PMID- 36368463
OWN - NLM
STAT- MEDLINE
DCOM- 20221216
LR  - 20221221
IS  - 1876-4347 (Electronic)
IS  - 1871-6784 (Linking)
VI  - 72
DP  - 2022 Dec 25
TI  - Comparison of process mass intensity (PMI) of continuous and batch manufacturing 
      processes for biologics.
PG  - 122-127
LID - S1871-6784(22)00061-9 [pii]
LID - 10.1016/j.nbt.2022.11.002 [doi]
AB  - Biologics encompasses a wide variety of therapeutics including monoclonal 
      antibodies, fusion proteins, and enzymes, among others. The biologics market is 
      growing at a rapid pace and different manufacturing processes, including 
      continuous manufacturing processes, are being increasingly adopted. There is a 
      strong drive to assess the sustainability of such processes. Here, we calculated 
      the process mass intensity (PMI) of a continuous manufacturing process and 
      compared it to the PMI of batch processes for monoclonal antibodies (mAbs). 
      Results show that the PMI of continuous manufacturing process is comparable to 
      that of batch processes. Sensitivity analysis was performed to assess the impact 
      of different process strategies on the material usage efficiency of continuous 
      processes. Although PMI is a useful benchmarking metric of sustainability, it 
      does not account for factors such as energy consumption which is a key driver of 
      sustainability for biologics manufacturing. Comparison of a higher PMI continuous 
      process with a lower PMI batch process operating at the same bioreactor scale 
      shows that since the productivity (in g of drug substance, DS) per unit time is 
      multifold higher for the continuous process, the overall energy consumption per 
      unit of DS produced might be lower leading to a more environmentally sustainable 
      process. This study highlights some of these key aspects that would require 
      additional metrics and models to be developed to assess the overall 
      sustainability of biologics processes.
CI  - Copyright (c) 2022. Published by Elsevier B.V.
FAU - Madabhushi, Sri R
AU  - Madabhushi SR
AD  - Biologics Process Research and Development, Merck & Co., Inc., 2000 Galloping 
      Hill Road, Kenilworth, NJ 07033, USA. Electronic address: 
      sri.madabhushi@merck.com.
FAU - Pinto, Nuno D S
AU  - Pinto NDS
AD  - Biologics Process Research and Development, Merck & Co., Inc., 2000 Galloping 
      Hill Road, Kenilworth, NJ 07033, USA.
FAU - Lin, Henry
AU  - Lin H
AD  - Biologics Process Research and Development, Merck & Co., Inc., 2000 Galloping 
      Hill Road, Kenilworth, NJ 07033, USA.
LA  - eng
PT  - Journal Article
DEP - 20221108
PL  - Netherlands
TA  - N Biotechnol
JT  - New biotechnology
JID - 101465345
RN  - 0 (Biological Products)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - *Biological Products
MH  - Bioreactors
MH  - Antibodies, Monoclonal
OTO - NOTNLM
OT  - Biologics
OT  - Continuous manufacturing process
OT  - Process mass intensity
OT  - Sustainability
COIS- Conflict of interest The authors declare that there are no conflicts of 
      interests.
EDAT- 2022/11/12 06:00
MHDA- 2022/12/15 06:00
CRDT- 2022/11/11 19:24
PHST- 2022/07/11 00:00 [received]
PHST- 2022/11/04 00:00 [revised]
PHST- 2022/11/06 00:00 [accepted]
PHST- 2022/11/12 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/11/11 19:24 [entrez]
AID - S1871-6784(22)00061-9 [pii]
AID - 10.1016/j.nbt.2022.11.002 [doi]
PST - ppublish
SO  - N Biotechnol. 2022 Dec 25;72:122-127. doi: 10.1016/j.nbt.2022.11.002. Epub 2022 
      Nov 8.