CiPA

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. 

B‘SYS operates via independent QAU (Quality Assurance Unit) for inspection of GLP studies. Study related GLP records are stored in the GLP archive along with training, calibration, and maintenance record sheets. Hallmark of GLP studies are the defined study accomplishment and precise execution.

GLP (Good Laboratory Practice) serves as quality management system concerning the organizational conditions under which non-clinical safety studies are accomplished. The test results generated in accordance with GLP principles in an OECD member country.

GLP validated patch clamp assays

Target Classic Protocol CiPA Protocol
hERG Available Available
hERG Trafficking Available Available
NaV1.5 Available Available
NaV1.5 (Late current) Available Available
CaV1.2 Available Available
Kv1.5 Available Not yet available
Kv7.1 / minK Available Not yet available

 

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]