by akronbiotech

The problems that arise when scaling up from small research batches to pilot-scale production to large-scale manufacturing aren’t always what you might expect them to be. While the concentration of the components in the formulation may not change, plenty of subtle idiosyncrasies noticed in the research phase can become huge hurdles on the commercial end of production. Once a potential product begins to show promise in final testing, the desire to commercialize also ramps up quickly. It is important to identify and address the potential problems that may be exacerbated at larger scales prior to validation, rather than assuming that the process will scale up perfectly.

Figure 1. Process Scale Up

The obvious issues associated with scale up, such as equipment purchases, allocating space, and others can be mitigated through timely and effective planning. Other issues require a more nuanced approach. For example, it may seem obvious that a larger volume requires a larger and faster mixer to stir everything. However, one must consider how that new mixing rate affects the temperature of an exothermic reaction. These issues do not lend themselves to formulaic answers. Identifying and resolving them requires experience and know-how.

Akron Biotech has years of experience in process scale up. We can quickly recognize potential challenges that scaling a process may present, and then work closely and proactively with clients to identify and implement effective solutions, thereby providing a quicker route to market. During the engineering phase, these ideas can be verified to show that although small changes may have been made to the process, the final product is the same. Once this is proven, the original material identified by the research team may move forward to larger batches within a cGMP environment. For more information on how Akron Biotech can help scale up and lead your product into the realm of cGMP, click here.


        


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