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Establishment
of residual DNA as well as protein Analysis
is very essential regulatory requirement for
safety evaluation of the Biopharmaceutical
product, primarily because, they are derived
from a complex expression/production system
that often involves the use of genetically
modified host cells [i.e. bacteria, yeast or
mammalian cell lines]. The presence of Host
cell DNA and Protein in the final product is
of significant concern due to transfer of
activated cellular and/or viral oncogenes
and immunogenicity. The World Health
Organization (WHO), the European Union (EU)
and FDA recommended level of DNA and Protein
Contamination in finished Biopharmaceutical
samples.
JRF has
started Residual DNA and Protein Analysis as
a service for detection and quantification
of DNA and Protein by qRT-PCR and ELISA
respectively for the regulatory submission
of bio-pharmaceutical products. JRF can
offer residual Host cell DNA analysis for
the host cells i.e. CHO, E. coli.
HEK293/PER.C6, Canine(MDCK) by qRT-PCR and
residual cell protein for the host cells
i.e. CHO, E. coli, HEK, Lactococcus lactic,
Saccharomyces cerevisiae, SF9, MRC5, SP2/0
and total Goat proteins with ELISA.
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