Transfer, Implementation and Late Stage Development of an End-To-End Single-Use Process for Monoclonal Antibody Manufacture

摘要

Disposable manufacturing platforms are becoming increasingly popular for therapeutic monoclonal antibody (MAb) manufacture, whether as fully disposable platforms or for incorporating single use solutions in to largely fixed (i.e., stainless steel-based, re-usable) manufacturing platforms. While large pharmaceutical companies have largely adopted a platform approach to development and commercialisation of therapeutic monoclonal antibodies, or employ single use solutions for certain unit operations (e.g., seed train expansion), disposable platforms may be more common among small to medium sized, or more recently established, companies. This may have implications for partnerships between small-to-medium and large pharma companies seeking to co-develop and commercialise biopharmaceuticals.