Quality Control

QC-Quality Control System (GMP)

Based on rich GMP quality management experience, Yaohaibio provides customers with continuous and stable quality services in raw materials and excipients testing, in-process control, stability study and product release testing, etc. for biopharmaceuticals through close cooperation between the quality control (QC) team and production and quality assurance teams. Meanwhile, a complete quality control system that meets the requirements of various regulations is established to support the comprehensive certification at all stages of QC inspection.

Services

Analytical method transfer/verification/validation
Strain bank release testing, passaging stability, storage stability
Release testing of raw materials and excipients
Release testing of intermediate products, drug substance, semi-finished products, and finished products
Testing and standardization of in-house reference standards
Stability study

Service Characteristics

Advanced quality analysis and testing equipment

Member of QC team have undergone strict GMP training and guidance, and are familiar with the specifications required by the new version of GMP

Proficient in various physiochemical, biological, and microbiological quality control testing methods

QC team members are rich in project implementation experience

The testing range is continuously expanding in addition to the current testing range

Bioanalytical Testing Services

Currently, Yaohaibio has established a comprehensive physiochemical, microbiological, and biochemical quality testing platform. Product-specific quality control methods are adopted according to the physiochemical characteristics of the products, which can meet the release testing requirements of biological products (recombinant proteins, peptides, plasmids) and satisfy the analysis and quality control requirements of the life cycle of biopharmaceuticals.

Classification	Biochemical testing items	Physiochemical testing items	Microbiological testing items
Test Items	Expression quantity of the targeted product	Appearance	Plasmid loss rate
	Macrorestriction map of the plasmid	PH	LB agar plate streaking
	Protein content	Visible foreign matters	Dyeing microscopy
	Purity	Filling volume	Trinactin
	Molecular weight	Osmotic pressure	Resistance to antibiotics
	Activity testing	Particulate matters	Biochemical reaction
	Exogenous DNA residues	Moisture	Antibiotic residues
	Host bacteria protein residues	Density	Bacterial endotoxins
	Isoelectric point	Residual organic solvent	Microbial limits
	UV spectroscopy	Optical rotation	Sterility
	Peptide map
	Identification

Testing Capability

We can perform about 30 testing items by 50 testing methods in the lab, the testing capability is continuously improving.

30+Test Items

50+Test method

Service Cases

Recombinant protein project experience

Experienced in the full testing of recombinant protein projects through successfully serving 100+ projects, including multiple PEGylated protein projects and enzyme product projects.
Plasmid project experience

Experienced in HCD and HCR testing in key projects through the service experience on multiple projects of therapeutic plasmid products and viral vector products
VLP vaccine project experience

Successfully provided VLP vaccine testing for multiple projects, proficient in VLP particle specification and testing items
Analytical method verification/validation

Completed 150+ analytical method transfer/verification/validation tasks
Stability study

Successfully undertaken dozens of individual stability study projects

Recombinant protein project experience

Plasmid project experience

VLP vaccine project experience

Analytical method verification/validation

Stability study

Focus on
microbial expression system
CDMO service leader

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