Comprehensive Cell and Gene Therapy Testing Capabilities

Advanced Therapy Medicinal Products (ATMPs), such as Cell & Gene therapy products, are rapidly emerging as favourable alternatives for the treatment of a variety of rare diseases, cancer, and autoimmune disorders due to their targeted efficacy and high potency. Due to the complexity of these medicinal products, a large effort must go into the characterisation of drug products, drug substances, intermediate processes, raw materials and analyses of potential residues and contaminants in order to fulfil regulatory expectations.

Eurofins BioPharma Product Testing Italy has been active in the testing of ATMPs for several years. We provide a package of GMP-compliant services to address the identity, potency, purity, and safety of all ATMPs, such as starting materials, intermediate products, vectors, and final drug products. We also support manufacturing process development and validation.

Dedicated services and experienced analysts for ATMPs will support you throughout all the phases of your assay development/validation.

Eurofins BioPharma Product Testing is remarkably active in ATMPs testing since several years offering complete testing solutions to support clients to get products to the market and then to support release campaign through QC tests.

Following matrixes can be analysed and characterised:

• Raw materials
• Cell banks
• Plasmid vector
• Bulk vector harvest
• Intermediate Process/Drug Substances/Drug Product
• Viral Banks

Each project can be managed according to Fee For Service Model (FFS) or according to Full Time Employee (FTE) model based on client needs and requirements as well as allocate a Project Manager that will follow the entire project’s flow.