(586ae) Disposable Bags in Biopharmaceutical: Approaches to Storing Difficult Solutions

Arroyo, A., Genentech, Inc.

Disposable bags have emerged as an attractive alternative to traditional stainless steel and glass containers used in biomanufacturing because they offer potential technical and economic advantages, as well as flexibility in operations. However, as these disposable bags are used in an increasing number of applications, previously identified risks are becoming a reality that must be managed and new challenges are arising. Bags that are acceptable for aqueous buffers in an upstream step are not necessarily acceptable for other process streams, especially if the step is closer to the final product.  The purpose of this presentation is to discuss the storage of “difficult” solutions, like surfactants, in bioprocess bags for product contact applications during the manufacture of clinical or commercial biologics. The discussion will include a case study of storage of diluted Polysorbate buffer, highlighting the challenges, evaluation process, and selection of an appropriate bag for the application. Key elements of the project that will be discussed in detail are (1) qualification of the bag film and (2) assessment of process compatibility.