Isoenzyme Assays
Manipulation
of multiple mammalian cell lines in the same facility introduces
the possibility that cell culture cross-contamination can occur.
Therefore, confirmation of the purity and identity of biopharmaceutical
production cell lines are required for the regulatory acceptance
of drug product. Isoenzyme analysis is a suitable cost effective method in most cases,
and the molecular methods are generally suitable when there is risk
of cross-contamination with a cell lines of the same species (for
example HEK293 and Per.C6).
Vitrology
performs isoenzyme assays with the AuthetiKit™ system. AuthetiKit™
defines a set of enzymes with a characteristic "mobility pattern"
for each specimen. Isoenzymes from different species result in different
electrophoretic mobilities. The following seven enzymes can be examined:
AST (aspartate aminotransferase), G6PD (glucose-6-phosphate dehydrogenase),
LDH (lactate dehydrogenase), MDH (malate dehydrogenase), MPI (mannose
phosphatase isomerase), NP (nucleoside phosphorylase), PEP B (peptidase
B). Commonly used cell lines in the biotechnology industry originate
from four animal species: Chinese hamster (CHO), mouse (NS0), Cercopithecus
monkey (Vero), Canine (MDCK), and human (HEK 293, Per.C6, MRC-5).
Vitrology uses a minimum of four identification enzymes for cell
line identification.
SP-M.8400
Isoenzyme Assay for Cell Line Identification
Potential
Cell Mixture |
Distinguishing
Enzymes |
Mouse
and Chinese hamster |
PEP
B |
Human
and Vero |
AST
or MDH |
Chinese
and Syrian hamster |
MDH |
Human
and Chinese hamster |
MDH |
Human
and Mouse |
Human
and Mouse LDH |
Insect
and Mammal |
NP
or G6PD |
Microbial Identity Assays
Microbial identity assays and Phage detection will become available.
Please contact us for further details.
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