Handling category 5 materials, such as highly potent active pharmaceutical ingredients (HPAPIs) and cytotoxic compounds, demands much more than standard lab protocols. These substances, mainly used in oncology as part of antibody-drug conjugates (ADCs), are biologically active at extremely low doses. Their toxicity and therapeutic potential are closely linked, and so is the risk to your staff, your product, and your development timeline.

Whether you are preparing for clinical trials or commercialisation, the Eurofins BioPharma Product Testing (BPT) network of laboratories can support the testing of highly potent standalone therapies, ADCs, and combination products with the highest level of safety and precision.

We have invested substantially in the capabilities required to test these materials effectively. Our mix of newly built and upgraded high-containment laboratories are designed specifically for Category 5 compound testing. These facilities are equipped with isolators, gloveboxes, HEPA-filtered weighing stations, and negative pressure systems to ensure a fully contained environment, including the newly acquired Skan PURE isolator for sterility testing of highly toxic substances.

Our specialist facilities feature:

• Controlled air pressurisation with restricted access and airlocks
• Isolators and gloveboxes for standard aliquoting, release, and stability testing
• Negative pressure sterility testing environments 

In addition to technical infrastructure, we implement:

• Robust Personal Protective Equipment (PPE) protocols including sleeve protectors, goggles, and adapted working clothes
• Comprehensive waste management with HP-specific containers and leak-proof systems
• Local exhaust ventilation and containment at every stage of handling

Our expertise includes the ability to execute extremely sensitive analytical methods, such as those required for cleaning validation and cross-contamination assessments, using chromatography coupled with mass spectrometry.

People are our first line of defence. That’s why we provide rigorous personnel training to ensure safe handling, prevent contamination, and support compliance with global regulatory expectations. Each team member working in our high-containment labs is trained to the highest standards.

From method development to release testing, Eurofins BPT delivers comprehensive solutions for your most complex, high-potency pharmaceutical compounds. Our commitment to containment, compliance, and continuous improvement helps to ensure your project, and your people, are in safe hands.