Scale-Up Considerations for Biotechnology-Derived Products

The introduction of biologies as credible therapies is evidenced by the increase in the approval rate of biologies over the last two decades. This is in contrast to the decline in the introduction of new small molecules (Fig. 1). The market potential of biologies is also projected to grow exponentially over the next few years (Fig. 2). These are some of the many drivers for 

In the case of protein separation technologies, further scale-up or multiple cycles will be needed until these challenges of increased throughput from cell culture are successfully met, for instance with, the use of improved resins having much higher binding capacities combined with good resolution. 

General Considerations in the Development and Scale-Up of Cell Culture Processes 

One obvious reason for scale-up in biologies is to meet market demand. Usually, small lots of product are produced during early evaluation of the 

This decision to scale-up is usually made two to three years before the projected regulatory filing date for the approval of the product, which in turn means about three to four years before the launch of the product. This is why the decision to scale-up is in direct opposition to the process development timeline, and special care has to be taken when developing a process for biologies in order for manufacturing not to be limitation on product approval. 

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