Disposition of biologics

Area of Science:

• Biopharmaceutical Development
• Pharmacokinetics and ADME Sciences
• Drug Discovery and Design

Background:

• Drug development involves multidisciplinary expertise, with small molecule development detailed elsewhere.
• This chapter focuses on large molecules, or biologics, and their specific development challenges.
• Biologics are defined here as molecules primarily composed of amino acids, sugars, or nucleotide bases, including chemically modified oligonucleotides and peptides.

Purpose of the Study:

• To delineate the distinct pharmacokinetic and ADME characteristics of biologics versus small molecule drugs.
• To identify complexities and simplifications in biologic drug development processes.
• To examine the influence of biologic pharmacokinetics and ADME on toxicological and pharmacological endpoints.

Main Methods:

• Comparative analysis of pharmacokinetic and ADME principles for biologics and small molecules.
• Review of existing literature and regulatory definitions of biologics.
• Discussion of chemical modifications enhancing drug-like properties of biologics.

Main Results:

• Biologics present unique pharmacokinetic and ADME profiles that differ significantly from small molecules.
• Certain aspects of biologic development may offer unexpected simplifications.
• Understanding these differences is crucial for predicting toxicological and pharmacological effects.

Conclusions:

• The development of biologic drugs requires specialized consideration of their pharmacokinetic and ADME properties.
• A clear definition and understanding of biologics are essential for effective drug development.
• This knowledge impacts safety and efficacy assessments, guiding the development of novel therapeutics.