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B‘SYS is organized as GLP (Good Laboratory Practice) test facility and is since 2004 thus reliably provides ion channel services in compliance with GLP principles for regulatory submission of compliant data. All GLP studies are supported by method validation procedures providing solid evidence of method suitability for regulatory purposes.
GLP validated patch clamp assays
Target/Assay | Test System | Validated reference compound |
hERG / peak tail current | CHO / HEK 293 | E-4031 |
hERG / trafficking | CHO | Pentamidine |
NaV1.5 / peak current | CHO | Propafenone / Quinidine |
NaV1.5 / late current | CHO | Anthopleurin C |
NaV1.5 / ATXII activated late current | CHO | Ranolazine |
CaV1.2 / peak current | CHO | Nifedipine |
KV7.1 / minK / steady state current | HEK 293 | JNJ 303 |
GLP validated CiPA patch clamp assays
Measured according to the CiPA protocols.
Target/Assay | Test System | Validated reference compound |
hERG | CHO | Verapamil |
hERG / trafficking | CHO | Pentamidine |
NaV1.5 | CHO | Quinidine |
NaV1.5 / ATXII activated late current | CHO | Ranolazine |
CaV1.2 | CHO | Nifedipine / Verapamil |
KV1.5 | CHO | S 9947 |
- independent QAU (Quality Assurance Unit) for inspection of GLP studies
- GLP certificate
- Archiving of GLP records for 10 / 15 years
- Generation of compliant data for regulatory submission according to ICH S7A/S7B Guideline
- B‘SYS is a certified Swiss GLP test facility Swiss GLP Test Facilities
Assay design and application schemes can be adapted to your needs.
Available options for GLP-assays:
- Full glass equipment
- Temperature control (RT or physiological temperature)
- Solubility tests
- Dose formulation analysis (GLP or non-GLP)
For more details or offers, please contact us: [email protected]