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| Product Name: |
Host Cell Protein ***ection Kits
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| Related proudcts |
host cell protein ***ection ki, |
| Specifications |
Host Cell Protein Detection Kits |
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CHO Host Cell Protein ELISA Kit, G1CHO Host Cell Protein ELISA Kit, G2E. coli Host Cell Protein ELISA Kit, G1HEK 293 Host Cell Protein ELISA Kit, G1Pichia Yeast Host Cell Protein ELISA Kit, G1Dilution Buffer
ISO13485 for host cell protein assay kit (for Research Use Only)
Medical Device Quality Management System Certificate
Scope of approval: Research and Development and Production of Cytokine Recombinant Protein, Host Cell Protein ***ection Kit (for Research Use Only)
Requirement of the Regulation (FDA, EMA, ICH)
FDA, EMA, and ICH all have precise regulations for the Host Cell Protein residues.
FDA requires that potential contaminants (including Host Cell Proteins ) introduced by the purification process should be below ***ectable levels using a highly sensitive method.
Requirement of the Regulation (FDA, EMA, ICH)
EMA also made a statement, Residual host cell DNA and residual host cell proteins are among the impurities to be eliminated, for HCP, whatever the product and production system, residual HCP has to be tested for on a routine basis.
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| Company: |
Bluegene Biotech
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| Contact: |
Blue gene |
| Address: |
Lane 166 Tianxiong Road(Rm.403,404, Bldg 2),Pudong NewDistrict,Shanghai |
| Postcode: |
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| Tel: |
400-882-6373 |
| Fax: |
400-882-6373 |
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