(Bio-)pharmaceutical companies / institutes with LOT-Release relevant questions (pharmacopoeia compliant testing), manufacturers of cell culture products for the GMP sector.
According to EP 2.6.14, Endotoxin testing methods must be validated on a sample-specific basis. Minerva Analytix GmbH offers customized method validation in a GMP environment with years of experience. The validation can be performed for all BactToxins assays.
Recommended Sample Material
e.g. ATMPs, media and starting materials, antibody formulations
Kinetic Chromogenic or recombinant Factor C
Applied LAL System
Chomo – LAL or Recombinant factor C
According to EP 2.6.14
Sample Volume / Reaction
Dilution-dependent, 1 – 100 μl
Average Turnaround Time
Depending on validation scope about 7-14 days
Sensitivity of Method
EP 2.6.14 conformity
Pharmacopoeia pre-scribed method, matrix validation required.
Depending on matrix dilution and characteristics.
Volume Discount Available
yes, on request
*Recombinant Factor C is an alternative method, according to pharmacopoeia a parallel product-specific validation with e.g. chromogenic LAL must be performed.