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.
Bioproduct Pharmaceutical Development Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. sadickmd@lilly.com
Michael
M
Sadick
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