Process Development Activities

With reference to Table 12.7 [19], it was found that catalyst activity could be fully recovered repeatedly by vapor phase stripping with hydrogen at 250 ° C. In commercial 

The catalyst slowly deactivated during the cyclic operation and, after an extended period (two to four weeks), olefin breakthrough occurred during an alkylation cycle. At this point, the catalyst activity was fully restored by treatment with vapor phase H2 at 250 °C, as described previously. Even after this high temperature regeneration (FITR) procedure was carried out 15 times during a pilot run of more than six months with the same catalyst sample, catalyst activity could be fully recovered. A coke burn with air was not required. 

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Late Stage and Process Development Activities Charles G. Smith. 401... 

The Lab Chip instruments/methods currently commercially available generally have less resolution and are less sensitive compared to conventional CE-SDS methods. However, the high throughput of the Lab Chip technique makes it attractive for in-process monitoring during process development. The Lab Chip method is generally used for process development activities such as clone selection, cell culture process development, and optimization of the downstream purification process. 

Further optimizing the process on the larger scale to take into account issues whose influence could not easily be predicted during earlier process development activities... 

Even though the process development activities typically begin after the formulation has been developed, they may also occur simultaneously. The majority of the process development activities occur either in the pilot plant or in the pro-... 

Of course these pieces or steps begin in development with initial process-development activities and conclude with product commercialization. All pre-process validation activities—from the initial ranging studies to the process-specific validations—can be dubbed as PQ activities, since they create a certain level of comfort with the process. These activities typically involve more than three full-scale runs—the number usually associated with validation. How exactly does this work How can a qualification require more runs than a validation The answer is very simple validation includes qualification, which means... 

There may often be many unknowns about suitable manufacturing operation while in the midst of product and process development activities. For preparation of clinical materials, the product may be produced in-house or at a contract facility. There are multiple possibilities for manufacturing product on a commercial scale The product may be integrated into an existing in-house operation, manufactured at a yet unidentified... 

The process development activities based on the original PERC flowsheet have been beset with many mechanical and operational difficulties and it has not yet been possible to obtain a pure wood derived oil which is free of the anthracene start up oil. 

Process development activities to optimize rSLPI production for clinical trials were subject to time constraints. Subsequent to this production campaign, we are continuing to optimize the process for rSLPI, since it will be a commercially important product. It must, however, be recognized that process changes will be reviewed for their impact on the quality and efficacy of the final product. 

Both chemical and process development activities typically require that the drug candidate be prepared on a pilot plant scale. Although the batch size may vary depending on the drug substance requirements, these oper-... 

The third entry in Table I is "The monotonic recovery , implying that the interest in supercritical fluid extraction is again increasing. Although the less than lustrous performance of supercritical fluids in energy reduction applications delayed or reduced other process development activity, currently there is increasing activity in supercritical fluid extraction. The resurgent interest resides in a n imber of factors, e.g.. 

Process development activities are planned to run parallel to each other to the greatest extent possible. Standard operating procedures, guidelines, and protocols need to be in place for aU key activities, from lab scale until commercialization. The activities are micromanaged through project management tools. In this section we discuss various key factors associated with process development and their impact on the product quality and yield. Instead of discussing the complete synthetic sequence of any particular product, we illustrate typical problems that could arise in any development process with real-life case studies from our experience. 

A major part of the process development activity for a new plant is to minimize, or ideally prevent by designing out, waste production and hence possible pollution. The economic and environmental advantages of this are obvious. 

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