Lean Process Implementation for Biopharma Sites
With an alarming rise in coronavirus cases worldwide, there is a significant need for large-scale vaccine production and distribution. In this time of high demand, implementing lean principles into our manufacturing processes can ensure faster and smarter vaccine production.
Since the onset of COVID-19, numerous companies have entered the race to develop a vaccine against public enemy number one, coronavirus. Currently, there are more than 160 vaccines being developed; 26 are already in human trials.1 Considering the large-scale spread of the virus, and the alarming rate at which individuals are being infected, the need for a vaccine is exceptionally important. After the successful completion of clinical trials and consequent approval of the respective vaccines by the FDA, these companies are likely to scale-up vaccine production in an effort to meet these needs.
During this time of high demand, implementing lean principles into our manufacturing processes is likely to be beneficial, as it would facilitate a faster and smarter vaccine line of production. The Lean Six Sigma approach promotes continuous improvement by utilizing various tools to reduce or eliminate wasteful steps. The goal of this streamlining is to produce and deliver the highest-quality product with the least amount of time invested, cost incurred, and effort required. In order to understand how Lean Six Sigma tools can be used by these companies, it is important to first understand the vaccine manufacturing process.
Although the vaccine manufacturing process may somewhat differ based on the type of vaccine being produced, the overall process consists of similar steps. The process is initiated by the generation of the antigen, which induces an immune response, in a ‘master cell bank,’ from which working cells banks are prepared to be “used as the routine starting culture for production lots.”2 The antigen then needs to be isolated from its growth environment and purified before proceeding to formulation, wherein the components of the final vaccine are combined and mixed in a single vessel.2 Throughout the formulation phase, and the following filling operations, quality control (QC) testing is performed to assess the safety, potency, purity, and sterility of the particular vaccine.2
In order to more fully understand how these lean principles can improve manufacturing lines, we will examine the actual implementation of Lean processes at a global vaccine manufacturer’s new bulk manufacturing facility. This new manufacturing site was designed to incorporate Lean strategies, such as a single-direction material flow design, disposable technologies, and manpower reduction, among others.3 Upon further evaluation, senior management and experienced consultants also implemented plans to increase efficiency in their indirect operations. By reducing material costs and QC personnel, the facility benefitted from several improvements including the following: reductions in product testing requirements, decreased engineering efforts, fewer product rejections, improved production yields and enhanced process controls.3
This case study demonstrates that the implementation of a Lean Six Sigma methodology at facilities that will manufacture coronavirus vaccines is likely to improve process efficiency and lead to faster production. This increased speed and efficiency will make it much easier to meet the high demands in a timely manner. The single caution to implementing these lean strategies is related to the vaccine development process. Each site will need a level of individualization due to unique antigen generation, and the resulting manufacturing process tailored to that type of vaccine. Moreover, facility-specific factors such as inventory, non-essential personnel, production flow design, QC testing requirements and staff organization, may also influence what steps are taken to improve process efficiency. After this aforementioned tailoring, relevant Lean strategies can be implemented for these facility-specific factors and within each stage of the vaccine manufacturing process. This approach is sure to assist the companies that will soon be commencing large-scale manufacturing of the respective approved vaccines.