PMID- 28795201
OWN - NLM
STAT- MEDLINE
DCOM- 20190506
LR  - 20231117
IS  - 0724-6145 (Print)
IS  - 0724-6145 (Linking)
VI  - 165
DP  - 2018
TI  - Downstream Processing Technologies/Capturing and Final Purification : 
      Opportunities for Innovation, Change, and Improvement. A Review of Downstream 
      Processing Developments in Protein Purification.
PG  - 115-178
LID - 10.1007/10_2017_12 [doi]
AB  - Increased pressure on upstream processes to maximize productivity has been 
      crowned with great success, although at the cost of shifting the bottleneck to 
      purification. As drivers were economical, focus is on now on debottlenecking 
      downstream processes as the main drivers of high manufacturing cost. Devising a 
      holistically efficient and economical process remains a key challenge. 
      Traditional and emerging protein purification strategies with particular emphasis 
      on methodologies implemented for the production of recombinant proteins of 
      biopharmaceutical importance are reviewed. The breadth of innovation is 
      addressed, as well as the challenges the industry faces today, with an eye to 
      remaining impartial, fair, and balanced. In addition, the scope encompasses both 
      chromatographic and non-chromatographic separations directed at the purification 
      of proteins, with a strong emphasis on antibodies. Complete solutions such as 
      integrated USP/DSP strategies (i.e., continuous processing) are discussed as well 
      as gains in data quantity and quality arising from automation and high-throughput 
      screening (HTS). Best practices and advantages through design of experiments 
      (DOE) to access a complex design space such as multi-modal chromatography are 
      reviewed with an outlook on potential future trends. A discussion of single-use 
      technology, its impact and opportunities for further growth, and the exciting 
      developments in modeling and simulation of DSP rounds out the overview. Lastly, 
      emerging trends such as 3D printing and nanotechnology are covered. Graphical 
      Abstract Workflow of high-throughput screening, design of experiments, and 
      high-throughput analytics to understand design space and design space boundaries 
      quickly. (Reproduced with permission from Gregory Barker, Process Development, 
      Bristol-Myers Squibb).
FAU - Singh, Nripen
AU  - Singh N
AD  - Bristol-Myers Squibb, Global Manufacturing and Supply, Devens, MA, 01434, USA. 
      nripen.singh@bms.com.
FAU - Herzer, Sibylle
AU  - Herzer S
AD  - Bristol-Myers Squibb, Global Manufacturing and Supply, Hopewell, NJ, 01434, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - Germany
TA  - Adv Biochem Eng Biotechnol
JT  - Advances in biochemical engineering/biotechnology
JID - 8307733
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Automation
MH  - *Biotechnology/trends
MH  - Chromatography, Affinity
MH  - *Recombinant Proteins/isolation & purification
OTO - NOTNLM
OT  - Bioprocessing
OT  - Downstream
OT  - High-throughput processing
OT  - Modeling
OT  - Process improvements
OT  - Purification
EDAT- 2017/08/11 06:00
MHDA- 2019/05/07 06:00
CRDT- 2017/08/11 06:00
PHST- 2017/08/11 06:00 [pubmed]
PHST- 2019/05/07 06:00 [medline]
PHST- 2017/08/11 06:00 [entrez]
AID - 10.1007/10_2017_12 [doi]
PST - ppublish
SO  - Adv Biochem Eng Biotechnol. 2018;165:115-178. doi: 10.1007/10_2017_12.