Scale-up refers to an increase in batch size. For example, if a drug is successful, it may scale up multiple times throughout its life cycle to meet growing demand. Eventually, scaling down may also happen in response to the shrinking drug demand.
Product evolution and scale-up should be considered as early as possible in the research and development phase. Any processes involved in fabricating the drug must be scalable regarding safety and efficacy, with economic factors also to be considered.
The terms “scale-up” and “scale-down” describe the increase or decrease in a manufacturing process.
Know the Different Scales and Why They Matter
Pilot-scale batches are intermediate-size pilot batches made to test the characteristics of a drug before going into full-scale production. Pharmaceutical companies conduct pilot-scale manufacturing to determine if a drug will work and be safe for human consumption. Commercial-scale batches are the standard size batches produced once a drug has been approved for production and released onto the market. If demand increases, the production process may be expanded to other facilities and, in some cases, to other countries.
The Ultimate Guide to the Elements of Scale-Up
When a contract manufacturing organization (CMO) is not already involved in developing a pharmaceutical drug, it will likely be involved in scale-up and post-approval change (PAC) activities. If a CMO is involved in R&D activities, it will be primarily engaged in a product profile definition, including critical quality attribute (CQA) identification, during the product profile phase. CQAs are biological, microbiological, and physical attributes that can be measured and defined for a drug to monitor and control quality. During the process development phase, appropriate manufacturing equipment is selected by completing a Scale-U and Post Approval Changes report to confirm, for example, that the right equipment has been chosen.
What are the Challenges R&D Pharma Should be Aware of in 2022?
There are multiple approaches to scale-up, including the more involved Quality by Design approach and the more minimal End-Product testing approach. Each poses challenges for the scale-up of a drug. When those involved in R&D pharma understand the challenges associated with each, they are better engaged to make informed decisions about how reasonably to respond to them when considering scale-up issues.
When considering whether or not to make a drug commercially available, one must consider whether the process used in making the drug can be scaled up to large volumes of production. Similarly, if special equipment is needed in the laboratory to make just enough for research purposes, it would be necessary to have comparable equipment available commercially.
Manufacturers may want to consider that changes in the manufacturing process can affect the purity profile of drugs, which can pose a challenge for safety studies done previously. A qualified CMO may be able to support the approach to these challenges and will be interested in keeping processes economical and efficient.
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