Despite gaps in the overall translation of established Lean and Six Sigma frameworks to this industry, potential applications of operational excellence to biopharmaceutical processing are significant. Direct applications have been limited by perceived inflexibilities such as product complexity, regulatory requirements, and requirements for high quality. In this article, examples of how operational excellence has been applied to well-known and commonly discussed bioprocessing bottlenecks are presented and linked to operational excellence concepts and overall goals. Additional opportunities for broader application are also presented.
It has been said that as little as 4% of any business causes half the waste, rework, and lost profit.1 This could also be said of biopharmaceutical processing. Process deviations and failure rates can be as high as 5–10%, requiring additional resources for discard, rework, or reprocessing,2 as well as associated investigations and corrective actions. Quality control of process and product conformance has at its core doing the correct action properly only once.
In spite of this, the uptake of operational efficiency programs (i.e., Lean and Six Sigma) in the biopharmaceutical industry has been slow compared to other industries.3 This is largely owing to perceptions that operational excellence is not amenable to the industry and because of a lack of successful, documented applications.4 Substantial cultural differences also suggest that experiences from outside the biopharmaceutical industry are not always relevant to improving bioprocessing operational excellence.5
Thus, there is a need to understand how to implement these programs in the biopharmaceutical industry. Improving efficiency could help the industry deal effectively with cost pressures owing to outsourcing, competition within therapeutic areas, competition from generics, and depleted pipelines.5,6 This article explains the major concepts of operational excellence programs, provides examples of how these methods have been used successfully in the industry, and suggests additional opportunities for their application.
Sample Calculations of Operational Excellence
KEY OPERATIONAL EXCELLENCE CONCEPTS AND HOW THEY APPLY TO BIOPROCESSING
The best known operational excellence programs, Lean and Six Sigma, both include key concepts that can be readily applied to biopharmaceutical processing. The sections below outline these concepts and provide examples of their application to the industry. For an explanation of how to calculate the operational excellence level (also known as the capability index, Cp), of a given process, see the box "Sample Calculations of Operational Excellence".
In Lean processes, each step must be:
- value-added (cannot be deleted),
- capable (free of defects),
- available (able to operate when needed),
- adequate (not a bottleneck), and
- flexible (used for many products within a product family).7
This method also identifies seven wastes: overproduction, excess inventory, waiting, transportation, motion, over-processing, and defects/errors. An eighth waste sometimes is added: underutilized employee talents.