Biotech industry

The third category, cake filters, although well developed in many wastewater treatment applications, are the least developed of the filtration equipment use by the Biotech Industry. In the organic synthesis laboratory sometimes very simple equipment like a funnel and filter paper is used to accomplish this operation. Some other operations used for this filtration step in the lab are more sophisticated, but many are very labor intensive and limit the capacity of the overall production process itself. As a result, there is a need for optimization of the cake filtration equipment used in biotechnology. Cake filtration equipment is available in batch and continuous modes. Following are several examples of cake filtration units ... 

Since the late 1980s, computer-aided drug design (CADD) techniques have found wide application in the pharmaceutical and biotech industries. In the... 

The following sections of this paper examine the economic characteristics of the R D process in pharmaceuticals that make patents so crihcal. Sections 30.2 to 30.4 discuss the costs of innovation in pharmaceuhcals and the effects on innovative and imitative competition of the 1984 Hatch-Waxman Act. Section 30.5 considers whether the biotech industry is different from the pharmaceuhcal industry in terms of R D costs. Section 30.6 considers the distribution of returns on R D in these industries. The final section presents conclusions and policy considerations. 

Most of the analyses of R D cosfs for new dug entities and their generic imitators have focused on small molecule NCES. This reflecfs the relative youth of the biotech industry. New biologic entities were first introduced in the 1980s. By 1994, only 29 new biological entities had been introduced into the U.S. market, but this number has increased dramatically since then. In this regard, 41 new biological introductions occurred between 1995 and 2001. 

CE oligosaccharide analysis with APTS labeling has been used in biotech industry for many years and has demonstrated reproducibility. It is now routinely used in GMP environment for release of therapeutic proteins and antibodies. Figure 29 shows the reproducibility of the analysis. 

The robustness of an assay becomes critical when evaluating its performance in a QC environment for the release of therapeutic proteins and antibodies. Over the past 5 — 10 years of product release experience in the biotech industry, assay failure rate is in the range of 5—30% depending on the method type and system suitability criteria. The types of assay failure are mainly as follows technical error (including analyst error), equipment error, and system suitability/assay acceptance errors. A periodic review of an assay s performance in the QC labs and timely feedback to the development labs are crucial to minimize the assay failure rate. A concerted effort in working with vendor is also helpful to ensure that instruments are in good condition to minimize the assay failure rate. 

IMS Health (IMAP) (2010) Pharmaceuticals Biotech Industry Global Report - 2011. www.imap.com. Accessed 29 Sep 2011... 

The rate of biotech discoveries reaching the market needs to increase rapidly if the overall pharmaceutical pipeline is to grow. At the very least, however, the advent of the biotech Industry has greatly changed the face of pharmaceuticals worldwide, and may yet become - as has been touted for decades - the creative force that saves the pharma industry. 

Biotechnology for medical applications had become widely accepted and recombinant methods were familiar to most scientists working in the field. The first German biotech companies, the pioneers of the biotech industry in Germany, Qiagen (established 1984), Rhein Biotech (established 1986), MWG-Biotech (established 1990)and Evotec (established 1993), were struggling along. 

Jaffe, G. (2004a). Sowing Secrecy The Biotech Industry, USDA, and America s Secret Pharm Belt. Washington, DC Center for Science in the Pnblic Interest. 

Recent data and other scientific and engineering advances provide the potential for expanded opportunities in almost all separation technologies. Future separation needs are related to the pharmaceutical, biomedical, and other biotech industries, microelectronics, aerospace, and alternative fuels (i.e., hydrogen) segments of the economy. In addition, nanotechnology will impact separations in general with respect to scale and materials. Environmental concerns, such as CO2 levels in the atmosphere, will continue to provide the impetus for improved separation technologies. 

Achieving Compliance hfm Pharmaceutical) MeSicUffi and Biotech Industries... 

Validation standard operating procedures a step-by-step guide for achieving con5)liance in the pharmaceutical, medical device, and biotech industries / Syed Imtiaz Haider.-- 2nd ed. p. cm. 

Pharmaceutical, medical, and biotech industries are regulated worldwide to be in compliance with cGMP and GLP principles. Each company is required to create validation SOPs to qualify its equipment, utilities, buildings, and personnel. The template validation SOPs available enable end users to understand principles and elements of GMP and provide documentation language ranging from generic to specihc, depending on the detail level of the requirements. 

Figure 2 The biotech industry revenue projections. Source 2002 data from Ref. 2.

Stem Cells and Regenerative Medicine - SRI s Fourth Annual Meeting, Commercial Implications for the Pharmaceutical and Biotech Industries, Princeton, NJ, USA. IDDB MEETING REPORT 2004 October 18-19. 

Danzon, P., A. Epstein, and S. Nicholson. 2003. Mergers and Acquisitions in the Pharmaceutical and Biotech Industries. Social Science Research Network, 1-43. Available at http //papers. ssrn.com/sol3/papers.cfm abstract id=468301 [Accessed May 10, 2005]. 

The discovery of novel, small molecules through screening secondary microbial metabolites is still an important and fruitful activity in pharmaceutical and biotech industries. However, the isolation and structure elucidation of lead compounds is often a tedious and time-consuming process especially when the compounds being sought may only be present in infinitesimal quantities. When one considers, for example, that microorganism extracts have thousands of constituents, the difficulties in separating out one particular component can be appreciated. 

Following the success of recombinant proteins such as insulin, therapeutic mAbs today represent the second wave of innovation created by the biotechnology industry during the past 20 years. The recent success of a number of new mAb therapies, for example rituximab (Rituxan ) and infliximab (Remicade ), suggests a resurgence of the biotech industry for the coming years. For serious chronic diseases such as cancer or rheumatoid arthritis, mAb therapy has indeed proven its clinical efficacy. 

In 2002, mAbs represented -16% of the value of the total global biotech industry, with a rising tendency. 

Use the executive management review aspect of the quality system regulation as a quality guidepost within the pharmaceutical and biotech industries. 

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