Understanding the puzzle of 'well-characterized biotechnology products'.
The concept of a 'well-characterized biotechnology product' is akin to assembling a jigsaw puzzle. Each of the analytical pieces must be assembled to provide a clearly, orthogonally defined picture that addresses completely the physicochemical, biological and pharmacological attributes that fully characterize the molecule.
Sadick
Michael
M
Bioproduct Pharmaceutical Development Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. sadickmd@lilly.com
D001681:Biological Assay; D001688:Biological Products; D001702:Biopharmaceutics / Q000379:methods / Q000592:standards; D010600:Pharmacology / Q000379:methods*; D011485:Protein Binding; D011487:Protein Conformation; D011506:Proteins / Q000032:analysis* / Q000737:chemistry*; D011786:Quality Control; D012015:Reference Standards
D001688:Biological Products; D011506:Proteins