Quality Control
Quality Control provides analytical services (microbiological and physico-chemical) in full support of the Production capabilities in GenIbet. This includes:
- Environment monitoring to ISO classification
- Raw materials analysis to Ph. Eur.
- In-Process-Control sample analysis of processes
- Finished products analysis for the final product in accordance to Client Specification
Quality Control is a critical part of GenIbet and a major factor in the successful manufacture of biotechnology products.
In addition to the support of Production, Quality Control also provides clients with method development and method Validation (in accordance with ICH and other regulatory guidelines). Together with IBET’s Analytical Services Unit, GenIbet Quality Control has extensive experience in a number of different techniques, namely:
- Cell Based assays
- In vitro potency assays
- Protein quantification
- Molecular biology and omics methods
- Detection and quantification of impurities or contaminants in pharmaceutical formulations such as endotoxins and host cell DNA.
Quality Control provides the centre piece to GenIbet capability as a provider of Biotechnology products and services.
