GLP / CiPA

B‘SYS is organized as GLP (Good Laboratory Practice) test facility and since 2004 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 Gene Species Disorder Manual Automated    
KV11.1 (hERG) / peak tail current KCNH2 human LQT Syndrome 2 0 1
KV11.1 (hERG) / trafficking KCNH2 human LQT Syndrome 2 0 0
NaV1.5 / peak current SCN5A human LQT Syndrome 3 0 0
NaV1.5 / late current SCN5A human LQT Syndrome 3 0 0
NaV1.5 / ATXII-activated late current SCN5A human LQT Syndrome 3 0 0
CaV1.2 / peak current CACNA1C/CACNB2/ CACNA2D human Autism / Heart function / Psychiatric Disorders 0 1
KV7.1 (KVLQT1) / minK / steady state current KCNQ1/KCNE1 human LQT Syndrome 1/5 0 1

GLP-validated CiPA patch-clamp assays

Measured according to the CiPA protocols

Target Gene Species Disorder Manual Automated    
KV11.1 (hERG) KCNH2 human LQT Syndrome 2 0 0
KV11.1 (hERG) / trafficking KCNH2 human LQT Syndrome 2 0 0
NaV1.5 SCN5A human LQT Syndrome 3 0 0
CaV1.2 CACNA1C/CACNB2/ CACNA2D human Autism / Heart function / Psychiatric Disorders 0 0
KV1.5 KCNA5 human Heart function 0 0
  • Independent QAU (Quality Assurance Unit) for inspection of GLP studies
  • GLP certificate
  • Archiving of GLP records for 10 / 15 years
  • GLP hERG assay validated to be performed according to ICH S7B Guidelines
  • 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 >> 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]