IMPLEMENTATION OF STANDARDS TO SUPPORT FIT-FOR-PURPOSE ANALYTICAL DEVELOPMENT FOR THE CHARACTERIZATION AND TESTING OF CELLULAR THERAPEUTIC PRODUCTS

被引:0
|
作者
Sarkar, S. [1 ]
Pierce, L. [1 ]
机构
[1] NIST, Biosyst & Biomat Devis, Gaithersburg, MD USA
关键词
analytical methods; Quality Attributes; Standards;
D O I
暂无
中图分类号
Q813 [细胞工程];
学科分类号
摘要
878
引用
收藏
页码:S200 / S201
页数:2
相关论文
共 6 条
  • [1] Fit-for-purpose wastewater treatment: Testing to implementation of decision support tool (II)
    Chhipi-Shrestha, Gyan
    Hewage, Kasun
    Sadiq, Rehan
    [J]. SCIENCE OF THE TOTAL ENVIRONMENT, 2017, 607 : 403 - 412
  • [2] DEVELOPMENT OF A FIT-FOR-PURPOSE TOBACCO AND NICOTINE PRODUCTS DEPENDENCE INSTRUMENT
    Chrea, C.
    Salzberger, T.
    Abetz-Webb, L.
    Afolalu, E. F.
    Cano, S.
    Rose, J.
    Weitkunat, R.
    Fagerstrom, K.
    [J]. VALUE IN HEALTH, 2018, 21 : S387 - S387
  • [3] Fit-for-purpose wastewater treatment: Conceptualization to development of decision support tool (I)
    Chhipi-Shrestha, Gyan
    Hewage, Kasun
    Sadiq, Rehan
    [J]. SCIENCE OF THE TOTAL ENVIRONMENT, 2017, 607 : 600 - 612
  • [4] A generic bioanalytical method development strategy and fit-for-purpose qualification to support hERG in vitro sample analysis
    Holme, Paul
    Payne, Kirsty
    Smith, Sonia
    Spence, Mike
    [J]. BIOANALYSIS, 2011, 3 (24) : 2739 - 2745
  • [5] Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs
    Liu, Rong
    Pillutla, Renuka
    DeSilva, Binodh
    Zhang, Yan J.
    [J]. BIOANALYSIS, 2013, 5 (14) : 1751 - 1763
  • [6] "Fit-for-purpose" development of analytical and (semi)preparative enantioselective high performance liquid and supercritical fluid chromatography for the access to a novel σ1 receptor agonist
    Rossi, Daniela
    Marra, Annamaria
    Rui, Marta
    Brambilla, Stefania
    Juza, Markus
    Collina, Simona
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2016, 118 : 363 - 369