Today’s pharma and biotech companies have encountered many years of high drug discovery and development costs. As such, it is tempting to think that a comprehensive, ‘one size fits all’ manufacturing approach is the most effective route to take. But as we will see, this is rarely the best way to achieve both manufacturing and drug product excellence. To help explain the reasons why this is the case, it is important to first have some common understanding of sample directions where the industry is headed today. 2018 was a record year with sixty-one drug approvals by U.S. regulators. Going into more detail, a recent Forbes article highlights the fact that 74% of these drug approvals were actually for smaller companies, and that 60% of these had never before received a new drug approval. Meanwhile, approvals for the drugs of Big Pharma dropped to 26% as compared to 35-40% ten years prior. And, while novel therapies can bring significant potential and new opportunities for drug companies, they must oftentimes realize accelerated development and manufacturing cycles in order to succeed in this business sector. This demands rapid, flexible and reliable processes which, depending on the resources available, are either internally or externally supported. Together with the increased targeting of drugs on smaller patient groups, the complexity of developing and manufacturing such novel therapies also grows. In 2018 more than half of the approved new molecule entities target orphan indications including cancers, metabolic diseases, blood diseases, nervous system disorders and infection diseases. One quarter of the approved drugs had breakthrough designations. However, never mind in which specific business field a pharma or biotech company is active—whether it is more the established therapy sector or the rare disease field—it is critical to create both a solid drug development strategy and a contemporary manufacturing strategy. To effectively create them, getting it “right first time” might be decisive. Right from the start, before entering the first in-human phase I trials, a well-planned manufacturing strategy should be implemented. To create a solid basis for defining such a strategy, the following aspects illustrated in Figure 1 must be determined. Defining the right manufacturing strategy is strongly dependent on the company size and philosophy as well as available capabilities. Thus it differs for small, medium and large size companies. What are some major factors to consider?

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• Process

• Contract Pharma

• 5/1/2019

• Article