PMID- 26138048
OWN - NLM
STAT- MEDLINE
DCOM- 20160816
LR  - 20240109
IS  - 1520-6033 (Electronic)
IS  - 1520-6033 (Linking)
VI  - 31
IP  - 5
DP  - 2015 Sep-Oct
TI  - Efficient high-throughput biological process characterization: Definitive 
      screening design with the ambr250 bioreactor system.
PG  - 1388-95
LID - 10.1002/btpr.2142 [doi]
AB  - The burgeoning pipeline for new biologic drugs has increased the need for 
      high-throughput process characterization to efficiently use process development 
      resources. Breakthroughs in highly automated and parallelized upstream process 
      development have led to technologies such as the 250-mL automated mini bioreactor 
      (ambr250) system. Furthermore, developments in modern design of experiments 
      (DoE) have promoted the use of definitive screening design (DSD) as an efficient 
      method to combine factor screening and characterization. Here we utilize the 
      24-bioreactor ambr250 system with 10-factor DSD to demonstrate a systematic 
      experimental workflow to efficiently characterize an Escherichia coli (E. coli) 
      fermentation process for recombinant protein production. The generated process 
      model is further validated by laboratory-scale experiments and shows how the 
      strategy is useful for quality by design (QbD) approaches to control strategies 
      for late-stage characterization.
CI  - (c) 2015 American Institute of Chemical Engineers.
FAU - Tai, Mitchell
AU  - Tai M
AD  - Biologics Process Development, Bristol-Myers Squibb, Seattle, WA.
FAU - Ly, Amanda
AU  - Ly A
AD  - Biologics Process Development, Bristol-Myers Squibb, Seattle, WA.
FAU - Leung, Inne
AU  - Leung I
AD  - Biologics Process Development, Bristol-Myers Squibb, Seattle, WA.
FAU - Nayar, Gautam
AU  - Nayar G
AD  - Biologics Process Development, Bristol-Myers Squibb, Seattle, WA.
LA  - eng
PT  - Journal Article
DEP - 20150715
PL  - United States
TA  - Biotechnol Prog
JT  - Biotechnology progress
JID - 8506292
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - *Bioreactors
MH  - Escherichia coli/metabolism
MH  - *Fermentation
MH  - High-Throughput Screening Assays/*methods
MH  - Recombinant Proteins/biosynthesis
MH  - Workflow
OTO - NOTNLM
OT  - Escherichia coli fermentation
OT  - ambr250
OT  - definitive screening design
OT  - design of experiment
OT  - high-throughput
OT  - process characterization
OT  - process development
OT  - quality by design
EDAT- 2015/07/04 06:00
MHDA- 2016/08/17 06:00
CRDT- 2015/07/04 06:00
PHST- 2015/03/16 00:00 [received]
PHST- 2015/05/18 00:00 [revised]
PHST- 2015/07/04 06:00 [entrez]
PHST- 2015/07/04 06:00 [pubmed]
PHST- 2016/08/17 06:00 [medline]
AID - 10.1002/btpr.2142 [doi]
PST - ppublish
SO  - Biotechnol Prog. 2015 Sep-Oct;31(5):1388-95. doi: 10.1002/btpr.2142. Epub 2015 
      Jul 15.