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Yaohai Bio-Pharma provides integrated pharmaceutical quality control services supported by robust quality systems. Our QC team delivers raw material testing in pharmaceuticals, in-process control testing, QC microbiology testing, analytical method validation, stability studies, and GMP release testing to support consistent quality across development and manufacturing.
Contact our team to learn how our pharmaceutical quality control services can support your development, manufacturing, and release testing needs.
Our platform is supported by robust pharmaceutical quality management systems and designed to strengthen quality control for the pharmaceutical industry. From analytical method validation to release testing, we provide integrated support for effective process and quality management.
Our pharmaceutical quality control platform combines pharma quality systems, advanced QC testing capabilities, and broad project experience to support reliable quality management across drug development, manufacturing, and final release.
Experience across analytical method transfer, analytical method verification, and analytical method validation projects.
Equipped with advanced analytical and QC testing instruments to support reliable pharmaceutical quality control.
QC professionals receive comprehensive GMP training and follow current industry standards.
Proficient in physicochemical, biological, and QC microbiology testing for diverse product types.
We continuously expand our analytical capabilities to support evolving client needs.
Successfully supported nearly 100 independent stability studies across different projects.
Supported 100+ recombinant protein projects, including multiple PEGylated proteins and enzyme projects.
Supported multiple therapeutic plasmid and viral vector projects, with experience in HCD and HCR testing.
Completed multiple VLP vaccine testing projects with rich experience in particle quality standards and assay specifications.
Our pharmaceutical quality control platform supports a broad range of routine assays across development, manufacturing, and release. With more than 30 testing projects and 50 analytical methods, we provide flexible QC testing support for diverse product and process needs.
Testing Projects
Analytical Methods
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Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.
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At Yaohai Bio-Pharma, our QC system covers the entire lifecycle of biologics development and manufacturing. This comprehensive approach includes raw material and excipient release testing, in-process control testing, stability studies, and final release testing for intermediate products, drug substances, and finished drug products. Our laboratory is equipped to perform over 50 specialized physicochemical, biochemical, and microbiological testing methods.
Raw material testing is critical to verify that all incoming materials meet predefined, stringent quality specifications before they enter our GMP facilities. This proactive testing mitigates contamination risks, supports batch-to-batch consistency, and ensures strict alignment with NMPA, FDA, and EMA regulatory expectations.
IPC testing is performed continuously during manufacturing to monitor critical quality attributes (CQAs) and ensure the process remains within defined critical process parameters (CPPs). By applying Quality by Design (QbD) principles, our IPC strategy enables real-time process monitoring, ensuring high yield and uncompromised product purity.
Our dedicated QC team has extensive experience, having completed over 150 analytical method transfer, verification, and validation activities.
GMP release testing is the final, essential quality gate to confirm that a material meets all approved specifications before clinical or commercial release. Our expert team conducts rigorous release testing across various complex modalities, including recombinant proteins, plasmids, mRNA, and single-domain antibodies, ensuring they are safe, pure, and ready for use.
Stability studies evaluate how the quality of your biological material or drug product changes over time under specific, controlled storage conditions. We have successfully conducted dozens of individual stability study projects. The data generated is crucial for establishing accurate shelf life, defining storage recommendations, and supporting your IND/NDA regulatory submissions.
