sample analysis

Identification, assay, purity, activity, impurities, etc.

Analytical method management

Analytical method development/optimization: biochemical activity; purity, excipient content, process residues (HPLC), etc.

Method qualification/validation

Method transfer

Specification establishment (including strains, drug substance, drug products, etc.)

Recombinant proteins



Stability pre-study

Preparation, standardization and characterization of reference standards

Our analysis platform is equipped with advanced analysis instruments including HPLC, UHPLC, CE, fluorescent PCR, fluorometer (Qubit), multimode microplate reader, gel imaging system, nanometer particle size analyzer, UV spectrophotometer, osmotic pressure meter and stability study chamber, etc., which can provided high qualified analysis and testing services for customers.

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