TY - JOUR
T1 - Shifting Paradigms Revisited
T2 - Biotechnology and the Pharmaceutical Sciences
AU - Crommelin, Daan J A
AU - Mastrobattista, Enrico
AU - Hawe, Andrea
AU - Hoogendoorn, Karin H
AU - Jiskoot, Wim
N1 - Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - protein delivery
KW - immunogenicity
KW - monoclonal antibody(s)
KW - biosimilar(s)
KW - formulation
KW - macromolecular drug delivery
KW - oligonucleotide(s)
KW - gene delivery
U2 - 10.1016/j.xphs.2019.08.010
DO - 10.1016/j.xphs.2019.08.010
M3 - Article
C2 - 31449815
SN - 0022-3549
VL - 109
SP - 30
EP - 43
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
IS - 1
ER -