New Category 5 suites deliver ADC free-drug testing & payload prep at the industry’s only laboratory network for highly potent compounds of its kind
Daniel Peckman, M.S., BioPharmaceutical Sr Manager, Eurofins Lancaster Laboratories, US, DanielPeckman@EurofinsUS.com
Materials, such as the cytotoxic payload of an antibody drug- conjugate (ADC), can require strict handling guidelines and engineering controls such as dedicated isolators in order to protect those that come in contact with them due to their extremely low occupational exposure levels. With a significant increase in client requests for safe testing options of highly potent/toxic materials, Eurofins BioPharma Product Testing has built new 1,100 ft2 and 660 ft2 Category 5 laboratory suites with space for expansion. The addition of Category 5 testing areas within the Eurofins network in Lancaster, PA, and Columbia, MO, allow for specific stability and release testing to be performed on finished products that present safety challenges for traditional chemistry laboratories.
Eurofins’ state-of-the-art labs are built to safely test Category 5 materials where HPLC or spectrophotometric methods are required. Capabilities include controlled/ isolated receipt of shipped materials, weighing and solution preparation in isolation, and LC and UV-Vis analysis of APIs, drug substances or drug products. The increased control ensures the safety of the analysts while maintaining the same testing platforms applied in non-Cat 5 areas of the laboratory.
The suites comprise an entry corridor leading into a controlled access preparation room connected to an active room via entry and exit anterooms. Eurofins’ unique suite layout and design provide for a single directional flow of personnel and a cascade pressure gradient to protect the integrity of the inner room and isolate the active area from all other lab space.
Eurofins’ New CAT5 Labs offer:
- The ability to include free-drug testing of CAT5 level payloads within clients’ ADC stability and release testing panel
- Space to expand for additional testing on Category 5 compounds in the future
- Dedicated weighing and preparation isolators, HPLCs with UV and PDA detection, dedicated Biosafety cabinets and UV-Vis spectrophotometric capabilities.
Applications can range from potent compound weighing/aliquoting projects to HPLC testing for the determination of size, purity or chirality of APIs or free-drug payload.
With this new service offering, Eurofins BioPharma Product Testing delivers a one-stop-shop for comprehensive QC testing of antibody drug conjugates.
For more information, visit: www.eurofins.com/biopharma-services/product-testing/services/biopharma-product-testing-services/category-5-highlypotenttoxic- materials-testing/