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<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100562</div>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100564</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Concepcion “Conchita” Jimenez-Gonzalez, Claire Lund</div>
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<p>This short review presents an overview of key metrics that have been used to assess the ‘greenness’ of pharmaceutical processes in development in the larger context of environmental sustainability. The green metrics
cover areas of resource efficiency (mass and energy), environment, health, and safety considerations, and life cycle assessment. There is also a discussion of currently unmet needs in the area that need enhanced focus.
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<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100569</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Roger A. Sheldon, Moira L. Bode, Stephanie G. Akakios</div>
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<p>The increasingly apparent negative impact of human activities on the environment has heightened the urgency for the chemistry community to adopt greener and more sustainable practices. The E-factor can still be
considered a valuable tool in this drive, particularly because of its broad acceptance and familiarity amongst both industrial and academic chemists. An important factor in broadening the adoption of green principles is
ensuring that the academics responsible for training the next generation of chemists prioritise green and sustainable practices in their undergraduate and post graduate laboratories. Green metrics must be easy to use to
motivate the broader chemistry community to develop greener syntheses. For maximum impact to be achieved the detail of the exact green metrics applied are less important than their adoption by the broader chemical
community. Of growing importance is the replacement of fossil resources with renewable alternatives to reduce greenhouse gas emission that is a significant driver of climate change. The C factor is used to compare the
carbon footprints of different routes to a particular product.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100571</div>
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<p>Synthetic chemistry relies heavily on organic solvents which are often toxic and hazardous as well as expensive in purchase and disposal. The application of water as an alternative reaction medium is not only
advantageous from an environmental and safety perspective but can also offer improved selectivity and reaction rates. The exploration of this new, sustainable approach comes along with an ever-growing spectrum of
reaction procedures. In this current opinion, we provide an overview of a new methodology that uses a polymeric cellulose derivative, hydroxypropyl methylcellulose, to enable chemical reactions in water.</p>
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environmental impact</span></label></div>
<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100583</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Fabrice Robvieux, Jocelyn Roth, Christian Chapuis, Maud Reiter</div>
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<p>In response to demands for more transparency on the impact of its fragrance products on both people and the planet, Firmenich developed a new, holistic digital assessment tool, EcoScent Compass™, to rank both perfumery
ingredients and perfumery formulations in terms of green chemistry as well as environmental footprint criteria. Using knowledge gathered in the field of green and sustainable chemistry over the past 20 years,
multi-indicator clusters have been deployed and combined into a single index for green properties and environmental impact.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2021.100586</div>
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<a class="anchor article-content-title u-margin-xs-top u-margin-s-bottom anchor-default" href="/science/article/pii/S2452223621001425" id="S2452223621001425" usagezone="rslt_list_item"><span class="anchor-text"><span class="js-article-title">Defossilization of pharmaceutical manufacturing</span></span></a>
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<div class="text-s u-clr-grey8 js-article__item__authors">Lea Wollensack, Kristi Budzinski, Jan Backmann</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">February 2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100586</dd>
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<p>As is true with most established industries, a significant portion of the raw materials used in the pharmaceutical industry is of fossil origin, that is, essentially can be traced back to crude oil. The present article
attempts to assess to which degree the modern manufacturing of pharmaceuticals depends on raw materials of fossil carbon compounds and which could be appropriate ways to increasingly switch to non-fossil sourcing to
eventually completely defossilize the raw-material base of the sector.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2022.100591</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Chihui An, Kevin M. Maloney</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">April 2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100591</dd>
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<p>Cascade reactions have been widely recognized to cut costs, decrease solvent usage, and reduce cycle times in chemical processes. Recently, biocatalytic cascades have altered how we design synthetic routes to complex
molecules to achieve sustainable commercial processes for pharmaceutical, agricultural, and fine chemical industries. With advancements in protein engineering and an increase in the number of enzyme classes available to
chemists, industrial and academic groups alike have endeavored to expand the scope of biocatalysis from single reactions to multi-enzyme cascades to rapidly build complex molecular structures. Recent reports have drawn
inspiration from biosynthetic pathways and have applied engineered enzymes to <em>in vitro</em> enzymatic cascades. Furthermore, combining transition-metal catalysis and enzymes in one-pot chemoenzymatic cascades
likewise serves to broaden the scope of biocatalysis, enabling traditional chemical reactions to be performed under mild aqueous conditions. In this article, we review recent biocatalytic and chemoenzymatic cascades from
2019 to 2021.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2022.100606</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">John L. Tucker</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">June 2022</dd>
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<p>Green chemistry (GC) metrics provide insight into the relative waste, time and cost implications of pharmaceutical chemical processes and serve to guide scientists in the strategic application of resources to develop
more efficient and sustainable processes. Examples of the application of GC metrics in evaluating pharmaceutical process efficiency and the subsequent development toward improvement exist in abundance from journals such
as <em>Organic Process Research and Development</em>, <em>Green Chemistry</em>, or as encompassed by the winning examples from the ACS GCI Pharmaceutical Roundtable's [1] Peter J. Dunn award [2] or the US EPA's Green
Chemistry Challenge award [3]. By their nature, GC metrics are continuously evolving but justify the necessary, unceasing investment in understanding and application as they offer unique, opportunistic insight serving to
guide scientific resource deployment when developing greener pharmaceutical, chemical processes.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2022.100614</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Sarah Argoud, Kristi Budzinski, Daniel D'Aquila, Sri R. Madabhushi, Phillip Smith</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">June 2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100614</dd>
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<p>Biologics are the fastest growing segment of the pharmaceutical market, therefore, the environmental impact of manufacturing these drugs needs to be fully characterized. For monoclonal antibodies, in particular, several
metrics have been identified as the manufacturing process is quite standardized for batch processes. This paper will provide an overview of carbon footprint analysis, process mass intensity (PMI), water related impact of
energy (WARIEN) and life cycle assessment (LCA) as they have been applied to monoclonal antibody production. Further development and standardization of these tools will allow the industry to identify and implement new
technologies that significantly lower the environmental impact of not only monoclonal antibody production but other modalities as well.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2022.100643</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Michael E. Kopach, Benjamin I. Andrews</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">October 2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100643</dd>
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<p>This review article highlights the need for the development of synthetic peptide and oligonucleotide manufacturing processes with improved sustainability credentials. These therapeutic classes are fast growing and have
the potential to deliver multiple high volume products over the next decade. While there have been significant technical innovations in the past few years there is limited evidence for adoption of these new technologies
in manufacturing, which still largely rely on traditional approaches that generate large quantities of waste and use many chemicals of concern. Examples of strategies that could improve the environmental footprint for
peptides include Tag-Assisted Liquid-Phase Peptide Synthesis, Hybrid Solid/Liquid Phase Peptide Synthesis and the implementation of continuous processes. For oligonucleotides, convergent liquid-phase synthesis and
enzyme-catalyzed synthesis strategies are highlighted which have potential for significant positive environmental improvement if incorporated into the development lifecycle. To guide development, the collection of
baseline sustainability metrics such as Process Mass Intensity is recommended.</p>
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<div hidden="">https://doi.org/10.1016/j.cogsc.2022.100689</div>
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<dd class="article-info text-xs"><span class="js-article-subtype">Review article</span><span class="js-open-access"><span class="js-access-indicator u-margin-xs-hor access-indicator-no"></span>Abstract only</span></dd>
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<a class="anchor article-content-title u-margin-xs-top u-margin-s-bottom anchor-default" href="/science/article/pii/S2452223622001018" id="S2452223622001018" usagezone="rslt_list_item"><span class="anchor-text"><span class="js-article-title">Assessment of analytical testing: The impact of metrics for the sustainable measurement of pharmaceuticals</span></span></a>
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<div class="text-s u-clr-grey8 js-article__item__authors">Michael B. Hicks, Sean Oriana, Yong Liu</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">December 2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100689</dd>
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<p>Analytical metrics allow a periodic, healthy examination of methods and how they impact the environment, while ensuring that procedures are reproducible, reliable, repeatable, transferable, and of high quality. This
article provides a review of current trends with analytical metrics, such as the analytical method green score (AMGS). More importantly, the AMGS impact on sample preparation, development strategy, and energy consumption
considerations are provided. Finally, recent uses of metrics with specific relevance to the pharmaceutical research and development area through method transfer are covered.</p>
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<div hidden="">https://doi.org/10.1016/j.crgsc.2021.100222</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Summer Lingard Smith, Diane B. Raynes, Karen L. Howard</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100222</dd>
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<p>GAO conducted a technology assessment to explore among other things, the opportunities, challenges, and stakeholder roles in sustainable chemistry. We found that stakeholders across industry, government, and academia
lack agreement on how to define sustainable chemistry and how to measure or assess the sustainability of chemical processes and products. These differences hinder the development and adoption of more sustainable
chemistry technologies. However, based on a review of the literature and stakeholder interviews, GAO identified several common themes underlying what sustainable chemistry strives to achieve – including that standard
definitions and metrics for sustainability are important for stakeholders. In addition, we note that national leadership and collaboration across many sectors could enhance sustainable chemistry progress. This includes
the potential for sustainable chemistry to inspire new products and processes, create jobs, and enhance benefits to human health and the environment. However, we found that technological and business challenges interfere
with efforts to implement some of these sustainable chemistry technologies, and that the diverse set of stakeholders can lead to coordination challenges. We offer strategic approaches that may help overcome these
challenges.</p>
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<div hidden="">https://doi.org/10.1016/j.crgsc.2021.100229</div>
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<a class="anchor article-content-title u-margin-xs-top u-margin-s-bottom anchor-default" href="/science/article/pii/S2666086521001764" id="S2666086521001764" usagezone="rslt_list_item"><span class="anchor-text"><span class="js-article-title">Manufacturing mass intensity: 15 Years of Process Mass Intensity and development of the metric into plant cleaning and beyond</span></span></a>
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<div class="text-s u-clr-grey8 js-article__item__authors">Colin H. Benison, Philippa R. Payne</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100229</dd>
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<p>The American Chemical Society Green Chemistry Institute (ACS GCI) Pharmaceutical Roundtable is committed to continue to expand and identify elements of small-molecule active pharmaceutical ingredient (API) manufacturing
that should be quantified to drive towards more sustainable practices. Process mass intensity (PMI) has been used for over 15 years to evaluate and benchmark progress towards more sustainable manufacturing and quantifies
process input mass (e.g. solvent, water, reagents) per mass of output produced. This manuscript introduces Manufacturing Mass Intensity (MMI), a metric that builds upon and expands the scope to account for other raw
materials required for API manufacturing. Examples are included to illustrate how quantification of these additional resource requirements will drive more sustainable practices.</p>
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<div hidden="">https://doi.org/10.1016/j.crgsc.2021.100242</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Kristi Budzinski, Stefan G. Koenig</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100242</dd>
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<div hidden="">https://doi.org/10.1016/j.crgsc.2021.100247</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Louis J. Diorazio, Alex Mullen</div>
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<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100247</dd>
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<div hidden="">https://doi.org/10.1016/j.crgsc.2022.100279</div>
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<div class="text-s u-clr-grey8 js-article__item__authors">Mark S. Kerr, Kevin P. Cole</div>
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<dd class="js-article-page-range u-clr-grey8 text-s">Article 100279</dd>
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<p>Continuous processing is now commonly used in the manufacturing of fine chemicals including agrochemicals and pharmaceuticals. Datasets are now available, including some on environmental sustainability aspects, that
enable more direct comparison between related batch and flow processes. This article examines six continuous processes where an environmental sustainability concept or metric (e.g. process mass intensity) can be compared
to that from a closely-related batch process in order to assess the impact that continuous manufacturing has on that theme. Some current case studies where additional Green Chemistry concepts are exemplified are shared
along with how continuous processing impacts the manufacture. We illustrate situations where continuous processing can reasonably be expected to show sustainability advantages over batch, as well as a scenario where
increased solvent usage in flow mode worsened the environmental profile. While we believe that continuous processing can provide sustainability benefits, there are cases where its application can have a negative effect
on environmental metrics. Our hope is to provide impartial guidance for development and manufacturing scientists so they may best utilize continuous technologies in an environmentally responsible way.</p>
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class="checkbox-label-value checkbox-small move-left u-show-from-md">select article Roche's approach to green metrics in drug development</span></label></div>
<div hidden="">https://doi.org/10.1016/j.crgsc.2022.100293</div>
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<dd class="article-info text-xs"><span class="js-article-subtype">Research article</span><span class="js-open-access u-text-italic"><span class="js-access-indicator u-margin-xs-hor access-indicator-yes"></span>Open access</span></dd>
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<a class="anchor article-content-title u-margin-xs-top u-margin-s-bottom anchor-default" href="/science/article/pii/S2666086522000352" id="S2666086522000352" usagezone="rslt_list_item"><span class="anchor-text"><span class="js-article-title">Roche's approach to green metrics in drug development</span></span></a>
</h3>
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<dd class="js-article-author-list u-clr-grey8 text-s">
<div class="text-s u-clr-grey8 js-article__item__authors">Georg Wuitschik, Martin Olbrich, Stefan Hildbrand</div>
</dd>
<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100293</dd>
<dd class="js-article-link u-margin-xs-top u-margin-s-bottom article-item-link">
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<p>This article describes standard, often used metrics and more recent developments. Efforts and possibilities on how to apply them in drug development are shown on the example of Roche.</p>
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class="checkbox-label-value checkbox-small move-left u-show-from-md">select article Green and sustainable metrics: Charting the course for green-by-design small molecule API synthesis</span></label></div>
<div hidden="">https://doi.org/10.1016/j.crgsc.2022.100324</div>
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<a class="anchor article-content-title u-margin-xs-top u-margin-s-bottom anchor-default" href="/science/article/pii/S2666086522000662" id="S2666086522000662" usagezone="rslt_list_item"><span class="anchor-text"><span class="js-article-title">Green and sustainable metrics: Charting the course for green-by-design small molecule API synthesis</span></span></a>
</h3>
</dt>
<dd class="js-article-author-list u-clr-grey8 text-s">
<div class="text-s u-clr-grey8 js-article__item__authors">Harrison B. Rose, Birgit Kosjek, Brittany M. Armstrong, Sandra A. Robaire</div>
</dd>
<dd class="u-clr-grey8 text-s js-article-item-date">2022</dd>
<dd class="js-article-page-range u-clr-grey8 text-s">Article 100324</dd>
<dd class="js-article-link u-margin-xs-top u-margin-s-bottom article-item-link">
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<p>Sustainable small molecule Active Pharmaceutical Ingredient (API) manufacturing starts at the onset of route development by employing a Green-by-Design strategy. Reliable metrics are imperative for setting targets and
measuring process improvements throughout the development cycle. This article reviews some of the many tools and methods established to analyze and assess the greenness and sustainability of a process, each of which
highlights different aspects of process efficiency, waste formation or overall environmental impact reduction. Most calculations, such as process mass intensity (PMI), are mass-based and do not consider the types of raw
materials used. In contrast, a full life cycle assessment (LCA) offers detailed information about the “cradle to grave” environmental impact of a manufacturing route and its specific resources, but the high data
requirements and long timelines are not conducive for multiple processes or repeated assessments during process optimization. To address these challenges, we introduce a Streamlined PMI-LCA Tool, developed in
collaboration with the ACS Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR), that combines PMI with a “cradle to gate” approach to include the environmental footprint of the synthesis’ raw materials. The
frequent re-evaluation of a process continuously highlights areas for improvement and guides the prioritization of process development activities to effectively and rapidly achieve a Green-by-Design commercial synthetic
route. The utility of this approach to Green-by-Design is demonstrated with the reduction of PMI for MK-7264 from 366 to 88 over the course of process development.</p>
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CURRENT OPINION IN GREEN AND SUSTAINABLE CHEMISTRY
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METRICS FOR GREEN CHEMISTRY (2022)
Edited by Frank Roschangar, Fabrice Gallou
LAST UPDATE 5 JANUARY 2022
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1. select article Green chemistry and sustainability metrics in the
pharmaceutical manufacturing sector
https://doi.org/10.1016/j.cogsc.2021.100562
Review articleAbstract only
GREEN CHEMISTRY AND SUSTAINABILITY METRICS IN THE PHARMACEUTICAL
MANUFACTURING SECTOR
Jochen Becker, Carolin Manske, Stefan Randl
February 2022Article 100562Purchase PDF
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* Abstract
* Graphical abstract
GRAPHICAL ABSTRACT
2. select article Green metrics in pharmaceutical development
https://doi.org/10.1016/j.cogsc.2021.100564
Review articleAbstract only
GREEN METRICS IN PHARMACEUTICAL DEVELOPMENT
Concepcion “Conchita” Jimenez-Gonzalez, Claire Lund
February 2022Article 100564Purchase PDF
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* Abstract
This short review presents an overview of key metrics that have been used
to assess the ‘greenness’ of pharmaceutical processes in development in the
larger context of environmental sustainability. The green metrics cover
areas of resource efficiency (mass and energy), environment, health, and
safety considerations, and life cycle assessment. There is also a
discussion of currently unmet needs in the area that need enhanced focus.
3. select article Metrics of green chemistry: Waste minimization
https://doi.org/10.1016/j.cogsc.2021.100569
Review articleAbstract only
METRICS OF GREEN CHEMISTRY: WASTE MINIMIZATION
Roger A. Sheldon, Moira L. Bode, Stephanie G. Akakios
February 2022Article 100569Purchase PDF
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* Abstract
The increasingly apparent negative impact of human activities on the
environment has heightened the urgency for the chemistry community to adopt
greener and more sustainable practices. The E-factor can still be
considered a valuable tool in this drive, particularly because of its broad
acceptance and familiarity amongst both industrial and academic chemists.
An important factor in broadening the adoption of green principles is
ensuring that the academics responsible for training the next generation of
chemists prioritise green and sustainable practices in their undergraduate
and post graduate laboratories. Green metrics must be easy to use to
motivate the broader chemistry community to develop greener syntheses. For
maximum impact to be achieved the detail of the exact green metrics applied
are less important than their adoption by the broader chemical community.
Of growing importance is the replacement of fossil resources with renewable
alternatives to reduce greenhouse gas emission that is a significant driver
of climate change. The C factor is used to compare the carbon footprints of
different routes to a particular product.
4. select article Using polymeric hydroxypropyl methylcellulose as an
alternative to ‘micellar catalysis’ to enable chemical reactions in water
https://doi.org/10.1016/j.cogsc.2021.100571
Review articleAbstract only
USING POLYMERIC HYDROXYPROPYL METHYLCELLULOSE AS AN ALTERNATIVE TO
‘MICELLAR CATALYSIS’ TO ENABLE CHEMICAL REACTIONS IN WATER
Niginia Borlinghaus, Valentin Wittmann, Wilfried M. Braje
February 2022Article 100571Purchase PDF
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* Abstract
ABSTRACT
Synthetic chemistry relies heavily on organic solvents which are often
toxic and hazardous as well as expensive in purchase and disposal. The
application of water as an alternative reaction medium is not only
advantageous from an environmental and safety perspective but can also
offer improved selectivity and reaction rates. The exploration of this new,
sustainable approach comes along with an ever-growing spectrum of reaction
procedures. In this current opinion, we provide an overview of a new
methodology that uses a polymeric cellulose derivative, hydroxypropyl
methylcellulose, to enable chemical reactions in water.
5. select article Insights into EcoScent Compass™, a holistic tool to measure
a fragrance's sustainability footprint, based on its intrinsic green
properties and environmental impact
https://doi.org/10.1016/j.cogsc.2021.100583
Review articleAbstract only
INSIGHTS INTO ECOSCENT COMPASS™, A HOLISTIC TOOL TO MEASURE A FRAGRANCE'S
SUSTAINABILITY FOOTPRINT, BASED ON ITS INTRINSIC GREEN PROPERTIES AND
ENVIRONMENTAL IMPACT
Fabrice Robvieux, Jocelyn Roth, Christian Chapuis, Maud Reiter
February 2022Article 100583Purchase PDF
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* Abstract
In response to demands for more transparency on the impact of its fragrance
products on both people and the planet, Firmenich developed a new, holistic
digital assessment tool, EcoScent Compass™, to rank both perfumery
ingredients and perfumery formulations in terms of green chemistry as well
as environmental footprint criteria. Using knowledge gathered in the field
of green and sustainable chemistry over the past 20 years,
multi-indicator clusters have been deployed and combined into a single
index for green properties and environmental impact.
6. select article Defossilization of pharmaceutical manufacturing
https://doi.org/10.1016/j.cogsc.2021.100586
Review articleOpen access
DEFOSSILIZATION OF PHARMACEUTICAL MANUFACTURING
Lea Wollensack, Kristi Budzinski, Jan Backmann
February 2022Article 100586Download PDF
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* Abstract
As is true with most established industries, a significant portion of the
raw materials used in the pharmaceutical industry is of fossil origin, that
is, essentially can be traced back to crude oil. The present article
attempts to assess to which degree the modern manufacturing of
pharmaceuticals depends on raw materials of fossil carbon compounds and
which could be appropriate ways to increasingly switch to non-fossil
sourcing to eventually completely defossilize the raw-material base of the
sector.
7. select article Designing for sustainability with biocatalytic and
chemoenzymatic cascade processes
https://doi.org/10.1016/j.cogsc.2022.100591
Review articleAbstract only
DESIGNING FOR SUSTAINABILITY WITH BIOCATALYTIC AND CHEMOENZYMATIC CASCADE
PROCESSES
Chihui An, Kevin M. Maloney
April 2022Article 100591Purchase PDF
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* Abstract
ABSTRACT
Cascade reactions have been widely recognized to cut costs, decrease
solvent usage, and reduce cycle times in chemical processes. Recently,
biocatalytic cascades have altered how we design synthetic routes to
complex molecules to achieve sustainable commercial processes for
pharmaceutical, agricultural, and fine chemical industries. With
advancements in protein engineering and an increase in the number of enzyme
classes available to chemists, industrial and academic groups alike have
endeavored to expand the scope of biocatalysis from single reactions to
multi-enzyme cascades to rapidly build complex molecular structures. Recent
reports have drawn inspiration from biosynthetic pathways and have applied
engineered enzymes to in vitro enzymatic cascades. Furthermore, combining
transition-metal catalysis and enzymes in one-pot chemoenzymatic cascades
likewise serves to broaden the scope of biocatalysis, enabling traditional
chemical reactions to be performed under mild aqueous conditions. In this
article, we review recent biocatalytic and chemoenzymatic cascades from
2019 to 2021.
8. select article “The hidden power and competitive advantage of applying
green chemistry metrics”
https://doi.org/10.1016/j.cogsc.2022.100606
Review articleAbstract only
“THE HIDDEN POWER AND COMPETITIVE ADVANTAGE OF APPLYING GREEN CHEMISTRY
METRICS”
John L. Tucker
June 2022Article 100606Purchase PDF
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* Abstract
ABSTRACT
Green chemistry (GC) metrics provide insight into the relative waste, time
and cost implications of pharmaceutical chemical processes and serve to
guide scientists in the strategic application of resources to develop more
efficient and sustainable processes. Examples of the application of GC
metrics in evaluating pharmaceutical process efficiency and the subsequent
development toward improvement exist in abundance from journals such as
Organic Process Research and Development, Green Chemistry, or as
encompassed by the winning examples from the ACS GCI Pharmaceutical
Roundtable's [1] Peter J. Dunn award [2] or the US EPA's Green Chemistry
Challenge award [3]. By their nature, GC metrics are continuously evolving
but justify the necessary, unceasing investment in understanding and
application as they offer unique, opportunistic insight serving to guide
scientific resource deployment when developing greener pharmaceutical,
chemical processes.
9. select article Green metrics for biologics
https://doi.org/10.1016/j.cogsc.2022.100614
Review articleAbstract only
GREEN METRICS FOR BIOLOGICS
Sarah Argoud, Kristi Budzinski, Daniel D'Aquila, Sri R. Madabhushi, Phillip
Smith
June 2022Article 100614Purchase PDF
Article preview
* Abstract
ABSTRACT
Biologics are the fastest growing segment of the pharmaceutical market,
therefore, the environmental impact of manufacturing these drugs needs to
be fully characterized. For monoclonal antibodies, in particular, several
metrics have been identified as the manufacturing process is quite
standardized for batch processes. This paper will provide an overview of
carbon footprint analysis, process mass intensity (PMI), water related
impact of energy (WARIEN) and life cycle assessment (LCA) as they have been
applied to monoclonal antibody production. Further development and
standardization of these tools will allow the industry to identify and
implement new technologies that significantly lower the environmental
impact of not only monoclonal antibody production but other modalities as
well.
10. select article Trimming synthetic peptide and oligonucleotide waste-lines
https://doi.org/10.1016/j.cogsc.2022.100643
Review articleAbstract only
TRIMMING SYNTHETIC PEPTIDE AND OLIGONUCLEOTIDE WASTE-LINES
Michael E. Kopach, Benjamin I. Andrews
October 2022Article 100643Purchase PDF
Article preview
* Abstract
ABSTRACT
This review article highlights the need for the development of synthetic
peptide and oligonucleotide manufacturing processes with improved
sustainability credentials. These therapeutic classes are fast growing and
have the potential to deliver multiple high volume products over the next
decade. While there have been significant technical innovations in the past
few years there is limited evidence for adoption of these new technologies
in manufacturing, which still largely rely on traditional approaches that
generate large quantities of waste and use many chemicals of concern.
Examples of strategies that could improve the environmental footprint for
peptides include Tag-Assisted Liquid-Phase Peptide Synthesis, Hybrid
Solid/Liquid Phase Peptide Synthesis and the implementation of continuous
processes. For oligonucleotides, convergent liquid-phase synthesis and
enzyme-catalyzed synthesis strategies are highlighted which have potential
for significant positive environmental improvement if incorporated into the
development lifecycle. To guide development, the collection of baseline
sustainability metrics such as Process Mass Intensity is recommended.
11. select article Assessment of analytical testing: The impact of metrics for
the sustainable measurement of pharmaceuticals
https://doi.org/10.1016/j.cogsc.2022.100689
Review articleAbstract only
ASSESSMENT OF ANALYTICAL TESTING: THE IMPACT OF METRICS FOR THE SUSTAINABLE
MEASUREMENT OF PHARMACEUTICALS
Michael B. Hicks, Sean Oriana, Yong Liu
December 2022Article 100689Purchase PDF
Article preview
* Abstract
ABSTRACT
Analytical metrics allow a periodic, healthy examination of methods and how
they impact the environment, while ensuring that procedures are
reproducible, reliable, repeatable, transferable, and of high quality. This
article provides a review of current trends with analytical metrics, such
as the analytical method green score (AMGS). More importantly, the AMGS
impact on sample preparation, development strategy, and energy consumption
considerations are provided. Finally, recent uses of metrics with specific
relevance to the pharmaceutical research and development area through
method transfer are covered.
12. select article National leadership and cross-sector collaboration could
help overcome differences in stakeholder definitions of sustainable
chemistry
https://doi.org/10.1016/j.crgsc.2021.100222
Research articleOpen access
NATIONAL LEADERSHIP AND CROSS-SECTOR COLLABORATION COULD HELP OVERCOME
DIFFERENCES IN STAKEHOLDER DEFINITIONS OF SUSTAINABLE CHEMISTRY
Summer Lingard Smith, Diane B. Raynes, Karen L. Howard
2022Article 100222Download PDF
Article preview
* Abstract
ABSTRACT
GAO conducted a technology assessment to explore among other things, the
opportunities, challenges, and stakeholder roles in sustainable chemistry.
We found that stakeholders across industry, government, and academia lack
agreement on how to define sustainable chemistry and how to measure or
assess the sustainability of chemical processes and products. These
differences hinder the development and adoption of more sustainable
chemistry technologies. However, based on a review of the literature and
stakeholder interviews, GAO identified several common themes underlying
what sustainable chemistry strives to achieve – including that standard
definitions and metrics for sustainability are important for stakeholders.
In addition, we note that national leadership and collaboration across many
sectors could enhance sustainable chemistry progress. This includes the
potential for sustainable chemistry to inspire new products and processes,
create jobs, and enhance benefits to human health and the environment.
However, we found that technological and business challenges interfere with
efforts to implement some of these sustainable chemistry technologies, and
that the diverse set of stakeholders can lead to coordination challenges.
We offer strategic approaches that may help overcome these challenges.
13. select article Manufacturing mass intensity: 15 Years of Process Mass
Intensity and development of the metric into plant cleaning and beyond
https://doi.org/10.1016/j.crgsc.2021.100229
Research articleOpen access
MANUFACTURING MASS INTENSITY: 15 YEARS OF PROCESS MASS INTENSITY AND
DEVELOPMENT OF THE METRIC INTO PLANT CLEANING AND BEYOND
Colin H. Benison, Philippa R. Payne
2022Article 100229Download PDF
Article preview
* Abstract
ABSTRACT
The American Chemical Society Green Chemistry Institute (ACS GCI)
Pharmaceutical Roundtable is committed to continue to expand and identify
elements of small-molecule active pharmaceutical ingredient (API)
manufacturing that should be quantified to drive towards more sustainable
practices. Process mass intensity (PMI) has been used for over 15 years to
evaluate and benchmark progress towards more sustainable manufacturing and
quantifies process input mass (e.g. solvent, water, reagents) per mass of
output produced. This manuscript introduces Manufacturing Mass Intensity
(MMI), a metric that builds upon and expands the scope to account for other
raw materials required for API manufacturing. Examples are included to
illustrate how quantification of these additional resource requirements
will drive more sustainable practices.
14. select article Grassroots and blue skies lead to greener landscapes
https://doi.org/10.1016/j.crgsc.2021.100242
Research articleOpen access
GRASSROOTS AND BLUE SKIES LEAD TO GREENER LANDSCAPES
Kristi Budzinski, Stefan G. Koenig
2022Article 100242Download PDF
Article preview
* Abstract
* Graphical abstract
GRAPHICAL ABSTRACT
15. select article Engaging scientists in a sustainability culture
https://doi.org/10.1016/j.crgsc.2021.100247
Research articleOpen access
ENGAGING SCIENTISTS IN A SUSTAINABILITY CULTURE
Louis J. Diorazio, Alex Mullen
2022Article 100247Download PDF
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* Abstract
* Graphical abstract
GRAPHICAL ABSTRACT
16. select article Sustainability case studies on the use of continuous
manufacturing in pharmaceutical production
https://doi.org/10.1016/j.crgsc.2022.100279
Research articleOpen access
SUSTAINABILITY CASE STUDIES ON THE USE OF CONTINUOUS MANUFACTURING IN
PHARMACEUTICAL PRODUCTION
Mark S. Kerr, Kevin P. Cole
2022Article 100279Download PDF
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* Abstract
ABSTRACT
Continuous processing is now commonly used in the manufacturing of fine
chemicals including agrochemicals and pharmaceuticals. Datasets are now
available, including some on environmental sustainability aspects, that
enable more direct comparison between related batch and flow processes.
This article examines six continuous processes where an environmental
sustainability concept or metric (e.g. process mass intensity) can be
compared to that from a closely-related batch process in order to assess
the impact that continuous manufacturing has on that theme. Some current
case studies where additional Green Chemistry concepts are exemplified are
shared along with how continuous processing impacts the manufacture. We
illustrate situations where continuous processing can reasonably be
expected to show sustainability advantages over batch, as well as a
scenario where increased solvent usage in flow mode worsened the
environmental profile. While we believe that continuous processing can
provide sustainability benefits, there are cases where its application can
have a negative effect on environmental metrics. Our hope is to provide
impartial guidance for development and manufacturing scientists so they may
best utilize continuous technologies in an environmentally responsible way.
17. select article Roche's approach to green metrics in drug development
https://doi.org/10.1016/j.crgsc.2022.100293
Research articleOpen access
ROCHE'S APPROACH TO GREEN METRICS IN DRUG DEVELOPMENT
Georg Wuitschik, Martin Olbrich, Stefan Hildbrand
2022Article 100293Download PDF
Article preview
* Abstract
ABSTRACT
This article describes standard, often used metrics and more recent
developments. Efforts and possibilities on how to apply them in drug
development are shown on the example of Roche.
18. select article Green and sustainable metrics: Charting the course for
green-by-design small molecule API synthesis
https://doi.org/10.1016/j.crgsc.2022.100324
Research articleOpen access
GREEN AND SUSTAINABLE METRICS: CHARTING THE COURSE FOR GREEN-BY-DESIGN
SMALL MOLECULE API SYNTHESIS
Harrison B. Rose, Birgit Kosjek, Brittany M. Armstrong, Sandra A. Robaire
2022Article 100324Download PDF
Article preview
* Abstract
ABSTRACT
Sustainable small molecule Active Pharmaceutical Ingredient (API)
manufacturing starts at the onset of route development by employing a
Green-by-Design strategy. Reliable metrics are imperative for setting
targets and measuring process improvements throughout the development
cycle. This article reviews some of the many tools and methods established
to analyze and assess the greenness and sustainability of a process, each
of which highlights different aspects of process efficiency, waste
formation or overall environmental impact reduction. Most calculations,
such as process mass intensity (PMI), are mass-based and do not consider
the types of raw materials used. In contrast, a full life cycle assessment
(LCA) offers detailed information about the “cradle to grave” environmental
impact of a manufacturing route and its specific resources, but the high
data requirements and long timelines are not conducive for multiple
processes or repeated assessments during process optimization. To address
these challenges, we introduce a Streamlined PMI-LCA Tool, developed in
collaboration with the ACS Green Chemistry Institute Pharmaceutical
Roundtable (ACS GCIPR), that combines PMI with a “cradle to gate” approach
to include the environmental footprint of the synthesis’ raw materials. The
frequent re-evaluation of a process continuously highlights areas for
improvement and guides the prioritization of process development activities
to effectively and rapidly achieve a Green-by-Design commercial synthetic
route. The utility of this approach to Green-by-Design is demonstrated with
the reduction of PMI for MK-7264 from 366 to 88 over the course of process
development.
ISSN: 2452-2236
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