Since its full-blown development by Toyota beginning in the 1950s, lean manufacturing has been successfully implemented in various other manufacturing industries. Despite demonstrable success across several sectors, lean manufacturing solutions have been slow to take hold in the biopharmaceuticals field, and where they have, it has been just a tenuous hold. Some analysts and consultants think it’s time for that to change.
In an article titled “Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing” (BioPharm International 22.10, October 2009), Thibaud S. Stoll and Jean-Francois Guilland state early on that “direct applications [of lean manufacturing solutions] in the field of biopharmaceutical manufacturing have been quite limited to date because of concerns about the complexity of the associated technology and stringent regulatory requirements.” But they also maintain that “implementing LEAN the proper way in biopharmaceutical manufacturing can bring huge benefits and help the industry to deal with increasing pressure on development and manufacturing costs, as well as with challenges in compliance quality.” Then these authors adduce two case studies to support their case.
One of these involves a lean manufacturing implementation in a “large-scale cell-culture facility, with three independent manufacturing lines using 3,000-L and 10,000-L bioreactors. The facility is used to produce clinical active pharmaceutical ingredient (API) material, primarily for Phase 2 and Phase 3 trials, of various biopharmaceuticals in development.” This plant also conducts technical development in adjacent labs.
After an initial assessment by lean manufacturing consultants to determine the primary problem areas where improvements could be made, specific projects were clearly defined and steps delineated. Two of the major goals, along with practicable metrics, in this implementation were increasing throughput rate and decreasing throughput time. The results in increasing throughput rate alone were very impressive.
Throughput, naturally, can be influenced by a host of factors. In this facility, however, it was determined that changeover activities had the greatest (negative) influence, and so the job was to improve both batch-to-batch and product-to-product changeover times. Nearly “27% of the total yearly plant capacity was lost as a result of changeover activities.” So a goal was established to reduce this capacity loss to less than 10%. And, ultimately, that goal was far surpassed, with yearly capacity loss owing to changeover activities reduced to less than 3%.
“To achieve this result, each individual task performed during the changeovers was evaluated, focusing on possibilities and consequences to shorten them, cancel them, or schedule them differently.” The tasks and changes were then sorted into categories, and those that would allow the “most significant improvement” in changeover time were concentrated on. The chief Lean changes implemented to improve changeover times involved radically optimizing “cleaning-in-place and steaming-in-place operations,” accelerating some testing procedures, and accelerating probe calibration.
Waste in the form of waiting (lost capacity) resulting from changeovers was thus largely eliminated. Changeover times were shortened, maintenance activities were streamlined, and “the proportion of the yearly plant capacity available for production was raised from 68.4% to 94.9%”
Here is remarkable proof, then, that eliminating waste and improving productivity is possible even in biopharmaceutical manufacturing. With qualified lean manufacturing consultants to assess and guide the implementation of Lean solutions, companies can look forward to improving profitability and gaining a keener competitive edge.