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This statement is confirmed by evaluating factor VIII and the biopharmaceutical somatropin because these two biological products have a low unit value and are brought to market by at least four world producers. The biopharmaceutical betainterferon is shown in Tables 3 and 4 in two forms, 1a and 1b, and this term depends on the expression system used in its production. The difference in the molecular weight of the forms of the biopharmaceutical obtained at the end of the process may be approximately 22, Daltons or 18, Daltons, for betainterferon 1a and betainterferon 1b, respectively.

This difference in the structure of the molecule is very important for defining the biopharmaceutical purification process. Table 4: Identifying the technological interest in selected biopharmaceuticals. This technique decreases the interval of drug dosing for the patient, requiring only a daily injection of a 6 mg under the skin after about 24 hours of the cycle of chemotherapy, which allows the drug to be released slowly in the body. Biological products can be produced after the first patent expires, so the expected number of biosimilars is expected to increase after the release period of the first generation of biologically sourced drugs, which started in the mids, expires.

Figure 2 shows a graph with the temporal end of the patent. With these data, it is possible to imagine that many biosimilars will enter the market soon to compete with these products of high added value. Figure 2:The timeline for the expiration of patents for the commercial products of interest. However, a biosimilar product is faced with not only the problem of obtaining a protein that replicates the structure and conformation of the original product but also the difficulty in achieving the recording the product not innovative.

Long, costly clinical studies should be performed to compare the original and the biopharmaceutical biosimilar, which makes the process of biosimilars very difficult from a practical point of view. A major challenge in obtaining the approval of regulatory agencies worldwide is the analytical characterization of the translational modifications that occur in proteins, particularly the processes of glycosylation addition of carbohydrate molecules and phosphorylation phosphate esterification reactions.

However, these hindrances do not prevent the production of biosimilar products; otherwise, there would not be as many different commercial products for somatropin and factor VIII produced from different expression systems Table 4.

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Nevertheless, a biosimilar may not always be much less costly than the original biopharmaceutical, as occurred with the introduction of generic medicines in the Brazilian market. However, biosimilars are not the only means of addressing the demands of the population in need of expensive biological products. A viral contamination of the equipment used to produce the medicinal plant in Allston in the United States was identified, and the U. Alternatively, because of the possible contamination of expression systems traditionally used by the pharmaceutical industry, such as mammalian CHO cells, some research centers are exploring the use of plants or plant cells to produce pharmaceuticals.

The enzyme glucocerebrosidase is being produced by an Israeli company Protalix Biotherapeutics from carrot cells, which is in a phase III clinical trial phase Kaiser, Additionally, plant cells offer several advantages in producing a vaccine, such as a low production cost, fast scheduling, and the absence of pathogens, making them capable of producing complex proteins safely because they retain the initial stages of post-translational modification N-glycosylation.

However, its modification of the oligosaccharide and the further processing of glycans in the Golgi apparatus differ from those in mammalian cells Butler, To complement the INPI patents with priority in Brazil showed that inventors observe the country as a future owner of technology and potential consumer market. However, the Instituto Nacional de Propriedade Intelectual does not have a database that represents the full technological deposits, as can be seen in the number of patents filed during the period since Table 5.

To understand how the production is linked to global technology, this study focused on patents in the USPTO, looking at not only granted patents but also patent applications that may contribute to future trends in producing biopharmaceuticals. The database Derwent Innovations Index was used to achieve integration and program support for the Vantage Point text mining because of the large amount of data available for this study. The USPTO database is used to provide a larger degree of technological foresight to study each of the six selected biological products and thus to trace the technological trajectory that was used after diagnosing a concrete platform technology for the production these drugs.

A more detailed study is presented in Figure 3 , showing the network between patents granted and applied for on glucocerebrosidase. We note that some patents have no connection with others, meaning that the state of the art of these patents was probably not important for generating knowledge at that time. However, the cluster that owns the patent-pending US , in Figure 3 B , demonstrates that the information contained in other documents that formed this network is relevant and that it may bring a new product to market.

The patents should be assessed on not only the formation of the network but also the strength of its connection, i. This graphical evaluation depicts connections and indicates a stronger connection by the presence of a line. Table 6 shows the relevant information about the selected documents and their importance. Therefore, the primary cluster shown in Figure 3 represents the trend of technological development in the formulation of drugs. This trend is also related to the organic products selected in this article, not only to glucocerebrosidase, because patents are not made exclusively to apply to a single biopharmaceutical.

Table 6:The relevant information about the selected documents and their importance. The graphical information should be evaluated by reading the patent and only those associated patents that had a role in the text mining. Table 6 provides some of the relevant information about the available patents cited in Figure 3.

Patent US 6,, shows the importance of pulmonary administration as an alternative route, which may offer several advantages over subcutaneous administration. These advantages include the convenience of patient self-administration, the reduction of potential side effects, the ease of administration by inhalation, the disposal of needles and so forth.

Patent US 6,, created an implant system as a carrier for medicines. The composition of these implants is based on an aqueous solution containing a biodegradable polymer that is easily synthesized and handled and that acts as a promising carrier to promote cell proliferation and biosyn- thesis, supporting physiological loads.

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The in situ gelling is based on injection systems and eliminates the need for surgical procedures, offering advantages and the ability to form any required implant patent. US , requested in , was granted a patent US 6,, in ; therefore, the connection between these two documents is quite strong Figure 3A. The pharmaceutical composition has a high dispersion and upper inhalable aerosols and is therefore preferred for administration to the lungs.

The dry powder contains an active agent and a dior tripeptide containing at least two leucyl residues. The composition is physically and chemically stable for storage. The prospects and trends of producing biopharmaceuticals in Brazil are of great interest to the country to establish a competitive industry and reduce the vulnerability of the National Health System. The importance of obtaining these drugs domestically at lower cost could provide an important foundation for achieving economic and social benefits, such as an increased market share in industrial biotechnology, which expands the range of drug treatment and the specialization of human resources in this technology area.


But, despite the complexity of the subject matter, producing biological products has become a widely debated topic in both academic and industrial contexts. The challenges involved in producing biological products drive research to answer the questions that arise throughout this work. The Industrial Health Complex for Brazil needs to strengthen its technology base to succeed in generating competitive pharmaceutical companies. However, the technology base can only be strengthened when technological developments in the country are able to meet market demand.

Partnerships between academia and public and private sectors should be established to increase the rate of innovation and patent protection in Brazil and to master the scientific and technological knowledge in strategic areas to reduce the vulnerability of the National Health System.

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Only by collaborating will the country be able to establish a competitive industry for producing medicines for human use. However, biosimilars are not the only way to meet the needs of the population for expensive biological products. A country must be able to effectively develop technology to meet its needs and thus grow and leverage the competitiveness of its industry in the country and the world in order to facilitate economic and social progress.

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Carlos Morel and Dr. However, other terms are used for biosimilars in different countries.

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  • Peres, and Fermam, In: Moraes A. Advances in the production of human therapeutic proteins in yeasts and filamentous fungi. Nature Biotechnology, 22 11 , The Pharma Report Is the Drought Over for Pharming? Science, , Economic issues with follow-on protein products. MA, J.

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    The production of recombinant pharmaceutical proteins in plants. MDIC M, Castilho, L. Nature Biotechnology, 22 12 , ROCHE Biopharmaceuticals and biotechnology medicines: an issue of nomenclature. European Journal of Pharmaceutical Sciences, 15, Biopharmaceutical benchmarks Nature Biotechnology, 24 7 , E-mail: luciana.

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    E-mail: suzana eq. E-mail: nei eq. Servicios Personalizados Revista. Introduction The biotech industry is currently considered to be the most important source of new drug development, in addition to its role as a strategic social and economic sector. Volume of Biological Products Marketed The health sector requires innovation to progress. Scenario Production of Biosimilars Given this scenario for increasing the production of biopharmaceuticals, some companies may join the biotech market after the patents on innovative medicines expire if they have the resources and expertise to produce biosimilars.

    Biopharmaceuticals The original definition of biopharmaceuticals that was first agreed upon in the s describes biopharmaceuticals as belonging to a class of therapeutic products produced through biotechnology techniques, i.

    source link Technologies Employed for the Production of Biopharmaceuticals Unlike small molecules, which are normally synthesized in the chemical environment, most biopharmaceuticals are sufficiently complex to requiring their production in living systems, particularly by recombinant DNA technology. Method I. Selection of Biological Products Selecting the biological products of Brazilian interest occurred after defining the three major criteria.

    Evaluation of Patents After defining the targets of interest, the patents for selected organic products were analyzed to verify the possibility of producing them in Brazil and to evaluate the possibility of a future owner of the technology. Results and Discussion The biological products selected for this study are listed in Table 2. Table 2:The biological products selected for study The list of drugs from the centralized procurement specialist already lists the betainterferon drugs imiglucerase and infliximab.