Optimizing Biomanufacturing Capacity and Flexibility

By: Nick Hutchinson

Applying the “Lean Lens”

Jessica Morse (Amgen) spoke on ‘Optimizing capacity and flexibility in the Amgen, Rhode Island manufacturing plant’ at the BioProcess International Conference & Exhibition, 2016. The Rhode Island facility has been operational since 1986 and was originally a single-product facility for the production of Embrel. Now the facility produces multiple products for both commercial and clinic supply. Amgen’s projection for their future product requirements requires that the plant will need to increase its output. Previous projects have optimized bioreactor titers but now the company is seeking ways of using their time in the facility more effectively to increase productivity.

Reducing facility downtime

In the past, Amgen would shut down the Rhode Island facility for 30 days each year in order to perform maintenance operations. Now the company uses shorter facility shutdowns that it is able to fit into their normal production plan. This is reducing, even eliminating the need for the 30 days annual shutdown and allows Amgen to use a greater amount of facility time for producing batches of product. The company has analysed the risk of not performing non-value adding maintenance activities and are applying the philosophy that “if it is not broken, don’t fix it”. They have applied a science-based equipment maintenance program to ensure they are focusing on the right preventative maintenance activities.

Debottlenecking the facility

Amgen have adopted a methodical approach to understanding and responding to debottlenecking opportunities within the plant. They are adopting a phased implementation approach to debottlenecking activities to increase plant utilization over the upcoming years. The company is accelerating its run rate through activities such adding additional equipment and the strategic use of single-use technologies

Reducing waste

Staff working at all levels at the Rhode Island facility are empowered to make the incremental changes that can transform the operation of the business. Empowered employees are enhancing existing practices and contributing new, breakthrough ideas. The company is focusing on reducing waste by reducing error and eliminating non-value adding work. Morse gave three examples of improvements that employees have contributed using this type of thinking. Firstly, the site is using a drone to perform inspections of high risk areas (also improving safety), secondly they have developed a customized cart to streamline filter integrity testing and thirdly, they have implemented a ‘parts cart’, which they use to organize parts thereby reducing motion and waste.

Morse also described how the site has installed drum tippers to eliminate hand scooping for the dispensing of powders. These are making it easier to charge buffer and media tanks during solutions preparation operations.

An alternative approach Amgen is using to reduce waste is to improve their right-first-time performance and avoid having to perform rework. They are improving operational execution and new product introduction readiness by running virtual batches in which process experts run through batch documentation and ensure that errors are corrected before the batch is run in earnest. The company implements the lessons it learns from previous new product introductions and has developed product-focussed training for staff. These activities are reducing the number of non-conformances per lot associated with newly introduced processes. In some cases, the company is able to eliminate engineering runs, freeing up additional time for extra production batches.

Amgen’s culture of continuous improvement and innovation is helping the company to improve efficiency and increase its production output at the Rhode Island facility.

 

About the author: Nick Hutchinson is a Technical Content Marketing Manager at Sartorius Stedim Biotech.

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