EVALUATING OELS AT ALKERMES
A first step when considering the introduction of any new API is to assess the toxicity and potency of the compound and to categorize it (“control banding”). Alkermes, for example, developed a categorization scheme with input from SafeBridge Consultants. Alkermes considers this an important first step in facilitating the assessment of likely product demands relative to the capability of existing manufacturing equipment technology and/or the ability to enhance its processing approach. Control banding provides a means to group materials by their hazards and risk of exposure so that suitable consistent controls can be defined and applied to ensure safe handling.