title: A snapshot of biologic drug development: Challenges and opportunities.
abstract: Since the approval of insulin as the first recombinant therapeutic protein, the prominence of biologic therapies in drug development has grown significantly. Many modalities beyond traditional biologics are now being developed or explored for various indications with significant unmet medical needs. From early traditional replacement proteins to more recent, highly engineered antibodies, oligonucleotides, fusion proteins, and gene constructs, biologic agents have delivered life-changing therapies, despite often having scientifically and technically challenging development programs. This brief review outlines some of the major biotherapeutic classes and identifies the advantages and challenges with the development of these products.
authors.affiliation: Preclinical Safety, AbbVie Research Center, Worcester, MA, USA laura.andrews@abbvie.com.
authors.forename: L
authors.initials: L
authors.lastname: Andrews
authors.affiliation: Preclinical Safety, AbbVie, Lake County, IL, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ralston
authors.affiliation: Comparative and Molecular Toxicology, AbbVie, Lake County, IL, USA.
authors.forename: E
authors.initials: E
authors.lastname: Blomme
authors.affiliation: Department of Pathology, AbbVie, Lake County, IL, USA.
authors.forename: K
authors.initials: K
authors.lastname: Barnhart
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use*; D015316:Genetic Therapy; D006801:Humans; D009696:Nucleic Acids / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D009696:Nucleic Acids
keywords: Biologic drug development; biologics; gene therapy; monoclonal antibody; nucleic acid therapeutics