Production platform technologies

BioVentures products and services oriented to the genomics research consist of a technological product platform composed by ... 

Although proteins can be expressed in many heterologous production systems, including bacteria such as Proteus mirabilis [1], fungi such as Pichia pastoris [2, 3] and Aspergillus awamori [4] and insect cells [5, 6], the pharmaceutical industry has narrowed down process development to a small number of platform technologies ... 

M. Hampton-Smith, P. Atanassova, P. Atanassov, and T. Kodas. Manufacture of electrocatalyst powders by a spray-based production platform. In Handbook of fuel cells Fundamentals, technology and applications. Vol. 3 Fuel cell technology and applications, ed. W. Vielstich, H. A. Gasteiger, and A. Lamm, 497 (2003). New York John Wiley Sons. 

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. 

Membrane technology for natural-gas separations is gaining broad acceptance and a number of major membrane-separation plants have come into operation in recent years. These include the Cakerawala production platform (CKP) that processes 700 MMScfd with a 37% C02 feed and a plant in Qadirpur, Pakistan that processes 500 MMscfd of 6.5 mole% C02 feed to 2% C02 pipeline specification [26]. Current plans are being made to double production at the CKP facility [27]. 

In view of current state of the art, namely, silicon-based technology, molecular electronics definitely exceed the expectations of a single product line. Going back, for instance, to 1960 silicon-based electronics were nearly exclusively considered as a simple replacement for the vacuum tube. However, it would have been myopic to limit the potential of silicon in that field of research. In fact, silicon constituted a technological platform, which evolved into the development of various products, most of them unfathomable at the time. Similarly, molecular electronics may be considered as a platform technology, rather than a single product line, which may give rise to many industrial products which are currently unforeseeable. 

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 ... 

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. 

If dose strength is less than 0.5 mg, direct compression or roller compaction may present significant challenges in achieving acceptable product content uniformity. In this case, explore other platform technologies. 

Many firms use product platforms. The idea is most obvious for companies producing devices. You may have noticed that a company like HP (Hewlett Packard) has new printer models every few months. They manage this by having a basic technology that is modified each time to suit new customers. Car manufacturers use similar tricks. Modifications (add-ons) can be made much more quickly and cheaply than a new platform - and such renewals are important for marketing. 

---