GenIbet is a biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies. GenIbet’s core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing for Phase I and II clinical trials.

 

 

 

Our Services

 

1. cGMP Bulk Biopharmaceutical Production
2. cGMP Master and Working Cell Bank Production
3. cGMP Master and Working Virus Seed Stock Production
4. cGMP Cell and Gene Therapy Production
5. Fill and Finish
6. Quality Control and Quality Assurance Services

 

 

 

 

 

 

 

As a leading European CRO based in Belgium, Quality Assistance provides (bio)pharmaceutical companies with the scientific, technical and analytical support needed to generate all the analytical data required for both investigational drug and marketing authorisation applications to national, European (EMA), American (FDA) and Japanese (PMDA) authorities.

 

With its 30 years’ experience in analytical sciences and all their analytical facilities on one site (premises of 5 200 m²), Quality Assistance has a unique position on the market thanks to their six laboratories (Molecular Biology, Cell Culture, Physico-chemistry, Mass Spectrometry, Bioanalysis and Microbiology) covering all the analytical technologies needed to support your drug development process. Their laboratories perform analytical development, stability testing including forced degradation, bioanalysis (PK, PD and biomarkers), biopharmaceutical testing and release testing for the EU.

 

Thanks to their skills and expertise and those of a network of reliable partners such as Cleancells, Quality Assistance provides a complete service package combining their analytical knowledge with the expertise of pre-clinical and clinical CROs.

 

Quality Assistance is GMP approved, GLP certified and GCLP compliant.

 

 

 

 

Since 2009, Clean Cells has signed a partnership agreement with P.A.R.I.S Biotech for the quality control of their production of antibodies.

 

 

 

 

 

Since 2005 Clean Cells has signed a partnership agreement with the Cellular and Genetic Treatment Unit of Nantes Hospital. We realize the production of therapeutic cell lines of our client clinical batches in phase I, II and III. THose clinical batches are controled in accordance with the current international regulatories and our GLP/GMP certifications.