Marketed biopharmaceuticals, improving

Cost-effective technologies have been gaining importance in the last few years due to the expiration of patents of the first-generation biopharmaceuticals (Table 16.2). In the past, the concept of time-to-market dominated the industrial arena. Nowadays, companies are willing to focus on process optimization and cost reduction. Important tools for this purpose are the use of advanced genetic manipulation techniques to increase the cell specific productivity, as well as the development of perfusion processes, to increase volumetric productivity, and more efficient purification processes, to improve yield (see Chapters 3, 9, 11 and 12). 

Pharmaceutical excipients available on the market seem sufficient to support typical oral solid dosage form development. In some cases, new chug candidates have physicochemical and biopharmaceutical properties that are less than ideal. These chugs present formulation challenges and may require either the discovery of new excipients or improvement of existing excipients. From a regulatory perspective, there is no answer for the question of registration of an excipient as a separate entity. 

Cassette Cassette products are widely used in the biopharmaceutical industry and specifically dominate the protein concentration purification market due to their compactness, which provides excellent product recovery capabUity. Cassette modules contain presealed flat sheet membranes separated by feed and filtrate spacers. This is an improved design compared to earher plate and frame configurations, making installation and replacement much easier and more reliable for the end user (shown in Figure 14.5). 

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