Safe Evaporative Sample Preparation of High Potency APIs
Jan 30 2019
Genevac recently provided a leading pharmaceutical company with a glovebox-enclosed version of its EZ-2 centrifugal evaporator to safely remove solvents from cytotoxic drug preparations.
Cytotoxic drugs are used widely in the treatment of cancers as well as other diseases. Antibody drug conjugates are a class of highly potent therapeutic drugs used for treating targeted cancerous tumours. These chemotherapeutic drugs can be 100- to 1000-times more toxic than traditional anticancer agents and extreme care should be taken when handling.
Working in conjunction with leading containment systems specialists Flow Sciences, SP Scientific adapted an EZ2 Elite Evaporator to operate within a bespoke safety-vented enclosure for the containment of cytotoxic drugs such as antibody drug conjugates. The resultant engineered solution, comprising two chambers protected with Hybrid Isolator Technology, allowed the use of bag-in/bag-out HEPA containment.
Access to the EZ2 Elite evaporator and associated process appliances was achieved with removable glove panels. Working with the pharmaceutical client, SP Scientific and Flow Sciences were able to produce, install and certify a custom enclosure for evaporative sample preparation of high potency active pharmaceutical ingredients (HPAPI).
The EZ-2 Elite Centrifugal Evaporator from SP Scientific is a compact parallel evaporator equipped with leading-edge technology to evaporate samples efficiently and safely. Benefiting from a high-performance scroll pump, which delivers deep vacuum, the EZ-2 Elite is able to routinely remove all common organic solvents including DMSO and NMP. In addition, internal heating of vapour duct and system components ensures that such challenging solvents only collect in the SpeedTrap condenser, and not anywhere else. The SpeedTrap condenser on the EZ-2 Elite comes the benefit of automatic defrost and drain technology, which is ideal when handling HPAPI applications as no user interaction is required. The system is compatible with a wide selection of sample holders enabling evaporation from most common sample container formats, including round-bottom flasks up to 500ml, tubes up to 160mm long and custom reaction blocks, as well as shallow and deep-well microplates.
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