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A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include...

Sterility testing of cell lines, media, in-process material, and final products must be performed during the manufacture of pharmaceuticals and...

Testing for mycoplasma is required for biologicals produced for clinical investigation and as licensed biologicals including: Recombinant...

Every lot of product produced, both for preclinical and clinical studies, requires a series of tests to ensure active ingredients are free of...

Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and...

Perhaps the most critical of tests, lot release testing is the final requirement before reaching the patient population. Speed and reliability...

Why Perform a Viral/TSE/Microbial Clearance Study? A major concern for many biologics is viral contamination. The ICH Q5A regulatory guideline...

Enzyme Linked Immuno Sorbent Assay (ELISA) is a commonly used test that utilizes antibodies to detect and quantify specific analytes such as...

When using cell lines for production of a biotechnology product or biological, adventitious agents are a major concern and In Vitro testing is...

A working cell Bank (WCB) is more commonly required at the later stages of therapeutic development and manufacturing. This bank is produced from...