Speakers (26)
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Edgar Sur
Director of Operational Excellence, Product Supply Biotech/Product Supply NA,
Bayer Healthcare
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Dr Divakar Ramakrishnan
General Manager operations Kinsale
Eli Lilly & Company
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Divakar Ramakrishnan, Ph.D., presently serves as General Manager of Eli Lilly S.A – Irish Operations, where he has leadership responsibilities for a multi-mission commercialization & manufacturing operations site spanning biotech & chemical process technologies. By way of educational background, Divakar has a Ph.D. in Chemical Engineering from Pennsylvania State University, an MBA from Harvard Business School, and a B. Tech in Chemi ...more
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Dr Wolfgang Berthold
Chief Technology Officer
Biogen Idec
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Dr. Markus Schneider
Technology Director
Novartis Pharma
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Marc Bastiaansen
Senior Staff Scientist
Schering Plough
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Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day& ...more
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Klaus Kohler
Industry Manager Life Sciences
Endress+Hauser
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Shorter times to market, fast-track-projects and shorter plant life-cycles are getting a bigger challenge in the Life Science industry. This workshop demonstrates how a qualified industry specialist and instrumentation/automation one-stop-shop can help reduce time to production and increase plant efficiency and quality at the same time. New technologies for instrumentation and process analytics support faster qualification in a regulated environ ...more
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Dr. Stefan Schlatter
Associate Director Cell Culture Technology
Boehringer Ingelheim
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Dr. Gunter Jagschies
Senior Director Strategic Customer Relations
GE Healthcare Life Sciences
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A step-by-step review of a typical Mab platform process from inoculation to final filtration will provide solutions for single- or campaign-use technology as well as technical and economical criteria to decide what the best alternative would be: a classic equipment setup or the disposable option.
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Dr. Justin Neway
Executive Vice President and Chief Science Officer
Aegis Analytical Corporation
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The FDA now defines process validation as "the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products." On-going process validation is therefore the most important practical outcome of any QbD prorgam.
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Dr. Amit Mehta
Snr. Engineer/Group Leader Late Stage Purification
Genentech
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Michael Schousboe
Principal Scientist, Expert Manufacturing Science and Quality, Member of the ASTM E55 Committee on PAT
Novo Nordisk
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The session will illustrate how Novo Nordisk is approaching the implementation of Quality by Design. The implementation is focussing on pragmatic and effective change management where good examples are used to pave the road for changing the mindset in development of products and processes. The changing of mindset takes time, and requires buy in at all levels. The implementation realised from the beginning that old and new concepts had to be worki ...more
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Dr. Barbara A. Paldus
CEO
Finesse Solutions, LLC
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As cell culture titers continue to increase, more processes will leverage the benefits of single-use bioreactors. In order to accelerate the adoption process of single-use upstream systems, from labscale to production, bioreactor systems need to take one final step of evolution, however. We will present the newly launched “Generation 3” single-use measurement and automation systems, which have fully integrated single-use sensors (t ...more
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Prof. Dr. Christian Frech
University of Applied Sciences
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Therapeutic proteins make up an increasing proportion of new drugs. Their production requires robust and rapid processes with high purity and yield. Recovery and purification operations are the most time-consuming and the development of the individual purification strategy is complex. Ion exchange chromatography (IEC) plays a crucial role in almost all protein purification processes. IEC results in high purities combined with high recoveries and ...more
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Jon Reid
Director of Strategic Market Development
Thermo Fisher Scientific
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Single-use bioreactors are becoming accepted for cGMP bioproduction and are also resulting in a change of approach to that used with conventional systems. This presentation looks at the design of available systems of the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) concentrating on the mixing, sparging, monitoring, control and sampling options. Modes of use and process operating parameters are shown with examples of the range of ...more
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Huw Hughes
Head of Development
Pfizer
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Terts Ashibi
Site OE Lead
Medimmune UK Ltd.
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Vikas Gupta
Group Product Manager Process Systems
Millipore Corporation
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While single-use assemblies have demonstrated performance benefits including lower risk of contamination, reduced cleaning and validation requirements, and increased flexibility, questions exist about the environmental sustainability of disposable technologies. End-of-life management is of particular concern since the solid waste generated at end-of-life is often perceived as being a major contributor to the total life cycle environmental burden ...more
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Stefan Egli
Vice President Marketing Europe & Asia
Pall Life Sciences
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Dr. Aziz Cayli
Chief Executive Officer
Cellca GmbH
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An expression platform was developed comprising a CHO cell line for easy manufacturing. The cell line grows rapidly in all scales, doesn’t produce the typical metabolic waste products and thus represents a paradigm change. The expression platform was tested with antibodies as well as with non-antibodies and product concentrations up to 7 g/l have been achieved in fed-batch processes. The scalability has been demonstrated at 2500 l scale. Th ...more
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Dr Christian Grote-Westrick
Director of Recombinant Protein Production
imusyn GmbH & Co. KG
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Providing multi-product capabilities enables parallel production of biological agents and reveals high requirements to project management strategies. Broadband production lines can be consolidated by robust platform concepts. The way to a successful platform crosses challenges in optimising a mixture of plant design, innovation, lean management, regulatory affairs, analytical toolboxes and disposable technologies. Long-life cycles of product line ...more
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Frank Kohne
Group Leader DSP Development
Rentschler Biotechnologie
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Frank Kohne is head of DSP Development at Rentschler Biotechnologie in Laupheim, Germany, which he joined in 2003. The main task of the group comprises all aspects of downstream development in animal cell culture-based processes for therapeutic protein production including process transfer to GMP manufacturing and formulation development as well as all the respective demanding services for client- and partner-driven processes. Before joining Rent ...more
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laura chirica
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Villaume Kal
Vice-President
DSM BioSolutions
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The largest paradox in development of novel biopharmaceuticals is that in early clinical stages there is a continuous pressure to keep process development time and costs minimal (as risk of failure in the clinic is still very high), while in later clinical stages process robustness, scalability and economics become important factors for eventual commercial success. However, only minor process changes are allowed in this clinical development traje ...more
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Dr. Ing-Marie , Olsson
Application Specialist
Umetrics AB
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To achieve successful implementation of Qbd/ PAT solutions in biopharmaceutical industries a strong and long term commitment from the company is necessary. A team of dedicated experts from various fields is essential, both from within and outside the company, to cover all pieces required to reach the goal. In this talk one piece of the puzzle will be considered, the multivariate online monitoring systems. A typical route to implementation, from s ...more
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Dr Michael Li
Manager of Process Sciences
Asahi Kasei Bioprocess
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Michael Li received a Doctoral Degree in Chemistry from the University of Hawaii. His past work experience include analytical methods development of protein and peptide therapeutics, and custom-made chromatography resins to separate closely related protein and peptide species. In the past, Dr. Li taught “Analysis of Protein and Peptide by HPLC” for American Chemical Society and a webinar “Applying PAT-based technology to Liquid ...more
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