Aligning Manufacturing and Business Strategies with Single-Use Systems - In this case study, the authors explain why Catalent decided to transition from stainless steel to single-use systems. - BioPha


Aligning Manufacturing and Business Strategies with Single-Use Systems
In this case study, the authors explain why Catalent decided to transition from stainless steel to single-use systems.

BioPharm International Supplements
Volume 25, Issue 11, pp. 42

Manufacturing strategy was an important factor for us. We had grown out of our current facility, but we were able to find a nearby site with a large open area with thirty foot ceilings. This area, an “ideal box,” required minimal demolition prior to building out suites, and also allowed us to have sufficient ceiling height to install bioreactors and other equipment. Single-use manufacturing had evolved rapidly since 2001 and was becoming widely accepted by our target segment. Even though we had six new stainless‑steel reactors, we decided to step back and objectively evaluate single-use technologies.

We weighed the options on both sides. Our stainless steel reactors were already purchased and we had vast experience with this technology. We also knew that our clients tended to be adverse to change (even positive change) because of the cautious nature of the industry, and that there may be concerns about transitioning processes traditionally conducted in stainless-steel to single-use technologies. Most of the facility and equipment cost savings of single‑use equipment was nullified because of our previous purchase of stainlesssteel reactors. In the end, however, we based our decision on how to provide a better service.

Catalent’s market research indicated that going forward, more products will require scales of less than 2000 L. In addition, the research showed that companies’ acceptance of single-use systems was significantly rising because of the associated lower facility and equipment costs, as well as the reduced effort in suite turnovers. For multiproduct facilities, single-use systems also offer the additional benefits of diminishing the risk of cross contamination and increasing throughput based on faster changeovers.

However, there are still risks in the adoption of a new technology for bioreactors, such as extractables and leachables, continued evolution of disposable sensors, the service of single use systems, a lack of standardization, the challenge to become landfill neutral, the cost and supply chain of consumables, and, ultimately, acceptance by our potential customers.

To balance the risks of this new manufacturing strategy, Catalent consulted with experts and built relationships with the supplier base by seeking supplier partnerships versus simple transactions. Additionally, we are staying active in industry organizations, such as the Bio-Process Systems Alliance, the ASME BioProcessing Equipment group and PDA to help support our infrastructure (e.g., through guidelines and standards), and to enable us to better understand different technologies and trends in the market.

In early 2011, we sold our six stainless steel reactors and made the decision to go with single-use reactors, mixers, and tangential flow filtration skids. This decision was based on aligning our business strategy with our manufacturing capabilities. Implementing single-use systems enabled us to increase the number of runs we could conduct per year.

Ultimately, single-use systems provide us with flexibility and manufacturing scale to support and solve the ongoing challenges that companies will continue to face in biomanufacturing.

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