Investment timeline

Method qualification is based on ICH method validation guidelines. Method type (purity or identity) will dictate the level of qualification testing necessary. Several strategies for method qualification and validation exist and are based on needs, resources available, and the project timeframe. One approach is to perform minimal development and qualification, which may be necessary for projects with shorter timelines, but it may place more burden and risk on future validation activities for robustness testing, and can result in failure. As discussed in Chapter 4, an alternate approach would invest more time and resources into method development, followed by extensive qualification and robusmess testing to determine if further development is... 

By developing a series of generic host production organisms, fermentation development time can be minimized when these host systems are used for production of multiple products. The investment of time and resources in developing the initial fermentation and recovery system can be recovered in subsequent programs in the form of more rapid commercial development timelines. 

Marathon s strategy was to leverage future clean fuels projects to minimize capital investment and maximize emission reductions. Units with feed hydrotreating capacity typically used catalyst additives. Units with no hydroprocessing typically relied upon other technology options in conjunction with catalyst additives. Since each application was unique, implementation was required over a period of time. Figure 14.5 shows the timeline when significant events occur for the Marathon CD. 

Increased market pressnre on innovator pharmaceutical companies to rednce costs of prescription medications and simnltaneonsly rednce the time to bring new medications to market has had a tremendons impact on bnsiness development. In addition, the rate of drug candidate attrition has altered the research and development (R D) investment paradigm to minimize development until proof of clinical viability has been demonstrated. These internal pressures are driving fundamental changes in process chemistry to streamline timelines without the added cost. 

Easier to manage timelines for expected returns on R D investments. 

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