Imagine this: Months of troubleshooting has finally led you to a successful lysing method for your cell of interest. Yet after trying to take that method large-scale, your heart sinks when you realize that your perfect method no longer works outside of the small-scale setting. This is the unfortunate reality for many scientists, particularly those involved in small-scale R&D as well as large-scale manufacturing. Read on for important criteria about scalability, specifically related to cell lysis.
The term scalability can be thought of as the ability of a system or method to adapt to increased demand. In the context of drug development, a method is scalable if it does not need to be altered when translated from R&D to clinical trials and then to manufacturing. (1) Particularly in the research industry, scalability is a critical factor to consider for two central reasons:
- Cost efficiency - Whether you are an independent lab, in-house, or contracted by a large corporation, conducting research is expensive, particularly in the R&D industry. Scalability of a method ensures that you can invest in a project with confidence that it won’t outgrow its original system. Alternatively, if the method was not scalable, you would be delegated back to ground zero to begin again; this would result in a huge monetary loss.
- Time efficiency - Significant amounts of time can be saved by developing a scalable method from day 1. The alternative would be re-doing projects that may have taken many months to complete.
In addition to considering method scalability, equipment choice plays a significant role in successful translation of small-scale production to large-scale production. For example, microfluidizers are frequently used to effectively disrupt cells. Many companies that produce this equipment advertise the scalability of their products.
Homogenizers are an alternative to microfluidizers, and can additionally function to reduce particle size and synthesize products that are frequently used in the pharmaceutical, biotechnology, chemical, and food & beverage industries. A number of homogenizer makers have available different models for each phase of drug development; for example, Pion's BEE brand is renowned for our homogenization equipment and ability to help a customer through the drug development process. We offer laboratory homogenizers for R&D, pilot scale homogenizers for clinical trials, and industrial homogenizers for the manufacturing phase. The scalability of these homogenizers- e.g., a method that was successful with the laboratory homogenizer will also be successful with the industrial homogenizer- is a huge benefit that can save both time and cost.
When selecting a company that offers scalable cell lysis equipment, begin with Pion; not only do they offer high quality equipment, but they also offer customizable equipment and proprietary software to help optimize processes.
