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Vol. 31, n. 2, 2013
LINKED SUPPLEMENTS
  CONTENTS
FROM THE SCIENTIFIC ADVISORY BOARD
COVER STORY
GREEN CHEMISTRY/SUSTAINABILITY
PROCESS INTENSIFICATION
BIOSIMILARS
BIOTECHNOLOGY
NEWS
Some applications of Murphy’s Law in process chemistry
Authors: IAN GRAYSON (Member of Chimica Oggi)
Murphy’s law is usually expressed as “if anything can go wrong, it will” (1). As a process chemist, I have found that a more accurate expression of Murphy’s law is “no matter how many scenarios you test in the laboratory, something will happen on the plant which you did not envisage”. In this respect, Murphy’s is the opposite of serendipity, which is defi ned as fi nding something useful while not looking for it (2). Unfortunately, serendipitous results occur far less frequently in the life of a process chemist.
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Sabinsa 1988-2013: 25 years of success
Authors: Fezzardini G. (Teknoscienze, Milano, Italy)
April 2003. I was in Paris, Port Versailles, attending the In-Cosmetics fair with a project in mind: the presentation of a new publication of Te knoscienze, Household and Personal Care today. On that occasion, I recall meeting a person in particular, a meeting that would have yielded much more in the future. As we all know, though we live in a time of advanced technology governing all aspects of our everyday life, what really triggers a process is the “human touch” in the end.
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Cluster thinking as part of sustainable chemical plants
Authors: GENSERIK L. (University of Antwerp, Antwerp, Belgium) RENIERS L. (Centre for Economics and Corporate Sustainability, Brussels, Belgium)
ABSTRACT: ‘Cluster thinking’ is coined in this article as a mindset and as an approach to tackle sustainability on an industrial park level. At present, single chemical plants are still focusing too much on individual technological advancements for becoming more sustainable, while, if situated in a cluster, chemical plants require foremost a holistic collaborative approach and the optimal use of existing technology on a cluster level, to become sustainable and to maintain being sustainable. Single plants working together to implement joint solutions, technological as well as non-technological, truly leads to a sustainable chemical industry.
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Alicyclic ammonium ionic liquids as lithium battery electrolytes A review
Authors: PUGA A.V. (Instituto de Tecnología Química, Valencia, Spain)
ABSTRACT: Ionic liquids are reasonable alternatives to electrolytes used in energy storage devices, such as lithium batteries, both lithium-ion and lithium-metal, given the safety advantages they provide. This is due to the favourable properties they often possess, mainly non- fl ammability and non- volatility. Candidates with alicyclic ammonium cations exhibit high electrochemical stabilities, especially towards lithium, a unique feature which enables the fabrication of reversible lithium- metal batteries. Recent advances in this fi eld are reviewed herein, with emphasis on two new families of ionic liquids, based on either azepanium or 3 -methylpiperidinium cations, and having potential windows around or above 6 V.
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LCA based evaluation of site remediation Opportunities and limitations
Authors: CAPPUYNS V. (Hogeschool-Universiteit Brussel, Brussels, Belgium)
ABSTRACT: During the last 10 years, several instances have emerged in which a life cycle approach has been applied to the remediation of contaminated sites. A life cycle management (LCM) approach structuring environmental activities and life cycle assessment (LCA) for a quantitative examination, can be helpful for the selection of site remediation options with a lower impact on the ecosystem and human health. Besides addressing the environmental impacts of the remediation activities for a specifi c site, attention should also be paid to the engagement of different stakeholders and socio-economical consequences of reintroducing a remediated site into the economy.
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Biobased Products in the Fracking Age Green Demand without the Price Premium
Authors: BOGDAN COMANITA (MarketChemica, Ottawa, ON K1H 5A4, Canada)
ABSTRACT: The latest Infocast Annual Meeting on Next Generation Biobased Chemicals confi rms previous concerns regarding the impact of the fracking industry in US on the continued growth of the sector. The brand owners, NGOs and service providers repeatedly reinforced the idea that green demand remains real on the consumer side however the biobased chemicals manufacturers’ sentiment was that a green price premium is increasingly unacceptable in the present economic climate. Besides the profi tability cap, the biobased industry might see lower growth rates due to waning governmental subsidies in 2013 and beyond. This will likely impact the fi nancing and investment in the biobased industry, one of the very few brighter spots in the manufacturing sectors. Under these circumstances, companies promoting biobased products need to see supply risk, product performance and price as mere business qualifi ers while counting on the green value proposition as differentiator for select markets only. With steel going in the ground for numerous demonstration and commercialization plants in 2013 the speakers highlighted that gas supply from fracking will pose challenges for some while providing new opportunities for others.
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Intensifi ed azeotropic distillation A novel, industrially viable approach to direct amidation
Authors: GROSJEAN C., PARKER J.,WRIGHT A. R. (School of Chemical Engineering and Advanced Materials, Newcastle-upon-Tyne, NE1 7RU, United Kingdom ) CARL THIRSK (LyraChem Ltd. St Thomas Street Stables, Newcastle-upon-Tyne, NE1 4LE, United Kingdom)
ABSTRACT: Intensifying the boil up rate of azeotropic reactive distillation offers a novel and industrially viable means of increasing the rate of condensation reactions. The strategy can be as effective as using a catalyst and may lend itself to continuous operation. When applied to the condensation of carboxylic acids and amines such intensifi cation provides an environmentally-benign route to a variety of amides. The impact of intensifi ed azeotropic distillation on direct amidation using both a production scale batch reactor and a cascade of CSTRs is discussed and compared.
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Applying Quality by Design to spray drying - The role of empirical and mechanistic modeling
Authors: JOÃO V., JOÃO P., MENEZES J., GASPAR F.
ABSTRACT: The purpose of this work was to build different models to predict the particle size of spray dried powders and assess their usefulness in the design space establishment. Powders were obtained by spray drying solutions of a known pharmaceutical excipient (hypromellose phthalate). The powders were characterized by image analysis (for particle size and circularity), loss on drying (for residual solvent content) and helium pycnometry (for particles density). A full factorial experimental design was performed and PLS regression was used to establish a statistical model. In addition, mechanistic modeling of droplet formation based on hydrodynamic instabilities was also used to estimate the size of particles. Spherical particles, with average particle size between 3 and 9 mm, were obtained by spray drying solutions in a lab scale unit. Particle density and residual solvent content did not vary signifi cantly between experiments. Statistical and mechanistic approaches were compared. Both statistical and mechanistic models were able to describe the results observed, although the mechanistic model was the most accurate. The mechanistic description of droplet formation was of great assistance to understand and describe the spray drying process.
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The global biosimilars market: a look forward
Authors: SPAR E.N. (Sunstein Kann Murphy & Timbers LLP, Boston, MA 02110-1618, USA), WINTNER T. (Edwards Wildman Palmer LLP, Boston, MA 02199, USA)
ABSTRACT: Producers of biosimilars must prepare a global strategy for development of a biosimilar product to ensure maximum benefi t from their investment. This article discusses numerous factors that will affect cost and time associated with biosimilar development.
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Biosimilar development: step by step
Authors: FIONA M. GREER (SGS M-Scan, Berkshire, United Kingdom)
ABSTRACT: Many countries have now established legal and regulatory pathways which allow manufacture of “copies” of a patent–expired biotherapeutic product. Companies developing these “copies” must demonstrate that they are similar by performing a side-by-side comparison with a reference sample of the originator molecule. There are many challenges - legal, regulatory, non-clinical and clinical - which manufacturers must rise above to develop biosimilar products for global markets. One of the fi rst hurdles to be negotiated prior to biological and clinical testing is demonstrating physicochemical similarity to the originator. This task requires a thorough understanding of glycoprotein structure and appropriate and sensitive analytical techniques to probe it.
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Requirements for comparability of biosimilars
Authors: CALVO B., GÓMEZ P. (University of the Basque Country, Vitoria-Gasteiz, Spain)
ABSTRACT: Since 2005, the European Medicines Agency (EMA) has published several guidelines laying down the regulatory framework for biosimilars approval. Based on the experience gained over these years, some initial guidelines are being revised to adapt them to the production of more complex biosimilar medicinal products. Nowadays, the adoption by the Committee for Human Medicinal Products (CHMP) of two concept papers on the revisions of the fi rst biosimilar guideline and the guideline relating to non-clinical and clinical issues of biosimilar is pending. Likewise, the fi rst revision of biosimilars guideline on quality issues has been drafted. Nevertheless, while new guidelines do not come into effect, applicants should follow the guidelines in force. This article reviews the studies needed for the development comparability exercise for biosimilars at quality, non-clinical and clinical levels according to the EMA regulatory guidance.
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Cellulolytic Bacillus strains from natural habitats - A review
Authors: AMORE A., PEPE O., VENTORINO V., ALIBERTI A., FARACO V.
ABSTRACT: Fossil fuel reserves depletion, global warming, costly and problematic waste recycling and population growth greatly induce to fi nd renewable energy sources. Second generation bioethanol produced from lignocellulosic materials exhibits great potential as liquid biofuel to substitute gasoline. Production costs of enzymes involved in cellulose hydrolysis into fermentable sugars represent the main obstacle to achieve competitive production of cellulosic ethanol. Cheaper and more effi cient biocatalysts for the saccharifi cation step are, therefore, required for making the whole process more competitive. The biodiversity of natural niches has been so far exploited for the isolation of new cellulolytic microorganisms whose enzymes are naturally evolved for an effi cient conversion of cellulose into fermentable sugars. This review discusses advances in isolation of bacteria, namely Bacillus spp., from several natural habitats and their ability to produce cellulase activity.
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NEWS
Authors:
Researchers from North Carolina State University have developed a new technique to identify the proteins secreted by a cell. The new approach should help researchers collect precise data on cell biology, which is critical in fi elds ranging from zoology to cancer research. The work is important because cells communicate by secreting proteins. Some of the proteins act on the cell itself, telling it to grow or multiply, for example. But the proteins can also interact with other cells, infl uencing them to perform any biological function. Traditionally, scientists who wanted to identify these proteins cultured cells and then used mass spectrometry to determine which proteins appeared in the medium the cell was grown on. This has drawbacks, because the proteins of interest are fairly rare compared to the proteins that are already in the medium -- which are used to grow and support the cells in the fi rst place. Further, any attempts to culture the cells without these background, supporting proteins affects cell behavior -- skewing the sample. The new approach takes advantage of the fact that each cell "packages" its proteins in its "secretory pathway." Each cell synthesizes the protein and passes it through this pathway, essentially placing it in a bag-like membrane before it is passed out of the cell.
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