PMID- 30121383
OWN - NLM
STAT- MEDLINE
DCOM- 20190114
LR  - 20190114
IS  - 1876-4347 (Electronic)
IS  - 1871-6784 (Linking)
VI  - 49
DP  - 2019 Mar 25
TI  - Introduction of a process mass intensity metric for biologics.
PG  - 37-42
LID - S1871-6784(18)30225-5 [pii]
LID - 10.1016/j.nbt.2018.07.005 [doi]
AB  - Biopharmaceuticals (or biologics), large molecule therapeutics typically produced 
      using biotechnology, are a rapidly growing segment of the pharmaceutical market. 
      As such, the environmental footprint of the production of these molecules is 
      coming under scrutiny from various stakeholders such as healthcare providers, 
      investors, and even employees. Process mass intensity (PMI), originally adopted 
      for small molecules by the Green Chemistry Institute Pharmaceutical Roundtable, 
      is a simple metric that can also be applied to evaluate the process efficiency of 
      biopharmaceutical production. PMI for biologics is defined as the total mass 
      input in kg of water, raw materials and consumables, required to make 1 kg of 
      active pharmaceutical ingredient. Six large pharmaceutical companies participated 
      in a benchmarking exercise to calculate the PMI for monoclonal antibody (mAb) 
      production. On average, 7700 kg of input is required to produce 1 kg of mAb. Over 
      90% of the mass is due to water use, highlighting the water-intensive nature of 
      biologics production.
CI  - Copyright (c) 2018 Elsevier B.V. All rights reserved.
FAU - Budzinski, Kristi
AU  - Budzinski K
AD  - Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 
      94080, USA. Electronic address: budzinski.kristi@gene.com.
FAU - Blewis, Megan
AU  - Blewis M
AD  - Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
FAU - Dahlin, Philip
AU  - Dahlin P
AD  - Johnson and Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933, USA.
FAU - D'Aquila, Daniel
AU  - D'Aquila D
AD  - GlaxoSmithKline, 709 Swedeland Road, UE3838 King of Prussia, PA 19406, USA.
FAU - Esparza, Julia
AU  - Esparza J
AD  - MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
FAU - Gavin, Jack
AU  - Gavin J
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Ho, Sa V
AU  - Ho SV
AD  - Pfizer Inc., 700 Chesterfield Parkway West, JJ2, Chesterfield, MO, 63017, USA.
FAU - Hutchens, Clarice
AU  - Hutchens C
AD  - Pfizer Inc., 700 Chesterfield Parkway West, JJ2, Chesterfield, MO, 63017, USA.
FAU - Kahn, David
AU  - Kahn D
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
FAU - Koenig, Stefan G
AU  - Koenig SG
AD  - Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 
      94080, USA.
FAU - Kottmeier, Robert
AU  - Kottmeier R
AD  - Pfizer Inc., 700 Chesterfield Parkway West, JJ2, Chesterfield, MO, 63017, USA.
FAU - Millard, Jeff
AU  - Millard J
AD  - MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
FAU - Snyder, Matt
AU  - Snyder M
AD  - CRB, 220 West Germantown Pike, Plymouth Meeting, PA 19462, USA.
FAU - Stanard, Brad
AU  - Stanard B
AD  - MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
FAU - Sun, Lixin
AU  - Sun L
AD  - Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
LA  - eng
PT  - Journal Article
DEP - 20180816
PL  - Netherlands
TA  - N Biotechnol
JT  - New biotechnology
JID - 101465345
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biological Products)
RN  - 059QF0KO0R (Water)
SB  - IM
MH  - Antibodies, Monoclonal/biosynthesis
MH  - Biological Products/*analysis
MH  - Bioreactors
MH  - Biotechnology/*methods
MH  - Molecular Weight
MH  - Water
OTO - NOTNLM
OT  - Biologics
OT  - Metrics
OT  - Monoclonal antibodies
OT  - PMI
OT  - Process efficiency
OT  - Process mass intensity
EDAT- 2018/08/20 06:00
MHDA- 2019/01/15 06:00
CRDT- 2018/08/20 06:00
PHST- 2018/04/11 00:00 [received]
PHST- 2018/07/02 00:00 [revised]
PHST- 2018/07/28 00:00 [accepted]
PHST- 2018/08/20 06:00 [pubmed]
PHST- 2019/01/15 06:00 [medline]
PHST- 2018/08/20 06:00 [entrez]
AID - S1871-6784(18)30225-5 [pii]
AID - 10.1016/j.nbt.2018.07.005 [doi]
PST - ppublish
SO  - N Biotechnol. 2019 Mar 25;49:37-42. doi: 10.1016/j.nbt.2018.07.005. Epub 2018 Aug 
      16.