Examples of Lean Manufacturing Success in biopharmaceuticals


The full-blown development of Toyota beginning in the 1950s, lean production has been implemented in various other sectors of production. Despite demonstrable success across several disciplines, have lean manufacturing solutions have been slow to take hold of the biopharmaceuticals field, and they have, it has been only a slight hold. Some analysts and consultants believe it is time for that to change.

In an article titled “Harvesting the benefits of LEAN in Biopharmaceutical production” ( Biopharm International 22:10, October 2009), Thibaud S. Stoll and Jean-Francois Guilland state early on that “direct application [lean manufacturing solutions] in the field of biopharmaceutical production have been quite limited to date due to concerns about the complexity associated technologies and strict rules. ” But they also claim that “the implementation of Lean in the way in biopharmaceutical production can bring huge benefits and help the industry to deal with the increasing pressure of development and production costs, as well as the challenges of consistent quality.” Then these authors refer two case studies to support its case.

One of them involves the reduction of production implemented in “large-scale cell culture facility with three independent production lines with a 3000-L and 10,000 L plant is used bioreactors. To produce clinically active pharmaceutical ingredient (API) materials, primarily for Phase 2 and Phase 3 studies of various biopharmaceuticals in development. “This plant also conducts technical development in adjacent labs.

After the first evaluation lean manufacturing consultants to determine the main problem areas where improvement is made specific tasks were clearly defined and steps defined. Two of the main objectives, along with realistic statistics, this practice was increasing throughput rate and decreasing throughput time. Results in increasing throughput rate alone was very impressive.

capacity, naturally, can affect a number of factors. In this situation, however, it was decided to divide the activities had the greatest (negative) impact, and the job was to improve both batch-to-batch and product-to-product transition period. Nearly “27% of the total annual processing was lost because of the change activity.” So the goal was established to reduce this capacity loss to less than 10%. And, finally, the goal was far, with annual capacity loss due to the change operations decreased to less than 3%.

“To achieve this result, each individual task performed on changeovers were evaluated, with a focus on the possibilities and consequences to shorten them, cancel or schedule them differently.” The projects and changes were then classified into categories, and those that would allow “most significant improvement” in the amendment, were concentrated on. The chief Lean changes implemented to improve the transition time involved radically tweak “cleaning-in-place and steam-in-place operations,” the speed of some test methods and speed probe calibration.

Waste in the form of waiting (lost capacity) due to changeovers was so mostly out. Transition time was shortened, maintenance operations were streamlined and “percentage of annual processing system available for production was increased from 68.4% to 94.9%”

Here is a remarkable proof, then, that eliminating waste and improve productivity is possible, even in biopharmaceutical production. With increased lean consultants manufacturing to evaluate and manage the implementation of Lean solutions, companies can look forward to improving profitability and achieving a sharper competitive edge.


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