Understanding the puzzle of 'well-characterized biotechnology products'

被引:2
|
作者
Sadick, M [1 ]
机构
[1] Eli Lilly & Co, Bioprod Pharmaceut Dev, Indianapolis, IN 46285 USA
关键词
D O I
10.1016/S0958-1669(02)00320-8
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
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.
引用
收藏
页码:275 / 278
页数:4
相关论文
共 50 条
  • [31] Current trends: Impact of the well-characterized regulatory paradigm
    Little, L
    BIOPHARM-THE TECHNOLOGY & BUSINESS OF BIOPHARMACEUTICALS, 1997, 10 (08): : 8 - &
  • [32] STUDIES WITH A WELL-CHARACTERIZED ACOUSTIC-EMISSION SYSTEM
    SACHSE, W
    MATERIALS EVALUATION, 1979, 37 (07) : 62 - 62
  • [33] A Standardized and Well-Characterized hMSC Source for Translational Researchers
    Lock, L.
    Farrance, I.
    Baraniak, P.
    Hao, J.
    Rowley, J.
    TISSUE ENGINEERING PART A, 2014, 20 : S61 - S62
  • [34] WELL-CHARACTERIZED OLEFIN METATHESIS CATALYSTS THAT CONTAIN MOLYBDENUM
    MURDZEK, JS
    SCHROCK, RR
    ORGANOMETALLICS, 1987, 6 (06) : 1373 - 1374
  • [35] Uniaxial extensional rheology of well-characterized comb polymers
    Lentzakis, H.
    Vlassopoulos, D.
    Read, D. J.
    Lee, H.
    Chang, T.
    Driva, P.
    Hadjichristidis, N.
    JOURNAL OF RHEOLOGY, 2013, 57 (02) : 605 - 625
  • [36] DICYCLOPENTADIENE POLYMERIZATION UTILIZING WELL-CHARACTERIZED TUNGSTEN COMPLEXES
    BELL, A
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1991, 201 : 57 - PMSE
  • [37] REACTION OF SMALL MOLECULES AT WELL-CHARACTERIZED IRON SURFACES
    BERNASEK, SL
    ANNUAL REVIEW OF PHYSICAL CHEMISTRY, 1993, 44 (01) : 265 - 298
  • [38] WELL-CHARACTERIZED MONODISPERSE POLYSTYRENE LATEXES AS MODEL COLLOIDS
    VANDERHOFF, JW
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1980, 179 (MAR): : 7 - ORPL
  • [39] Understanding Botanical Dietary Supplements: The Research Need for Well-Characterized Test Materials - Research Grade Botanicals
    Miller, J. S.
    PLANTA MEDICA, 2009, 75 (04) : 406 - 406
  • [40] The α-Enolase of Streptococcus suis: A Previously Well-Known and Well-Characterized Protein
    Gottschalk, Marcelo
    Dubreuil, J. Daniel
    Esgleas, Miriam
    Harel, Josee
    Segura, Mariela
    JOURNAL OF INFECTIOUS DISEASES, 2010, 201 (11): : 1775 - U1