Commercial production trials

Commercial production trials comparing SPF and non-SPF stocks were conducted by the US industry. Biosecurity protocols were developed and implemented to prevent disease contamination of the SPF broodstock in order to produce Ffigh Health PL (Jaenike et al, 1992). More than 50 million High Health PL were produced in 1991 and stocked into commercial US ponds for field trials of the new stock. High Health PL-stocked ponds were found to be more than twice as profitable as the non-High Health crop. More uniform harvest-size distribution was seen in the High Health crop (Carpenter and Brock, 1992). More uniform-sized shrimp at harvest translates directly into improved profitability. 

Synthesis. One consequence of the discovery of the carbapenem natural products has been the development of new synthetic methods, the impetus for which was provided by the exceptional antibacterial potential of the compounds coupled with the extremely poor fermentation yields. Only chemical synthesis could provide the quantities of MK 0787 (18) necessary for clinical trials and commercial production. 

The RAC and processed commodities to be collected for each crop are listed in OPPTS 860.1000. Close attention should be paid to the definition and description of many of the commodities listed in the footnotes to Table 1. Reviewing a summary of the actual commercial processing practices for the crop may be helpful. Once the processing procedures and the agronomic practices to be simulated in the field residue trial are understood, a field study can be designed that will truly represent commercial production and processing practices. This will ensure that the study will yield useful, reliable, and accurate data to be used in the tolerance setting process. 

Major registrants typically conduct as many residue trials as possible on their own research farms and contract the remainder to independent contract research companies. These contract research companies range in size from those that have several research farms to husband and wife teams with only one site. They also may include independent researchers who do not own a permanent test site but contract small plot test areas from farmers inside commercial production acreage. The goal of these trials is to conduct the smdy in a cropping system environment that represents commercial production systems, thereby ensuring that the raw agriculture commodities harvested represent commercially available commodities. 

Figure 4.9 Scale-up of proposed biopharmaceutical production process to generate clinical trial material, and eventually commercial product. No substantive changes should be introduced to the production protocol during scale-up...

One plant demonstration, which began operation in August 1997, has been completed. The plant achieved an electric efficiency of 40% LHV. Ballard is in the process of securing plant orders to field test additional plants. Ballard expects field trials from 1998 to 2001 and commercial production of the plant with the characteristics listed above in 2002. Partners are GPU International, GEC Alsthom, and EBARA Corporation (15). 

The fuel cell itself liberates heat that can be utilized for space heating or hot water. The reference article did not list any operating conditions of the fuel cell or of the cycle. The PEFC is assumed to operate at roughly 80°C. Another recent article (49) published by Ballard shows numerous test results that were performed at 3 to 4 atmospheres where fuel utilizations of 75 to 85% have been achieved. Performance levels for an air fed PEFC are now in the range of 180 to 250 mW/cm. Ballard Power Systems has performed field trials of 250 kW systems with select utility partners. Commercial production of stationary power systems is anticipated for the year 2002. Similarly sized transportation cycles also are anticipated for commercial production in the same year. 

Although they obtained patents on the use of MDA for these applications (and also as a weight-loss product), they never developed commercial products from the compound. The problem, which appeared during human trials, was that the psychic effects on subjects were too severe to permit use of MDA for its intended functions. The compound caused overstimulation of the CNS, which sometimes resulted in panic attacks among subjects. This drawback did not, however, prevent the spread of MDA in the illicit drug market, where it eventually became one of the most popular substances used in the 1960s, when it was widely known as "the love drug. ... 

Extensive early development work is thus essential. Any significant deviation from the production protocol, used to generate the trial material, could invalidate all the clinical trial results with respect to the proposed commercialized product (changes in the production process could potentially change the final product characteristics — both the active ingredient and contaminant profile). 

Establishing measures of cGMP for the production and distribution of clinical trial material this may be different from the commercial production systems and addresses the issues of sta-... 

It is a cGMP requirement (21 CFR 211.25 a, b) that personnel have education, training, or experience that enables them to perform their assigned task. These training records should include the training curriculum for each individual, as well as the list of completed courses. These records should be made available for all personnel who manufacture, process, package, test, or release clinical trial materials and the commercial product. Firms are... 

The ultimate proof that the EPR method is useful for the identification of irradiated food is its performance in blind trials. A number of studies have already been completed (Table 5), and the results have been very encouraging. In the majority of cases it has been possible to identify foods treated with irradiation at doses well below those likely to be used commercially. In trials reported by Desrosiers etal., 1990, Scotter etal., 1990, Desrosiers, 1992 and Schreiber etal., 1993 all irradiated and non-irradiated samples were correctly identified. In the more extensive trial reported by Raffi etal., 1992, the numbers of correct identifications depended on the foods examined and the doses applied. In this trial the results for meat bones, dried papaya and dried grape were good but those obtained with fish bones and pistachio nuts were not as conclusive as the results from the trial reported by Schreiber etal., 1993. However further development of the protocols involved with these products has been undertaken and the results from future trials on these products should be more acceptable. 

Methadone is a synthetic opioid narcotic, discovered in Germany in 1939. Its original name was Ami-don, and it was used mainly as a pain reliever. After the conclusion of World War II, Eli Lilly and other American pharmaceutical companies began clinical trials of the medication, renamed methadone, and also began commercial production. Its original uses in the United States were for pain control and as a component of cough medicine. 

---