Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences

In 2003, Crommelin et al. published an article titled: “Shifting paradigms: biopharmaceuticals versus low molecular weight drugs” (https://doi.org/10.1016/S0378-5173(03)00376-4). In the present commentary, 16 years later, we discuss pharmaceutically relevant aspects of the evolution of biologics sin...

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical sciences 2020-01, Vol.109 (1), p.30-43
Main Authors: Crommelin, Daan J.A., Mastrobattista, Enrico, Hawe, Andrea, Hoogendoorn, Karin H., Jiskoot, Wim
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - chemistry
Biological Products - administration & dosage
Biological Products - chemical synthesis
Biosimilar Pharmaceuticals - administration & dosage
Biosimilar Pharmaceuticals - chemical synthesis
biosimilar(s)
Biotechnology - methods
Biotechnology - trends
Chemistry, Pharmaceutical - methods
Chemistry, Pharmaceutical - trends
Drug Administration Routes
formulation
gene delivery
Humans
immunogenicity
macromolecular drug delivery
monoclonal antibody(s)
oligonucleotide(s)
protein delivery
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:In 2003, Crommelin et al. published an article titled: “Shifting paradigms: biopharmaceuticals versus low molecular weight drugs” (https://doi.org/10.1016/S0378-5173(03)00376-4). In the present commentary, 16 years later, we discuss pharmaceutically relevant aspects of the evolution of biologics since then. First, we discuss the increasing repertoire of biologics, in particular, the rapidly growing monoclonal antibody family and the advent of advanced therapy medicinal products. Next, we discuss trends in formulation and characterization as well as summarize our current insights into immunogenicity of biologics. We spend a separate section on new product(ion) paradigms for biologics, such as cell-free production systems, production of advanced therapy medicinal products, and downscaled production approaches. Furthermore, we share our views on issues related to reaching the patient, including routes and techniques of administration, alternative development models for affordable biologics, biosimilars, and handling of biologics. In the concluding section, we outline outstanding issues and make some suggestions for resolving those.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2019.08.010