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Host Cell DNA Contamination kit

HCD CHO/BHK ContaFind Kit

Recombinant protein production in mammalian cells is a widely established industry and one of the regulations that govern the use of mammalian host systems is the requirement to completely remove host cell DNA. While the effects of residual DNA contamination are still unclear, the transfer of host cell genetic material can be potentially harmful to the patient. According to the Food and Drug Administration (FDA) guidelines, the DNA content in the final product should be as low as possible as determined by the most sensitive method, with the maximum acceptable amount of residual host DNA being 100 pg/therapeutic dose. Traditional methods for the detection of species-specific DNA such as blot hybridization are laborious and lack sensitivity. This kit is based on Real-time PCR technique for determining the presence of host cell DNA contamination in products manufactured by recombinant expression in CHO or BHK cells.

Intended Use

  • Available for research use only (RUO). Not for use in diagnostic procedures.

 

HCD/E.coli ContaFind Kit

Recombinant protein production in mammalian cells is a widely established industry and one of the regulations that govern the use of mammalian host systems is the requirement to completely remove host cell DNA. While the effects of residual DNA contamination are still unclear, the transfer of host cell genetic material can be potentially harmful to the patient. According to the Food and Drug Administration (FDA) guidelines, the DNA content in the final product should be as low as possible as determined by the most sensitive method, with the maximum acceptable amount of residual host DNA being 100 pg/therapeutic dose. Traditional methods for the detection of species-specific DNA such as blot hybridization are laborious and lack sensitivity. This kit is based on Real-time PCR technique for determining the presence of host cell DNA contamination in products manufactured by recombinant expression in E.coli cells.

Intended Use

  • Available for research use only (RUO). Not for use in diagnostic procedures.

 

HCD Yeast ContaFind Kit

Recombinant protein production in mammalian cells is a widely established industry and one of the regulations that govern the use of mammalian host systems is the requirement to completely remove host cell DNA. While the effects of residual DNA contamination are still unclear, the transfer of host cell genetic material can be potentially harmful to the patient. According to the Food and Drug Administration (FDA) guidelines, the DNA content in the final product should be as low as possible as determined by the most sensitive method, with the maximum acceptable amount of residual host DNA being 100 pg/therapeutic dose. Traditional methods for the detection of species-specific DNA such as blot hybridization are laborious and lack sensitivity. This kit is based on Real-time PCR technique for determining the presence of host cell DNA contamination in products manufactured by recombinant expression in yeast cells.

Intended Use

  • Available for research use only (RUO). Not for use in diagnostic procedures.