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A glimpse into the future of mammalian cell culture process development: innovative approaches to impact time to clinic, product quality, and cost of process development and commercial manufacturing
MONDAY 14 JULY BIOCHEMICAL ENGINEERING JOURNAL YOUNG INVESTIGATOR AWARD LECTURE
Monday 14 July Biochemical Engineering Journal Investigator Award Lecture
Young
YI – 1 A glimpse into the future of mammalian cell culture process development: innovative approaches to impact time to clinic, product quality, and cost of process development and commercial manufacturing Chetan Goudar Amgen Inc., United States
There has been remarkable progress in cell line generation and cell culture processes over the past 2 decades. Expression levels have increased by orders of magnitude and a broad spectrum of complex biotherapeutics have been successfully manufactured at commercial scale. Despite these advances, it is important to recognize that the future poses fundamentally different challenges. While development costs and speed to in vivo validation of biology will face increasing pressure, decentralized manufacturing is increasingly becoming a necessity for global reach of a
S10
www.elsevier.com/locate/nbt
New Biotechnology · Volume 31S · July 2014
biotherapeutic, both from regulatory and economic standpoints, which has implications for commercial manufacturing. Increased regulatory clarity around biosimilars has intensified efforts in this space and matching product quality of molecules developed decades ago with current processes is most effectively done with robust mechanistic understanding of cellular processes rather than by purely empirical approaches. In this changing landscape, recent advances in systems biology and a renewed interest in continuous perfusion cultivation offer avenues to bring about paradigm shifts in cell culture process development and commercial manufacturing. An approach for streamlined cell line and early-stage cell culture process development will be presented which can accelerate time to human clinical testing by as much as 8 months. Application of a poly-omics systems biology approach for identifying modulators for a critical product quality attribute will be presented followed by validation of these targets using cell line engineering. Recent dramatic productivity enhancements from continuous perfusion cultures will be presented and the implications of these advances on next-generation commercial manufacturing facilities will be discussed. http://dx.doi.org/10.1016/j.nbt.2014.05.1634
Monday 14 July Biochemical Engineering Journal Investigator Award Lecture
Young
YI – 1 A glimpse into the future of mammalian cell culture process development: innovative approaches to impact time to clinic, product quality, and cost of process development and commercial manufacturing Chetan Goudar Amgen Inc., United States
There has been remarkable progress in cell line generation and cell culture processes over the past 2 decades. Expression levels have increased by orders of magnitude and a broad spectrum of complex biotherapeutics have been successfully manufactured at commercial scale. Despite these advances, it is important to recognize that the future poses fundamentally different challenges. While development costs and speed to in vivo validation of biology will face increasing pressure, decentralized manufacturing is increasingly becoming a necessity for global reach of a
S10
www.elsevier.com/locate/nbt
New Biotechnology · Volume 31S · July 2014
biotherapeutic, both from regulatory and economic standpoints, which has implications for commercial manufacturing. Increased regulatory clarity around biosimilars has intensified efforts in this space and matching product quality of molecules developed decades ago with current processes is most effectively done with robust mechanistic understanding of cellular processes rather than by purely empirical approaches. In this changing landscape, recent advances in systems biology and a renewed interest in continuous perfusion cultivation offer avenues to bring about paradigm shifts in cell culture process development and commercial manufacturing. An approach for streamlined cell line and early-stage cell culture process development will be presented which can accelerate time to human clinical testing by as much as 8 months. Application of a poly-omics systems biology approach for identifying modulators for a critical product quality attribute will be presented followed by validation of these targets using cell line engineering. Recent dramatic productivity enhancements from continuous perfusion cultures will be presented and the implications of these advances on next-generation commercial manufacturing facilities will be discussed. http://dx.doi.org/10.1016/j.nbt.2014.05.1634