Product and process development

Notification processes hinder new product and process development Potential for reducing costs... 

Active catalyst sites can consist of a wide variety of species. Major examples are coordination complexes of transition metals, proton acceptors or donors in a solution, and defects at the surface of a metallic, oxidic, or sulphidic catalyst. Chemisorption is one of the most important techniques in catalyst characterization (Overbury et al., 1975 Bartley et al, 1988 Scholten et at, 1985 Van Delft et al, 1985 Weast, 1973 and Bastein et al., 1987), and, as a consequence, it plays an essential role in catalyst design, production and process development. 

From the product and process development points of view, problems frequently encountered are ... 

Contrary to the commodity chemical business, the key to win in the specialty products market does not lie in squeezing out profits by means of economies of scale or process optimization. Rather, it lies in the ability for fast new product launches in order to capture the largest market share as soon as possible. Since superior product quality and performance is what really differentiates one specialty product from another, the product properties need to be adjusted as required by business needs. For example, the ability to manipulate functional chemicals in detergent products such as enzymes and zeolites, as well as backbone chemicals like surfactants, is often the key to success for both the detergent manufacturers and chemical suppliers [3], This trend has created an urgent need for an efficient and effective product and process development for these products. 

Atlanta, Ga., 26th-30th April 1998, p. 1842-9. 012 PRODUCT AND PROCESS DEVELOPMENTS IN THE NITROGEN AUTOCLAVE PROCESS FOR POLYOLEFIN FOAM MANUFACTURE Eaves D E Witten N Zotefoams pic (SPE)... 

In the author s opinion, the situation just described is not an unavoidable consequence of the intrinsic complexity of pharmaceutical products. In fact, other industries with products that are equally complex (e.g., microelectronics) have developed and implemented predictive methods for product and process development, optimization, and control, capable of much higher quality standards (as defined by allowed variability in product functionality) than the pharmaceutical industry. Rather, current practices in the industry... 

Fortunately, as this chapter is written in January 2005, product and process development in the pharmaceutical industry appears to be entering a period of deep transformation, initially driven by recognition at the FDA that a higher technological standard was a desirable and achievable goal, and fueled by an intense desire for improvement on the part of many industrial scientists and engineers. 

The chapter is organized as follows. First, to establish a common language, we define some common terms from both a pharmaceutical and an engineering perspective. Subsequently, we review model-based design and optimization as a framework for product and process development and optimization, process scale-up, and continuous improvement activities. The role of process and analytical technology (PAT) methods and principles in this framework is discussed. Finally, the main areas requiring effort are identified. 

Much of the data developed during product and process development is often empirically derived and, as such, reflects the relative experience and preferences of those responsible for that development process. While application of such experience can be of tremendous value, it is not unusual to find that each new product that is being developed, or process refinement being employed, has inherent idiosyncrasies that reduce the relevance of prior experience. In order to create a robust product and process, personal bias has to be removed, and, instead, decisions must be made based on scientific validity. All too often, the phrase we have fully optimized the product and process is used to describe a situation where decisions have been made on the basis of an iterative process where process (and formulation) variables have been studied in a trial and error manner, changing one parameter at a time. This process, often called one of successive approximation, is followed until an acceptable process has been achieved. The problems associated with employing such techniques include ... 

Thus, during product and process development, even though compression batch weights are often defined in terms of the capacities of blenders, granulators, dryers, etc., there is sufficient justification, when the product is to be coated, to keep in mind the capacities of the coating pans that will be used. 

The concept of validation should be incorporated during every phase of product and process development ... 

In summary, process capability studies start in the development laboratories and/or during product and process development, and continue in well-defined stages until the process is validated in the pilot plant and/or pharmaceutical production. 

Adherence to GMP in general and, as part of it, proof of validation of critical processes and its documentation are generally seen as topics under scrutiny during inspections. The documentation of qualification and validation exercises during product and process development inevitably encompasses hundreds if not thousands of pages. It would seem obvious that it is not in the interest of... 

Applications of biocatalysis in large-scale processes in industry advance only slowly against established chemical processes, even with stoichiometry-based chemistry. Introduction of biocatalysis into existing processes often requires process modifications that are not economical in view of the short life span of the product and/or the low fixed costs of the existing process owing to written-off plant. It should be emphasized that the desire to reduce chemical wastes, imposed by either company policy or governmental measures, needs to be matched by favorable process economics. Therefore, the introduction of biocatalytic options at the very beginning of product and process development is of the utmost importance. 

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