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Continuous processing is gaining interest in biopharmaceutical industry due to traditional justifications (such as higher productivity and lower costs) as well as its ability to address biopharmaceutical specificities. Continuous chromatography has been in use since the 1960s and has progressed across industries by capitalising on its previous applications, leading each time to major innovations. The successful implementation of continuous chromatography in the pharmaceutical industry in the 90s for the purification of small molecule APIs demonstrated the importance of technological expertise and mastery of regulatory aspects. As a result, several commercial processes have been approved and the technology remains an industrial standard. Biopharmaceutical industry is about to experience the same evolution. To succeed, proven understanding and experience in implementing continuous chromatography at an industrial scale will be key factors.
Chemicals for the manufacture of electronic devices are currently in the spotlight and the way from bench to industrial production is paved with challenges. Electronic chemicals are often produced from highly energetic intermediates, raising a number of safety concerns. In addition, these compounds are required in very high and specific purity grades. A combination of safe and proven manufacturing practices and suitable purification processes is needed to provide the high quality chemicals needed in this high-tech market.
Bio-based chemicals are gaining interest as alternatives or additional sources of chemicals. Among them,organic acids are promising as building blocks and chemical platforms. To integrate the chemical industry supply chain, bio-based products must become commodity products and meet current specifications applied to petro-based chemicals in terms of quality and purity. This article will illustrate several purification challenges that manufacturers encounter by describing an industrial manufacturing process for citric acid production from fermentation to purification.
Each step will be reviewed and explained with special emphasis on the continuous chromatography step based on acid retardation since it is the core operation unit of the described purification process.
Molecules reaching the market in the recent years present an ever-growing complexity. In the meantime, purity criteria are more important than ever to ensure patients safety. The combination of these two facts represents a big challenge for the manufacturing industry where the right combination of state-of-the-art synthesis and advanced purification is necessary to meet the demand in a cost-effective and time-efficient manner. This paper presents membrane filtration and chromatography as efficient technologies to reach the required purity level. The use of these technologies at industrial scale is illustrated through a case study including a complex biocatalysis reaction and the complete downstream processing yielding the final, pure product. The scale-up from gram to hundred kilogram scale, process efficiency and timelines are also considered.
Carbon monoxide can be used to transform a wide range of substrates. In the process, the carbon chain is extended and an attractive functionality, a carbonyl group, is added. In many cases, instead of a multi-step synthesis, the targeted product can be obtained in a single selective catalytic step, resulting in a substantially higher overall yield.This is particularly important for long synthesis sequences.
Downstream processing is a sequence of unit process operations that purify biopharmaceuticals and prepare them primarily for bulk formulation. Typically, a large volume is delivered from an upstream fermentation or cell culture process.
Armodafinil, the (R)-enantiomer of modafinil, is a medication used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. We report here the chemical development of armodafinil and the investigations that led to a commercial route to prepare this pure enantiomer. Three synthetic approaches were used to provide the chiral sulfoxide.
Une méthode est élaborée pour déterminer la solubilité des substances organiques dans une large gamme de solvant. La méthode et l'appareillage sont d'abord testés pour déterminer la solubilité de la DL-sérine, qui représente un cas où les données de solubilité sont connues avec précision. Un excellent accord est obtenu entre les valeurs de solubilité obtenues par notre méthode et les valeurs fournies par la littérature ; l'erreur maximale ne dépasse pas 0,9%. La méthode ainsi validée, est utilisée dans un cas concret pour construire le diagramme de solubilité du mélange des énantiomères d'ibuprofène dans l'hexane. Cette étude a montré que la méthode proposée est fiable, peu coûteuse et facile à mettre en oeuvre pour tous les produits organiques solubles dans pratiquement n'importe quel type de solvant.