What are some of the decision-making tools that would allow you to move from batch processing to more continuous drug substance manufacturing?

Over the last few years and especially after the emergence of COVID-19, interest in this topic has increased significantly. Companies are looking for ways to respond to needs from existing customers but also prepare for the expanding requests from new clientele. Also, COVID-19 has opened lots of eyes to the fact that proactiveness needs to be an innate part of the manufacturing process.

Transitioning from segmented or batch processes to more continuous manufacturing is making sense in more ways than none.
Key players such as Pfizer, Eli Lilly, Lonza, GSK, Sanofi-Genzyme, and others have been investing in optimizing continuous drug substance processes to help lower overall costs (understandably) but also to improve:

• Quality assurance (which includes minimalizing process variability, identification and removal of non-conforming material, know-how regarding implementation of advanced process controls.
• Greener protocols and workflows
• More efficient and safer operations
• And more succinct compliance with regulatory bodies (i.e.,
  upgrading equipment or modernizing the overall workflow)

The reason for all of this is to bring additional value in the form of agility and time savings, flexibility, and efficiency. This helps lower costs certainly but can also make products and services from these companies more readily available.  

Some of the apparent challenges to implementation of a continuous drug manufacturing process are increased costs for materials and personnel, limited personnel (something that has seemingly been exacerbated after the onslaught of COVID-19), limited resources for training, lack of experience with or intimidation regarding regulatory adherence, forced external sponsorship, and others. These are not only challenges but barriers to optimization.

Are you familiar with continuous manufacturing processes? What ways are you involved with its implementation? What’s working well for you?

Source: Luciani, C. (2022, April). Modeling & Simulation as Decision-Making Tools for Drug Substance Continuous Manufacturing. American Pharmaceutical Review, 25(3), 26–29. 

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