HIGH POTENCY APIS
and the associated requirements for payloads and linkers , which are the core elements of ADC activity , has led to wider general use of Band 6 , as many payloads have OELs below 200 ng / m 3 .
It is important to keep in mind that some names or banding denominations may be misleading and to ensure that the band numbering is exemplified by its OEL limits because some OEB systems show major variation on the limits and can lead to an incorrect containment strategy .
In addition , the use of ‘ highly potent ’ terminology is not only linked to the OEB . Indeed , some organisations may advertise their HPAPI capability as being Band 4 , while others , more versed with the handling of such a substance , limit HPAPI terminology to substances within Band 5 and above .
Recent complications
In the case of APIs in the early phase of the development , the OEB attribution must often be completed with a limited amount of information available . A couple of decades ago , the development approach was more sequential and the API was prepared in the early days because there were fewer preclinical activities to undergo .
Over the last decade , with the drive to bring the medicine to the patient more quickly , larger quantities of APIs , less well characterised in terms of potency , have to be delivered earlier . This supported a review of the default banding approach in the industry , leading most new molecules in the pre-clinical phase to be considered as part of OEB 4 .
According to industry best practices , companies should ensure their facilities meet the required engineering controls for both plant and equipment items ( such as air pressure relationships , containment and process technology ) and programme items ( such as process safety , training , medical surveillance , industrial hygiene , toxicology and environmental control ).
These specific engineering controls are applied from the facility level to individual pieces of equipment . At facility level , a company needs appropriate HVAC systems , airflow
Figure 1 – Occupational exposure , banding & typical containment strategies
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