High-dose monoclonal antibodies via the subcutaneous route: challenges and technical solutions, an industry perspective.
This review summarizes the various challenges in product development involved in subcutaneous administration of high-dose monoclonal antibodies and attempts to provide an industry perspective of some of the available technologies and potential avenues to overcome these challenges.
Sterile Product Development, Merck Research Laboratories, Summit, NJ, USA.
Chakravarthy
C
Narasimhan
Henryk
H
Mach
Mohammed
M
Shameem
D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D055104:Infusions, Subcutaneous; D007279:Injections, Subcutaneous; D036103:Nanotechnology; D011489:Protein Denaturation; D013678:Technology, Pharmaceutical / Q000379:methods; D014783:Viscosity
D000911:Antibodies, Monoclonal