Formulation development is a long, ongoing process during a candidate’s lifecycle. Broadly, it’s segmented into three categories: pre-formulation, formulation, and process development. The work of pre-formulations groups is to begin the stability-indicating assays, and identify (and sometimes finalize) lead excipients. Their goal is to find optimal conditions to keep new biologic drug candidates soluble and active for further study, and eventually scale-up. This article covers five considerations for butter optimization during biologics pre-formulation. Click the link below to read more.
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