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

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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



There has been a rising demand for biologic compounds in recent years, but biomanufacturing processes have met this challenge through technology, innovation, and hard work. Many of the changes that have taken place in biomanufacturing have been step changes. For example, as biomanufacturing has shifted from unmodified organisms, such as plants and pigs, to recombinant cells grown in bioreactors, expression levels have increased from milligrams per liter to grams per liter. This expression increase, however, has resulted in many facilities having mismatched upstream and downstream capacities. Companies that implemented new manufacturing strategies to adjust and adapt to changing processes have been able to provide reliably sourced products, while those companies that miscalculated demands and capacities have become acquisition targets.

By the end of 2010, Catalent had grown out of its current manufacturing facility. After identifying a new location, the company began to evaluate single-use systems, which have received growing acceptance in the biopharmaceutical manufacturing industry because of the associated lower facility and equipment costs, as well as the reduced effort in suite turnovers. Catalent had recently purchased six new stainless-steel reactors and also had experience with this technology. However, after consulting with experts, the ultimate choice was made to sell the stainless-steel reactors and to go with single-use reactors, mixers, and tangential flow filtration skids. To aid successful implementation, the company built relationships with the supplier base by seeking supplier partnerships versus simple transactions. The decision was based on aligning business strategy with manufacturing capabilities. Implementing single-use systems enabled the company to increase the number of runs it could conduct per year.

Case study
The emergence of single-use technologies is one of the key changes that has impacted biopharmaceutical manufacturing. In 2010, Catalent faced the decision as to whether to adopt single-use technologies or to continue with traditional stainless-steel operations.

In 2001, we transitioned from a bovine transgenic company to instead focus on mammalian cell line engineering and manufacturing. Our GPEx mammalian expression technology provides short timelines and stable production of biopharmaceutical proteins, and can provide a master cell bank candidate in around 4.5 months. To help launch the technology, we built our first cGMP facility, which comprised two 100L noncGMP stainless steel reactors and two 200 L cGMP bioreactor trains. As the technology became more well established and utilized within the biopharmaceutical industry, we sought to expand the cGMP space. In 2008, we purchased six new stainless‑steel reactors (two 100 L bioreactors, and 200 L, 500 L, 1000 L, and 2500 L bioreactors). With the economic conditions deteriorating at the time, however, our expansion strategy was postponed. The economic downturn changed the dynamics of the market and venture capital markets slowed, but our expression technology was in high demand because of the time savings it offered in bringing new products to the clinic; particularly for small- to mid-sized biologics companies who were carefully monitoring their cash flows. By the end of 2010, we were nearing full capacity so we revisited our expansion plans.


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