High concentration formulation developability approaches and considerations

• Main Authors: Jonathan Zarzar (Author), Tarik Khan (Author), Maniraj Bhagawati (Author), Benjamin Weiche (Author), Jasmin Sydow-Andersen (Author), Alavattam Sreedhara (Author)
• Format: Book
• Published: Taylor & Francis Group, 2023-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

ABSTRACTThe growing need for biologics to be administered subcutaneously and ocularly, coupled with certain indications requiring high doses, has resulted in an increase in drug substance (DS) and drug product (DP) protein concentrations. With this increase, more emphasis must be placed on identifyi...