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 Future Technologies In Biologics Manufacturing -Transform Bioprocess Productivity And Over Come The Challenges Of Speed, Survival And Innovation
Leveraging Single Use Innovation To Overcome Challenges In Speed, Cost And Maintenance Times Whilst Remaining Flexible For Process & Manufacturing Requirements
Achieving Competitive Advantage And Worldwide Regulatory Compliance In Contract Manufacturing
Road Map into Achieving operational excellence through lean manufacturing
Leveraging Technology With Lean Principles To Overcome Challenges In Speed, Cost Resource, Productivity Whist In Line With Global Regulations, Achieve An Competitive Advantage And Manufacturing Supremacy.
Leveraging Innovation To Transform Bioprocess Productivity: Bridging The Gap Between Upstream Productivity & Down Stream Processes To Over Come Cost, Speed, Regulations & Efficiency Across The Whole Production
Taking a holistic, intergrated approach to disposable manufacturing
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Barbara A. Paldus, Ph.D
CEO
Finesse Solutions
Barb was most recently the CTO of Picarro, a company she founded in 1998. At Picarro, she was responsible for technology strategy, research, and business development, which led to a solid-state Cyan laser product in 2003 and cavity ring-down spectroscopy products in 2004. Barb is currently a partner at Skymoon Ventures. Barb received both her Ph.D. (1998) and M.S.E.E. (1994) degrees in electrical engineering from Stanford University, and her BS (1993) in electrical engineering/applied mathematics from the University of Waterloo. |
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Dr. Arunakumari
Senior Director of Process Development
Medarex
Dr. Arunakumari is Senior Director of Process Development at Medarex, the worldwide developer of human antibody therapeutics. In her role, she oversees the development, scale up and transfer of cell culture and purification processes. Her extensive 16 years experience in management roles at Enzon, Bristol Myers-Squibb, and Medarex, have been instrumental in integrating upstream and downstream processes and achieving 6 g/l in productivity.
She significantly improved over all facility output, batch processing time and cost of goods by developing simple non-protein A purification processes in fewer processing steps and column cycles. Her technique not only optimized conditions to remove all process related contaminants on ion exchange resin comparable to that of affinity chromatography, but also modified the process schemes to require less validation.
These improvements were carried out simultaneous to a pipeline project in process development and managed to scale up ‘ion exchange-processes' to handle up to 5000 liters of cell culture harvest. Alahari's critical contribution to Medarex platform technology produced 14 different humabs between the manufacturing facility and Contract Manufacturing Organizations. |
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Dr. Felix Oehme
Group Leader Biological Development
Bayer HealthCare AG
Head of a biochemical laboratory at Bayer Schering Pharma, Global Biological Development, Wuppertal
Responsibilities:
Development of downstream production processes for clinical manufacturing of protein therapeutics & Project management. |
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Rick Johnston
Co-Director, Biopharmaceutical Operations
University of Berkely
Rick Johnston is the co-director of the University of California's Center for Biopharmaceutical Operations (CBO). The CBO's partners with Industrial and Government organizations to advance the art and practice of biopharmaceutical production operations and logistics. Rick Johnston is a recognized expert on the subject of variability and risk in biological manufacturing. He is also the founder and CEO of Bioproduction Group, a company specializing in advanced decision tools for the biotech industry. |
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Majid Mehtali, PhD
CSO, Vice-President R&D
Vivalis SA, Nantes, France.
Gerhard F. Klement currently serves as CEO & President for Reliance Biopharmaceuticals. Reliance Biopharmaceuticals is part of Reliance Industries, the largest company in India . He is with Reliance since July 2006. The main goal of Reliance is to establish a global Biotechnology company. Within his role he is responsible for the production of recombinant Proteins and MAB, Blood Plasma Products, Vaccines and API'S.
Prior to joining Reliance he served as VP Manufacturing & Technical Operations for ALTUS Pharmaceuticals. Within this role he was leading the manufacturing, process development, formulation and analytical operations for ALTUS .
Mr. Klement served as Chief Technology Officer for the worldwide Biologics and Chemicals Group at Lonza, where he was responsible for new technologies and business development. From 2003 to 2005 Mr. Klement was the Head of Operations, USA and Chief Operating Officer Biopharmaceuticals, Worldwide at Lonza Biologics.
Previously, Mr. Klement held various positions in manufacturing and engineering at Serono and Centocor. Mr. Klement also serves on the Scientific Advisory Board of the New Hampshire Chamber of Commerce and the Scientific Advisory Board of Laureate Pharmaceuticals. He served as well on the board of directors for the New Hampshire . Mr. Klement holds a B.SC. from the University of Agriculture in Vienna , Austria . He received executive training in general management and leadership from IMD and Babson College . |
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