The development of biologics, including therapeutic proteins, peptides, monoclonal antibodies, nucleic acid therapeutics, gene-based medicines, RNA therapeutics, and cell-derived products, has expanded the therapeutic landscape beyond conventional small-molecule drugs. However, these agents frequently face substantial delivery challenges due to their large molecular size, structural complexity, instability within biological environments, and limited ability to cross physiological barriers. Recent advances in pharmaceutical sciences have generated numerous technologies designed to improve the bioavailability and permeability of these therapeutics while enhancing their pharmacological performance. Although many promising approaches have been reported, significant challenges remain in understanding their mechanisms of action, interactions with biological systems, effects on target engagement, pharmacokinetic profiles, biodistribution, safety, and long-term translational potential. Experimental pharmacology plays a critical role in establishing the mechanistic foundations necessary for successful clinical translation.
Biologics and advanced therapeutics have transformed modern drug discovery by enabling highly specific treatment approaches for a wide range of diseases, including cancer, inflammatory disorders, infectious diseases, genetic conditions, and rare diseases. Despite their remarkable therapeutic potential, the successful translation of these agents is often hindered by multiple biological and pharmacological barriers, including poor membrane permeability, limited oral bioavailability, rapid enzymatic degradation, unfavorable pharmacokinetics, insufficient tissue penetration, and inadequate intracellular delivery. To overcome these limitations, a wide range of innovative delivery and formulation technologies have been developed. These include nanocarrier systems, molecular engineering approaches, permeation enhancers, cell-penetrating peptides, biomimetic delivery systems, extracellular vesicles, microneedle platforms, long-acting formulations, advanced administration devices, and other enabling technologies designed to improve therapeutic performance. This Research Topic aims to provide a comprehensive platform for advancing the experimental pharmacology of technologies that improve the delivery, efficacy, safety, and translational potential of biologics and advanced therapeutics. Particular emphasis will be placed on mechanistic understanding, biological target engagement, pharmacokinetic behavior, pharmacodynamic outcomes, and safety evaluation.
This Research Topic welcomes contributions investigating innovative technologies that enhance the delivery and pharmacological performance of biologics and advanced therapeutics. Submissions should provide mechanistic and experimental pharmacological insights rather than focusing solely on formulation development. Topics of interest include, but are not limited to: • Nanocarrier-based delivery systems for biologics and advanced therapeutics • Permeation enhancement technologies and biological barrier modulation • Protein, peptide, and antibody engineering approaches to improve delivery • Cell-penetrating peptides and intracellular delivery technologies • Biomimetic carriers, extracellular vesicles, and exosome-based delivery systems • Microneedle, implantable, injectable, intranasal, pulmonary, and oral delivery technologies • Long-acting and controlled-release systems • Drug-device combination technologies • Pharmacokinetics, biodistribution, metabolism, immunogenicity, and toxicological assessment • Mechanistic studies of biological target engagement and therapeutic efficacy • Translational challenges associated with advanced therapeutic delivery This Research Topic invites Original Research Articles, Reviews, Mini-Reviews, Methods, Perspectives, and Systematic Reviews that contribute to the development and experimental pharmacological evaluation of technologies designed to overcome delivery barriers and improve therapeutic outcomes of biologics and advanced therapeutics.
Drug–target interaction emphasis must be explicit - The experimental pharmacology section requires 'detailed, in-depth knowledge about the interaction between drugs and specific biological targets'. The current scope text leans toward delivery technology in the abstract — add wording that contributions must characterize how the delivery system modulates drug–target engagement (receptor, enzyme, transporter, ion channel, transcription factor).
Exclude in-silico-only and clinical-trial-only submissions: The section excludes purely in-silico studies and clinical trials. The 'Scope and information for authors' paragraph should add something like: 'Studies based solely on in silico predictions, clinical trial outcomes without experimental pharmacology, or formulation development without mechanistic readouts are out of scope.'
Article types and fees
This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:
Brief Research Report
Case Report
Clinical Trial
Community Case Study
Data Report
Editorial
FAIR² Data
General Commentary
Hypothesis and Theory
Articles that are accepted for publication by our external editors following rigorous peer review incur a publishing fee charged to Authors, institutions, or funders.
Article types
This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:
Brief Research Report
Case Report
Clinical Trial
Community Case Study
Data Report
Editorial
FAIR² Data
General Commentary
Hypothesis and Theory
Methods
Mini Review
Opinion
Original Research
Perspective
Policy and Practice Reviews
Policy Brief
Review
Study Protocol
Systematic Review
Technology and Code
Keywords: Biologics, Advanced Therapeutics, Drug Delivery Technologies, Bioavailability Enhancement, Permeability Enhancement, Experimental Pharmacology, Pharmacokinetics, Biopharmaceuticals, Targeted Delivery, Drug Discovery
Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.