2013 Archived Content
August 21-22, 2013
Cambridge Healthtech Institute’s 3rd Annual
Scaling Up & Down with Optimized Bioreactors + Disposables
Making It Work
Day 1 | Day 2 | Short Courses | Download Brochure
Thursday, August 22
8:00 am Morning Coffee
8:25 Chairperson’s Remarks
Ken M. Wong, Senior Scientist, Specialty Analytical, Center for Extractables and Leachables, Merck & Co., Inc.
8:30 A Novel Seed Train Process Using High Density (HD) Cell Banking, Disposable Wave Bioreactor and Alternating Tangential Flow (ATF) Perfusion Technologies
Benjamin Wright, Process Engineer, Genzyme Corporation, a Sanofi Company - Biography
9:00 Scale-Up of a Fed-Batch Process in a Single-Use Bioreactor for the Expression of Monovalent Hemagglutinins, Components of the Flublok Vaccine
Nikolai Khramtsov, Ph.D., Associate Director, Upstream Development, Product Realization Department, Protein Sciences Corporation
We developed a fed-batch process for increasing the productivity of rHA in 2L glass bioreactors, and scaled the process first to 10L in stainless steel units, and later to 200L in single-use bioreactors (SUB). We observed a twofold increase in rHA productivity by the fed-batch process compared to the batch process. We will present data on cell growth, pH, and accumulation of metabolites during the cell growth and protein production phase, and expression profiles obtained in batch and fed-batch processes at 2, 10 and 200L scales.
9:30 Predictable Process Optimization with a Scale-Down System for Large Scale Bioreactors - from 5 ml to 2500 Liter in Disposable Bioreactors
Maria J. De Jesus, Ph.D., COO & Vice President, Process Sciences, ExcellGene SA - Biography
Mammalian suspension cells achieved highest volumetric yields in fully controlled stirred bioreactors, but failed in “scale-down” in the past. Most simple scale-down systems do not provide enough oxygen and also result in insufficient CO2 stripping, for example spinners or shake flasks. Orbital shaking of cylindrical vessels, initially executed with 50 ml “TubeSpin bioreactors,” has now been scaled to 2500 L. The talk shows that profound understanding of engineering and biology provides un-used opportunities in manufacturing.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:45 Characterization of Mixing Efficiency to Ensure Process Equivalence
Ludovic Peeters, Scientist, New Product Development, GSK Vaccines - Biography
GlaxoSmithKline Vaccines’s cell culture department selected and implemented a Single-Use Bioreactor technology in their process development facilities. One important technology selection criteria was the design equivalence between stainless steel and single-use bioreactors. But are the mixing conditions in the single-use bioreactors really equivalent to stainless steel? This presentation will try to answer this question by comparing results from detailed mixing characterization of both technologies.
11:15 Single-Use Scaling Considerations for Optimizing Bioreactor Performance
Mark McElligott, Partner and Principal Process Engineer, Process Design Solutions - Biography
Scaling optimization considerations from a technical, quality and supply-chain perspective will be discussed utilizing case study material. Being prepared with the tools to buy down risk for scaling cell culture processes will save time through removing delays that are not commonly experienced with traditional SS systems. Strategies for control over the degree of flexibility will be covered, including success through effective collaboration between the SU vendor and the end-user, as well as, with an effectively written TQA to support SU product development.
11:45 Disposable Bioprocess Technologies used in Early Development of Sandoz Biosimilars
Matjaž Tisu, Senior Scientist, Sandoz Biopharmaceuticals - Biography
Due to its benefits, the disposable bioprocess technology has been recognized as a future alternative to the established traditional reusable technology for development and production of biopharmaceuticals. Strategy, rationale and approach for implementation of small scale disposable bioreactors in early development of biosimilars will be presented. Testing and qualification of disposable systems from different suppliers, including a high-throughput micro-bioreactor system will be shown. The presentation will also include case studies on different proteins (mAb, fusion proteins…) demonstrating comparable performance and product quality in single use bioreactors.
12:15 pm Luncheon Presentation: Application of Single Use Bioreactors for Culturing Adherent MDCK Cells for Virus Production
Michael McGlothlen, Manager, Upstream Process Innovation Center, EMD Millipore
The Mobius® CellReady bioreactor product platform incorporates novel disposable technologies that provide optimal performance for suspension mammalian cell culture. Here we show the utility of EMD Millipore’s 3L and 50L Mobius® CellReady single use bioreactors for the cultivation of adherent mammalian cells on microcarriers. Cytodex3® and Solohill® collagen microcarriers were first tested in a mixing study to assess feasibility. We evaluated the normalized mixing speed required in the 3L and 50L to achieve a suspension of the microcarriers and enable growth of the cells.
1:00 End of Conference
Day 1 | Day 2 | Short Courses | Download Brochure