Testing Services - BINHUI BIOPHARM

Testing

Services

Binhui Bio provides testing services related to biological products, such as impurity limits, biological titer, microbial contamination, etc., in accordance with the requirements of Chinese Pharmacopoeia (ChP), United States Pharmacopoeia (USP), and other laws and regulations, meeting the requirements of products in each stage.

Service

content

Bioburden Monitoring

Sterility Test

Microbial Limit Test

Bacterial Endotoxin Test

Bacterial endotoxin test

Abnormal Toxicity Test

Abnormal toxicity test

Biological Activity and Titer Test

Virus Titration

Neutralizing Antibody Titration

In vitro Oncolytic Activity

Impurity Limit Test

Protein Content Test

BSA Residue Test

Host DNA Residue Test

Particle Size Distribution Test

Service

features

Establish and optimize analytical methods

Experienced QC inspectors and laboratory managers

Well equipment and facilities to complete relevant tests

GMP compliant laboratory for microbiological examination and a cGMP PCR testing laboratory

Implementing strict confirmation and acceptance control rules for test materials

Testing Service Manual

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Testing Service Manual

Consultation and purchase Product and Service Manual