Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products

Commercial specifications for a new biotherapeutic product are critical component of the product's overall control strategy that ensures safety and efficacy. This paper describes strategies setting commercial as proposed by consortium industry development scientists. The some attributes guided compendia regulatory guidance. For other quality (PQAs), knowledge understanding attribute criticality built throughout should drive specification setting. foundation PQA is an potential patient impact through assessment potency, PK, immunogenicity safety. In addition to knowledge, ability manufacturing process consistently meet specifications, typically assessed statistical analyses, important consideration in specification-setting process. Setting acceptance criteria unnecessarily narrow can supply or prohibit future convenient dosage forms. Patient-centric enable appropriate over higher risk PQAs ensure patient, flexibility lower sustainable chain. captures common strategic approaches standard products such monoclonal antibodies includes considerations ensuring centric.