By Honghui Zhou, Frank-Peter Theil
With an emphasis at the primary and functional features of ADME for healing proteins, this ebook 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 features of ADME in biologic drug discovery and improvement and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned point of view
• 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, european, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion akin to tumors and the brain
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Additional info for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development
38] European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins; 2005 July.  Tang C, Prueksaritanont T. Theoretical analysis of interplay of therapeutic protein rug and circulating soluble target: temporal profiles of ‘free’ and ‘total’ drug and target. Pharm Res 2011;28:2447–2457.  Ezan E, Dubois M, Becher F. Bioanalysis of recombinant proteins and antibodies by mass spectrometry.
The consensus site is asparagine‐X‐threonine/serine (Asn‐X‐Thr/Ser), where X can be any amino acid other than Pro, so mutation of either the Asn or the Thr/Ser residue can be used to successfully ablate the site. Occasionally, V‐region carbohydrate moieties can be involved in antigen binding, so affinity will need to be assessed after mutation. During the humanization of the antibody 5/44, which became the antibody element of inotuzumab ozogamicin, a glycosylation site within heavy‐chain CDR2 was ablated by changing the Thr to Ala .
Similarly, free cysteine (Cys) sulfydryl can be oxidized to form Cys disulfide bonds, depending on the local environment. The presence of single unpaired Cys residues in CDRs is usually undesirable and replacement can be considered (often with Ser). N‐terminal glutamine (Gln) residues, frequently found on heavy chains, are liable to cyclize to form pyroglutamate, by the free NH2 group reacting with the side chain . This occurs naturally in antibodies but the reaction may not go to completion and any heterogeneity in preparations of recombinant antibodies is undesirable.