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 / ICH S7B Q&A	CHO / HEK 293	Moxifloxaxin, Ondansetron, Dofetilide
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
NaV1.5	CHO	Quinidine
NaV1.5 / ATXII activated late current	CHO	Ranolazine
CaV1.2	CHO	Nifedipine / Verapamil

 

• 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/E14/S7B Q&A 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]