023b - Start with the end in mind. How to facilitate transfer from non-GMP to GMP

June 28, 2018

In this podcast, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from a non-GMP to a GMP environment, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless.

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023 - Start with the end in mind. How to facilitate transfer from non-GMP to GMP

June 26, 2018

In this podcast, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from a non-GMP to a GMP environment, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless..

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022 - Modeling Downstream Disruptive Technologies to Improve Downstream bioprocessing.

June 8, 2018

In this podcast, we interviewed Dr. Yuyi Shen about the benefits of modeling disruptive technologies to improve downstream bioprocessing and evaluating the financial impact of implementing these technologies..

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021 - Successful Mesenchymal Stem Cell Manufacturing for Cell Therapy Applications

May 30, 2018

In this podcast, we interviewed Dr. Ross Macdonald about the use of mesenchymal stem cells for cell therapy applications and key criteria for successful manufacturing. 

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020 - Bioprocessing Technologies for Stem Cell Therapy

April 7, 2018

In this podcast, we interviewed Ricardo Baptista, Lead Process Development Scientist, Cell and Gene Therapy Catapult, UK, about his impressions on current bioprocessing technologies for stem cell therapy manufacturing and possible future innovations.

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019 - Cell Therapy Manufacturing - Opportunities and Challenges

March 17, 2018

In this podcast, we interviewed Dr. Robert Preti about the past, present, and future of global cell therapy manufacturing. We also discussed major industry milestones, manufacturing challenges, and opportunities for the further improvements.

Robert A. Preti, PhD
Chief Executive Officer and President, Hitachi Chemical Advanced Therapeutics Solutions, LLC
General Manager, Regenerative Medicine Business Sector, Hitachi Chemical Co. Ltd.

Dr. Robert “Bob” Preti is the co-founder and the visionary behind the successful growth and development strategy of PCT (on October 2, 2017 renamed Hitachi Chemical Advanced Therapeutics Solutions, LLC or “HCATS”) over much of the last two decades. Upon PCT’s acquisition by Hitachi Chemical Co., Ltd. in May 2017, Bob’s role expanded to General Manager, Regenerative Medicine Business Sector of Hitachi Chemical, responsible for development, management and oversight of the global business operations of Hitachi Chemical’s regenerative medicine business unit.  Bob built HCATS to meet a recognized need for high quality manufacturing and development services in an emerging industry. Bob is currently Chairman for the Alliance for Regenerative Medicine, where, among other activities, he previously served as Vice Chairman and in other roles. Bob holds a BS degree in biology from Fordham University, and a MS degree and Doctorate, both in biology, from New York University.

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018 - Continuous Biomanufacturing Implementation now and in the future

March 6, 2018
In this podcast, we interviewed Dr. Peter Levison, Senior Marketing Director – Downstream Processing, Pall Life Sciences about the evolution and benefits of continuous biomanufacturing, what implementation looks like today and what still needs to be realized for full industry adoption.
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017 - Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity on Cell Culture Dish.

February 1, 2018

In this podcast and accompanying article, we interviewed Silke Bergheim-Pietza, Global Product Manager Depth Filtration, Pall. We discussed challenges faced in the cell harvesting step, in particular, selecting the best cell harvesting method based on the cell density and feed turbidity of the process and meeting the demand of increasing cell densities. Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies.

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016 - Addressing Challenges in Downstream Biomanufacturing with a platform purification approach

January 30, 2018

In this podcast, we interviewed Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the biggest challenges in Downstream biomanufacturing including overcoming bottlenecks, changing antibody structures and bioburden control. Jonathan shared how a purification platform can address some of these issues and discusses purification challenges that still need to be resolved.

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015 - Novel technology enables encapsulated cell therapies without triggering fibrosis

December 12, 2017

In this podcast, we interviewed Dr. Paul Wotton, CEO, about Sigilon Therapeutics’ discovery platform. The platform combines cell engineering and biocompatible Afibromer technology to enable cell therapies that do not trigger fibrosis

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