Manufacturing platform technology

The nature and properties of a chug substance dictate the design of formulation composition and the choice of manufacturing platform technology. The most commonly used manufacturing platforms for solid oral dosage form include ... 

As discussed earlier, one of the most important quality attributes for low-dose dmg products is uniformity of dose unit. Usually, dose strength of a dmg product is important in selecting a manufacturing platform technology. A simple decision tree on platform selection according to dose strength is described in Fig. 2.3 and is discussed below. 

He has been responsible for pharmaceutical product development from exploratory development, preclinical, preformulation, and drug delivery platform technologies, formulation, process, and scale-up manufacturing toward commercialization. 

These issues are common to all low-dose chug products and independent of platform technologies used in manufacturing the products. Therefore, it is important to understand and evaluate the factors affecting these quality attributes during product development. 

Each manufacturing platform has unique characteristics and complexity in terms of unit operations. Table 2.6 presents a fairly comprehensive (but by no means exhaustive) list of unit operation, process parameters, and quality attributes. Since more than one platform technology can be used to manufacture a drug product, selection of the most appropriate manufacturing platform is affected by many factors, such as ... 

An approach adopted by many has been the development of platform technologies. The aims of such a platform include for example, the provision of technology required to generate cell lines with high cell-specific productivity, to ensure the selection of production cell lines that perform well in the desired production process, to develop cost-effective production media, and to provide high-yielding, efficient and cost-effective production and purification processes suitable for large-scale manufacture. 

Flexibility of Manufacturing System 499 6.2. Integration Platform Technology 516... 

Utilizing the properties of copper, two durable platform technologies woe developed [1,13] the first one plates cotton fibres with copper oxide (Fig 1, left panel) and the second one impregnates polyester, polypropylene, polyethylene, polyur hane, polyolefin or nylon fibres with copper oxide (Fig 1, ri t panel). The fibres can be cut into short staple or produced in filament form and texturized, if so desired. The product yielded is a fibre that can be introduced at the blendii stage of yam production or directly into a woven or knit product so that no manufacturing processes are changed. Woven and non-woven fabrics can be produced. 

The advantageous features of SDDs described above make them an attractive and broadly applicable platform technology for formulating poorly aqueous-soluble (BCS classes II and IV) compounds in a robust, scalable manner from very early development through commercial manufacture. 

Duflou, J., 2009. C02PE Cooperative Effort on Process Emissions in Manufacturing, Manufacturing Technology Platform (MTP). 

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