Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

• Main Authors: Patanachai K. Limpikirati (Author), Sorrayut Mongkoltipparat (Author), Thinnaphat Denchaipradit (Author), Nathathai Siwasophonpong (Author), Wudthipong Pornnopparat (Author), Parawan Ramanandana (Author), Phumrapee Pianpaktr (Author), Songsak Tongchusak (Author), Maoxin Tim Tian (Author), Trairak Pisitkun (Author)
• Format: Book
• Published: Elsevier, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

In this review, we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance. Pharmaceutical specifications comprise a lis...