We are looking to manufacture a few different products mammalian and microbial in the same location. We have looked at a few of the flexible facility models for mammalian cell culture. Do you believe that a similar approach using single-use in microbial fermentation and single-use for mammalian would be effective? If so, are there any aspects of planning that you would recommend considering?

Answer

Very definitely…the flexibility imparted to fermentation, like in cell culture, is analogous. If I interpret your question further, might I also say that dual-purpose systems, systems capable of either cell culture or fermentation by switching reactor bags and some accessories are available. This type of dual-purpose product provides another level of flexibility, especially for development and pilot operations. With respect to implementing a flexible manufacturing environment, a comprehensive approach to the owner’s business is recommended, if not required. Single-use technology provide a catalyst for implementing changes necessary to be competitive today and into the future where biologics production is concerned. Single-use technology suppliers, especially for the unit operations become a much deeper “partner” in the business. The more information that can be shared, the better the supplier is able to support business continuity, for things like facility layout/design, operational efficiency, supply chain integration, just-in-time materials delivery and many more. As mentioned in an earlier topic response, footprint, utility requirement and water consumption all change for the better. Personnel skills and training may need augmentation. The technology really provides an excellent opportunity to align a manufacturing entity with specifics of today’s biomolecule while equipping them with ability to handle the changes so often associated with our industry.