Biotechnologies process development

The scale-up of biotechnological processes developed in the laboratory often presents problems that owing to the complexity of multiple parameters do not permit a generalized solution. This section focuses on the empirical approach to scale-up and highlights the difficulties in maintaining kinematic similarity at different scales. In addition, it highlights the need to account for the biological... 

Calam C.T. (1987) Process Development in Antibiotic Fermentations, Cambridge Studies in Biotechnology, 4 (eds Sir James Baddiley, N.H. Carey, J.F. Davidson, I.J. Higgins W.G. Potter). Cambridge Cambridge University Press. 

Avecia is a biotechnology company directed to the development and manufacturing of biotechnology based medicines. It is structurally organized in two business units, namely Biologies and DNA Medicines. Its capabilities comprise process development, scale-up, and manufacture of microbial-derived biopharmaceuticals and oligonucleotides. 

BPD is a contract research facility, which started operations in 1996. From the storage of frozen materials, the customized laboratory services to the consulting in process development and scaling up, BPD has been accumulating useful experiences in the biotechnological scenario. Very flexible set of fermenters are used to satisfy customer needs, through very small and fast adaptation and modifications. Bioreactors productivity varies from 100 mg to 1000 mg scale. 

Goodwin Biotechnology, Inc. (GBI) is a fully integrated GMP contract manufacturer of mammalian cell products providing process development (upstream and downstream) and cell banking through production, purification, and sterile fill. The downstream... 

Although, MediChem is a biosecurity products manufacturer, its biotechnology-based R D capabilities are worth mentioning here. The attended markets include Medical, Laboratory, Veterinary, and Environmental sectors. Medicinal chemistry services and drug discovery form the basis of the company, though their capabilities might be applied in a broader range of sectors. These capabilities comprise the areas of Proteomics, Combinatorial and Computational Chemistry, Medicinal Chemistry, Enzymes, Process Development, Analytical and Separations Chemistry, Chemical Synthesis and Scale Up. 

Horseradish peroxidase (HRP) is an extracellular plant enzyme that acts in regulation of cell growth and differentiation, polymerization of cell wall components, and the oxidation of secondary metabolites essential for important pathogenic defense reactions. Because of these essential functions, and also because of its stability and ready availability, HRP has attracted considerable attention.13 It has been involved in a number of applications, such as diagnostic assays,14 biosensors,15 bioremediation,16 polymer synthesis,17 and other biotechnological processes.18 More applications in which HRP catalysis is translated into an electrochemical signal are likely to be developed in the near future. 

The expected contribution of catalysis in this area will derive both from the availability, at low processing costs, of new monomers obtained from biomasses and from the development of an optimized combination of biotechnology processes with classical and new biocatalytic processes. Research priorities for catalysis in the area of polymers from renewable materials for packaging, furniture, domestic water purification and recycling include the need to develop novel catalysts, e.g., for functionalization of polymeric and dendrimeric materials, with side-chain photoactive molecular switches (to be used as smart materials), or the development of multifunctional materials, combining, for example, nanofiltration with catalytic reactivity. 

Any medicinal product developed by means of one of the following biotechnological processes ... 

Medicinal products developed by other biotechnological processes which, in the opinion of the EMEA, constitute a significant innovation... 

A stereospecific synthesis for cw-3-hexen-l-ol starts with the ethylation of sodium acetylide to 1 -butyne, which is reacted with ethylene oxide to give 3-hexyn-l-ol. Selective hydrogenation of the triple bond in the presence of palladium catalysts yields cw-3-hexen-l-ol. Biotechnological processes have been developed for its synthesis as a natural flavor compound, e.g., [12]. 

CH3(CH2)4CH = CHCH = CHC00CH2CH3, C12H20O2, Mr 196.29, bp6i> 70-72 °C, has been identified in pears and has the typical aroma of Williams pears. Synthesis of ethyl 2-trans-4-cw-decadienoate starts from cis-l-heptenyl bromide, which is converted into a 1-heptenyllithium cuprate complex with lithium and copper iodide. Reaction with ethyl propiolate yields a mixture of 95% ethyl 2-trans-A-cis- and 5% ethyl 2-tranx-4-tranx-decadienoate. Pure ethyl 2-trans-A-cis-decadienoate is obtained by fractional distillation [25]. A biotechnological process for its preparation has been developed [26]. 

To cater for the large demand for vanillin, besides different synthetic methods also biotechnological processes have been developed. Synthetic vanillin has a major drawback that products containing this compound cannot be labelled as containing a natural flavour. On the other hand, biotechnological products can be labelled as natural. 

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