Kolloquium des Center of Life Sciences
Am 20.12.2011 findet ab 15:00 Uhr ein Kolloquium des "Center of Life Sciences" im Neuen Laborgebäude, Seminarraum 1. OG auf dem Campus Bernburg zum Thema "Biotechnology Lifecycle Management – Increasing Process Performance and Robustness by Implementing New Technologies in Existing Processes" statt.
Interessenten sind herzlich eingeladen. (Der Vortrag wird in deutsch gehalten.)
Referent:
Michael Pohlscheidt, PhD, EMBA Intern. SCM
Associate Director Manufacturing Science and Technology
Oceanside Product Operations, Genentech Inc., Oceanside, USA
Genentech ist eine Tochter von Roche in den USA.
The pharmaceutical industry is facing challenges in the upcoming years. Decreasing R&D productivity and increasing development costs combined with increased competition, patent expiries, Biosimilars, etc., put significant pressure on the value and supply chain of global research-driven pharmaceutical companies. Since the 1950s 1222 NMEs have been approved - 1103 small molecules and 119 biologics. The trend towards Biopharmaceuticals products has been seen since the early 80s and recombinant antibodies produced by mammalian cell culture has clearly been the growth driver in the biotech industry creating a meaningful contribution to patients’ lives. However, the trend of NBE is stagnant/ declining while the costs are increasing substantially in a strictly regulated environment1. In order to answer these threats the industry has launched several initiatives along the value and supply chain focusing on several areas, e.g.: Enhance success rate in R&D, increase speed to market, excellence in supply chain management, Operational Excellence (six sigma and lean), business process management, technology lifecycle management, etc2.
For operations the major focus during the life cycle of a process is to guarantee uninterrupted supply of high quality products in compliance with regulatory expectations at best financial performance for a changing evolving product portfolio. Manufacturing binds the majority of assets in a company and therefore efficiency in operations is key to free up resources to invest in R&D. New technologies and their holistic management are crucial to the success and driving efficiencies in operations. Due to extensive process development work several new technologies have made their way into biotech manufacturing with new portfolio projects. Examples include disposable technologies, supply chain risk mitigation measures, and high temperature short time media treatment. In order to derive the full benefits of these mature technologies for existing manufacturing processes, supply chain risk mitigation and end to end technology lifecycle management is necessary. Driving incremental innovation in existing processes by applying well known and mature technologies is achievable and in alignment with the regulatory expectations given having an appropriate regulatory and quality strategy in place.
This presentation will briefly introduce Roche as a company. After the company introduction the presentation will provide some background to a technology lifecycle management model and case studies of applying mature technologies to existing processes highlighting business considerations, regulatory aspects and product quality aspects.
1 B. Munos, “Lessons learned from 60 years of pharmaceutical Innovation”, Nature Reviews, Drug Discovery, Vol 8, p 959 – 968, December 2009
2 M. Pohlscheidt, L. Sanders, S. Marrer, M. Gemuend, R. Franklin, H. Tschirky., “Strategic Technology-, Network and Innovation Management - Securing the Supply Chain of Tomorrow“, EMBA Thesis, ETH Zurich, 2010
