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Quality & Safety Analysis

Explore BIORI products for biopharma quality and safety analysis, organized around microbial testing, host-cell DNA analysis, host-cell protein ELISA, and process impurity testing. Use the subcategories to move from the analytical need to the relevant product family and exact product page.
Assay scope, standards, controls, sample preparation, acceptance criteria, and intended use are product-specific. Review the current protocol and validate the selected method in your own process and matrix. BIORI can discuss product selection, available documentation, samples, custom assay development, and technical support within an agreed project scope. Audit support does not guarantee an audit outcome.

BP-QN299-50
Detects Spiroplasma contamination by probe-based qPCR.
BP-QN88-100
Quantifies residual CHO host-cell DNA by probe-based qPCR.
BP-QN15-50
50-reaction qPCR kit for qualitative Mycobacterium DNA contamination detection.
BP-QN54-100
qPCR kit for quantitative human host-cell DNA detection.
BP-QN21-100
qPCR kit for Sf9 and AcNPV residual DNA detection.
BP-QN120-100
qPCR kit for quantitative plasmid DNA residue detection.
BP-QN10-100
qPCR kit for RCL copy-number detection in lentiviral-vector products.
BP-QN09-100
qPCR kit for quantitative HEK293 host-cell DNA detection.
BP-QP-H005
Quantifies HEK293 HCP in bioproduct samples by sandwich ELISA.
BP-QN99-50
Detects bacterial DNA contamination by probe-based qPCR.
BP-QN78-50
Detects fungal DNA contamination by probe-based qPCR.
BP-QN24-100
Quantifies residual E. coli DNA by probe-based qPCR.
BP-QN22-50
Detects Mycoplasma DNA contamination by probe-based qPCR.
BP-QN188-100
Extracts bacterial and fungal nucleic acids using magnetic beads.
BP-QP-T009-96
Quantifies T7 RNA Polymerase by sandwich ELISA.
BP-QP-R014-96
Quantifies RNase Inhibitor by sandwich ELISA.

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