Flexible Biomanufacturing Processes that Address the Needs of the Future.
: As the age of the blockbuster drug recedes, the business model for the biopharmaceutical industry is evolving at an ever-increasing pace. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear: the traditional manufacturing strategy of constructing large-scale, purpose-built, capital-intensive facilities will no longer meet the industry's emerging production and economic requirements. Therefore, the authors of this chapter describe the new approach for designing and implementing flexible production processes for monoclonal antibodies and focus on the points to consider as well as the lessons learned from past experience in engineering such systems. A conceptual integrated design is presented that can be used as a blueprint for next-generation biomanufacturing facilities. In addition, this chapter discusses the benefits of the new approach with respect to flexibility, cost, and schedule. The concept presented here can be applied to other biopharmaceutical manufacturing processes and facilities, including-but not limited to-vaccine manufacturing, multiproduct and/or multiprocess capability, clinical manufacturing, and so on.
Sartorius Stedim Biotech GmbH, Göttingen, Germany.
Bernhard
B
Diel
Christian
C
Manzke
Thorsten
T
Peuker
D000911:Antibodies, Monoclonal / Q000096:biosynthesis; D059451:Biosimilar Pharmaceuticals; D004345:Drug Industry; D005544:Forecasting; D006801:Humans; D008962:Models, Theoretical; D014612:Vaccines
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D014612:Vaccines