The increase in adoption of single-use bioprocess technology for manufacturing biopharmaceuticals has been driven by the many advantages it offers, such as increased flexibility. However, the materials of construction can be more complex than conventional stainless steel vessels. Single-use containers are constructed from plastic films, which are often composed of several layers of polymers with additives for processing and performance.

The diversity of applications for single-use containers requires film that can achieve a wide variety of performance attributes such as mechanical strength, flexibility, biocompatibility, and suitable gas barrier properties to name but a few. The right balance of chemical composition and film architecture is critical for achieving desired performance across many applications. Also, in light of industry reports of a leachate, originating from bioprocess containers, that can negatively impact cell culture growth with certain sensitive cell lines, it has become imperative to understand the profile of extractable compounds resulting from the film chemistry. Over the past several years, GE Healthcare has worked closely with biopharmaceutical manufacturers to understand their applications and resulting requirements for bioprocess film performance. This investment in learning has led to the establishment of a scientifically driven film development process focused on the innovation of bioprocess films that are fit for purpose. The process is built on a strong foundation of knowledge in science, engineering, and bioprocess applications and incorporates key learnings about extractables and  leachables, as well as considerations for security of supply via supply chain management.