약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 10.

Table. 10.

The differences in testing methods between recombinant pharmaceuticals and synthetic medicines

Classification Test methods in recombinant pharmaceuticals Test methods in synthetic medicines
Cell Bank Cell viability test etc. Not available

In Process Control Titer assay, Cell count test etc. Disintegration, Friability and Hardness test etc.

Chemical test Osmolality determination, Protein assay, Impurity test etc. Titration, Loss on drying, Residue on ignition test etc.

Biochemical test Enzyme Immunoassay(ELISA) Not available
Polymerase Chain reaction(PCR)
Electrophoresis(Gel electrophoresis)
Cell-based analysis test etc. * Instrumental analysis using HPLC, GC, Dissolution tester

Microbial test Mycoplasma test Not available
Adventitious virus test Not available
Microbial limit test Microbial limit test
LAL test for endotoxin LAL test for endotoxin
Sterility test Sterility test

Yakhak Hoeji 2021;65:1-9 https://doi.org/10.17480/psk.2021.65.1.1
© 2021 Yakhak Hoeji