Interest Group

(Bio-)pharmaceutical companies / institutes with LOT-Release relevant questions (pharmacopoeia compliant testing), manufacturers of cell culture products for the GMP sector.

Description

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

Method

Kinetic Chromogenic or recombinant Factor C

Applied LAL System

Chomo – LAL or Recombinant factor C

Sample Preparation

Included

Process Control

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

0.005 EU/ml

EP 2.6.14 conformity

Yes.*

Validation

Pharmacopoeia pre-scribed method, matrix validation required.

Sample Requirements

Depending on matrix dilution and characteristics.

Order No.

Custom

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.