Pharmaceutical industry, biocatalytic

Altus has developed proprietary technology platform, known as Crystalomics , to enable the rapid commercialization of high-value protein-based products. The primary focus is on the 300 billion pharmaceutical industry, where the technology is designed to significantly accelerate the development of both large and small molecule pharmaceuticals. The Crystalomics platform addresses the major limitations in protein-based developments by enabling protein candidates transformation into their crystalline state. The application of the Crystalomics platform is in the development of protein-based biocatalytic products and processes, for use in the production of small molecule pharmaceuticals, for therapeutical purposes. 

Table 1.3 List of key areas of green chemistry of importance to the pharmaceutical industry (in ascending order) areas where biocatalytic precedent exists are given in bold.

Biocatalytic processes increasingly penetrate the chemical industry. In a recent study, 134 industrial-scale biotransformations, on a scale of > 100 kg with whole cells or enzymes starting from a precursor other than a C-source, were analyzed. Hydrolases (44%), followed by oxido-reductases (30%), dominate industrial biocatalytic applications. Average performance data for fine chemicals (not pharmaceuticals) applications are 78% yield, a final product concentration of 108 g I.1, and a volumetric productivity of 372 g (L d) 1. 

Drioli, E. and Giorno, L. (1999) Biocatalytic Membrane Reactors Application in Biotechnology and the Pharmaceutical Industry, Taylor Francis Publisher, Padstow, UK. 

Since the mid-1970s biotransformations have become a very well-established tool in the fine chemicals industry. Biocatalytic systems, including crude and purified enzymes as well as whole-cell systems performing highly selective reactions under mild conditions, are widely used, especially in synthesis and production of biologically active compounds in the agrochemical and pharmaceutical sectors. 

The examples given in Section 4.2 demonstrate that state-of-the-art biocatalytic transformations have reached an extraordinary level making them valuable and competitive methods for use in the pharmaceutical industry. Progress made in the fields of chemoenzymatic synthesis, molecular biology and reaction engineering will improve and enlarge the possible apphcations of biocataiysts even further. 

A general review of continuous processing/process intensification in the pharmaceutical industry has been made by Rubin ef a. [22], while the use of PI novel technologies to reshape the petrochemical and biotechnology industries has been analyzed by Hahn [23] and Akay [24], respectively. Recent advances in biotechnology process intensification have also been reviewed by Choe ef al. [25] and Akay et al. [26]. The use of monoliths as biocatalytic reactors to achieve PI by smart gas-liquid contact has been reviewed by Kreutzer ef al. [27]. 

Amano Amano Pharmaceutical Co., Ltd. 2-7,1-chome, Nishiki Naka-ku, Nagoya, 460-8630 Japan Tel +81 (52) 211-3032 Fax +81 (52) 211-3054 http //www.amano-enzyme.co.jp Specialty enzyme producer for industrial, biocatalytical, diagnostic, and medicinal applications. 

With the access to diverse and stable biocatalysts, more and more conventional chemical processes (first generation) in pharmaceutical manufacturing have been replaced by second-generation biocatalysis processes with substantial impact on the pharmaceutical industry. In this chapter, some commonly used biocatalytic reactions for chiral preparation, including hydrolytic reactions, acyl and glycosyl transfer reactions, asymmetric reduction/ oxidation reactions, and asymmetric formation of C-C bonds, are introduced and exemplified by the research achievements developed by the authors laboratory as well as other research groups. Some of the bioprocesses described herein have been successfully applied on pilot or even industrial scale. ... 

Economic Perspectives of Biocatalytic Conversion of Aromatics to Optical Pure Synthons for the Pharmaceutical Industry... 

Antibody catalysts, role in environmentally benign synthesis of chemicals, 125-126 Aqueous-supercritical carbon dioxide medium, phase-transfer catalytic oxidation, 144-145 Arene cw-dihydrodiols, biocatalytic conversion of aromatics to optically pure synthons for pharmaceutical industry, 180-195... 

With two chiral centers, both of which can be installed by stereoselective ketone reduction, atorvastatin is ideally suited to the application of CREDs for its synthesis, a fact not lost on the pharmaceutical industry. Seven different biocatalytic processes have been developed by various groups to produce key intermediates for this large volume drug [9]. 

Biocatalysis has been established as an enviroiunentally friendly and sustainable alternative to conventional chemical processes in the pharmaceutical industry in the recent decade. Advances in recombinant DNA and genomics technologies, protein and metabolic engineering, as well as bioinformatics are critical in the discovery and development of biocatalysts for industrial processes. Significant progress has also been made in our ability to design biocatalytic cascades and to combine them with traditional chemocatalytic routes. The opportunities and combinations are endless. 

Biocatalytic Deracemization Dynamic Resolution, Stereoinversion, Enantioconvergent Processes and Cyclic Deracemization, in Biocatalysts in the Pharmaceutical and Biotechnology industries, (ed. R.N. Patel), CRC Press, Boca Raton, pp. 27-51. 

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