By Honghui Zhou, Frank-Peter Theil
With an emphasis at the basic and useful facets of ADME for healing proteins, this e-book is helping readers strategize, plan and enforce translational learn for biologic drugs.
• Details state-of-the-art ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs
• Combines theoretical with sensible elements of ADME in biologic drug discovery and improvement and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned viewpoint
• Includes case stories approximately leveraging ADME to enhance biologics drug improvement for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines
• Presents regulatory expectancies and views for constructing biologic medicinal drugs in united states, ecu, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion reminiscent of tumors and the brain
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Extra resources for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development
The domain structure of the antibody molecule also lends itself to other engineered formats designed to achieve new modalities, such as bispecificity. Several approaches have been taken to promote heavy‐ chain heterodimer formation, including a “knobs into holes” method  and a method exploiting the phenomenon of Fab‐arm exchange . Other approaches aim to combine IgG with additional smaller antigen‐binding fragments fused to the C‐terminus of heavy or light chain . It is beyond the scope of this chapter to describe in full this plethora of bispecific strategies, but they do serve to highlight the power of protein engineering techniques to create Ig‐based novel molecules to achieve new therapeutic modalities.
These include the Ser‐239 to Asp, Isoleucine (Ile)‐332 to Glu changes that offer significant improvements in ADCC , plus the Ser‐267 to Glu, Histidine (His)‐268 to Ser, Ser‐324 to Thr combination to improve CDC . In addition, since glycosylation at Asn‐297 is critical for Fc structure and effector function, glycoengineering has been undertaken to enhance activity . 1), which have shown success in the clinic and offer even greater future potential. The simplest is the Fab fragment that offers monovalent antigen binding without any Fc‐mediated effector function.
AAPS workshop report: strategies to address therapeutic protein‐drug interactions during clinical develop ment. AAPS J 2011;13:405–416.  Evers R, Dallas S, Dickmann LJ, Fahmi OA, Kenny JR, Kraynov E, Nguyen T, Patel AH, Slatter JG, Zhang L. Critical review of preclinical approaches to investigate cytochrome P450–mediated therapeutic protein drug‐drug interactions and recommendations for best practices: a white paper. Drug Metab Dispos 2013;41:1598–1609.  Machavaram KK, Almond LM, Rostami‐Hodjegan A, Gardner I, Jamei M, Tay S, Wong S, Joshi A, Kenny JR.
ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development by Honghui Zhou, Frank-Peter Theil