Host Cell DNA Contamination Detection
The elimination of host cell impurities is a signiﬁcant step in the puriﬁcation of biopharmaceutical products. Consistent with the Regulatory guidelines, the DNA content in the ﬁnal product lower than the deﬁned limitations. In recent years, Livogen Pharmed has produced Host Cell DNA (HCD) determination kits that can speciﬁcally quantify the trace amount of residual DNA in biopharmaceuticals. These kits have been designed based on real-time PCR method and provide highly-sensitive analysis with a low detection limit.
The HCD kits currently produced by Livogen Pharmed are as following:
- Escherichia coli HCD Kit
- Pichia pastoris HCD Kit
- SP2/0 HCD Kit
- BHK HCD Kit
- CHO HCD Kit
In addition to HCD kit production, Livogen Pharmed provides speciﬁc HCD determination services for mentioned cell lines in validated analysis. With a sound knowledge of regulatory requirements and technical procedure, the R&D team of Livogen Pharmed is ready to fabricate customized kits/services regarding quantiﬁcation of residual host cell DNA for biopharmaceutical companies and research institutes.
Furthermore, R&D team of Livogen Pharmed are working on design and fabrication of host cell protein and protein A determination kits via ELISA methodology.