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La recuperación de los materiales

In document I.- DISPOSICIONES GENERALES (página 90-97)

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CIÓN BUCIÓN DISTRI SUMO CON NACIÓN ELIMI

VII.2. Programa integrado de recuperación y eliminación

VII.2.1. La recuperación de los materiales

Automation has transformed drug development and discovery by making it possible to identify many targets with the aid of combinatorial technologies. Automating compound management processes, with the aid of high throughput screening (HTS), have helped avoid compound rejections. For drug discovery, the automation market has a vast array of tools to offer. With the high cost of bringing a drug to market, lab automation streamlines drug discovery and research labs’ processes, eliminates downstream bottlenecks and speeds target identification and screening.

Among pharmaceutical and biotechnology companies, automation is not necessarily implemented to reduce labor costs, but rather to improve experimental results and work flow. In drug development, scientists are testing many more samples in order to measure a drug’s characteristics. So the quality of results is crucial. Automation allows investigators to focus on analyzing results or developing new research avenues rather than the laborious and repetitive manual steps of an experimental set-up. Lab automation sales are heavily tied to life science spending, especially spending by the pharmaceutical and biotech industries.

Although drug companies have curtailed their spending in general, the demand for lab automation instrumentation has continued, although at a modified pace, in part because of new products and automated solutions for newer techniques, such as microarrays and cell-based assays. But spending in this segment of the laboratory automation market, while still healthy, will not be as significant as growth in the clinical segment of lab automation, as the drug discovery segment is closer to maturity. Moreover, HTS does not always lead to successful drug commercialization.

From the early 1990s, the starting point for lab automation involved the refinement of the microtier plate, a plastic sample holder with 96, 384 or even 1536 sample wells arranged in a two-by-three rectangular matrix. Providing a simple platform for performing assays on larger numbers of samples, microplates have been a major enabler of HTS, which was developed to screen large numbers of compounds as potential drug candidates for activity against a specific disease. These potential drugs form compound libraries, which are the intellectual property of the drug company performing the tests.

Before the advent of HTS, analyzing a maximum of 100 samples a day was not unusual. With HTS, much larger libraries consisting of at least 10,000 samples are routinely analyzed per day, making it more likely and cost effective to find positive

results in an assay, indicating the existence of potential drugs. The need for HTS becomes still clearer, when one considers that only about 250 compounds tested make it to preclinicals for every 10,000 screened. Of these, only about 10 make it into clinicals, and only one of the clinically tested compounds reaches market.

The screening of compounds by HTS is made possible by the use of lab automation systems. The first devices were pipetting work stations -- liquid handlers -- that exploit the microplate format. Before compounds can be tested, they have to be placed within the 96 or more wells of a microplate. This requires pipetting, a tedious, slow and error-prone transport of a measured amount of liquid, if performed by hand. With liquid handlers, on the other hand, it became possible to perform pipetting on a large number of individual compounds without human intervention, a necessary first step in the automation of assays.

Another device that facilitates HTS is the microplate reader, which determines whether assays are hits. Different types of microplate readers are on the market. These vary by detection technology -- absorbance, fluorescence, chemiluminescence, bioluminescence or radioactivity. Other HTS-enabling technologies include microplate washers, dispensers, sealers, bar code labelers, incubators and autosamplers. Even with the use of these devices, many manual steps remained part of the process. In the past, microplates had to be removed by hand from liquid handlers and new ones added. The need to eliminate these inefficient steps helped give rise to laboratory robotics.

Eventually, miniaturization is making possible greater densities in microplates. And automated storage and retrieval systems store library compounds as they wait for their next screening and retrieve them when they are ready for to be screened.

The world market for drug discovery laboratory automation systems will not fare as well as the market for clinical lab automation systems. This is in part caused by a market that has somewhat matured and which is essentially limited by the number of drug and biotechnology companies and their success in commercializing new therapeutics. This market is evolving into somewhat of an equipment replacement market, unlike the clinical lab segment, in which many labs are looking for new equipment. Still, the drug discovery segment for lab automation will experience a 3% to 4% annual rate of growth. Tables 4-13 through 4-17 indicate the expected growth in this market in the near term worldwide by geographical segment.

Table 4-13

World Market for Drug Discovery Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$3.24 $3.37 $3.50 $3.64 $3.78

Source: Kalorama Information

Table 4-14

North American Market for Drug Discovery Laboratory Automation Systems

2008-2012 Revenues (in billions)

2008 2009 2010 2011 2012

$1.79 $1.85 $1.93 $2.01 $2.08

Source: Kalorama Information

Table 4-15

European Market for Drug Discovery Laboratory Automation Systems

2008-2012 Revenues (in billions)

2008 2009 2010 2011 2012

$0.81 $084 $0.87 $0.91 $0.94

Table 4-16

Asian Market for Drug Discovery Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$0.32 $0.34 $0.35 $0.36 $0.38

Source: Kalorama Information

Table 4-17

Rest of World Market for Drug Discovery Laboratory Automation Systems

2008-2012 Revenues (in billions)

2008 2009 2010 2011 2012

$0.32 $0.34 $0.35 $0.36 $0.38

Source: Kalorama Information

In document I.- DISPOSICIONES GENERALES (página 90-97)