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Repligen Virtual Technical Seminar

Overcome bioprocessing capacity challenges

tuesday, July 13, 2021

11:00 AM EDT  | 8:00 AM PDT | 3 PM GMT

 

In these unprecedented times, led by the global war against the COVID pandemic, Bioprocessing manufacturers are experiencing surge in demand for solutions that enhance process economics and process optimizations. This virtual seminar reviews the primary drivers of change, learnings from early adopters of transformative technologies, evaluations of risk landscapes and collaborations to help set the standards for modern bioprocessing.

Led by plenary speaker Prof. J. Christopher Love, topics will include the vision for near- and long-term manufacturing processes, and workflow solutions for harvest clarification, downstream purification, UF/DF filtration and analytics.

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摘要

The recent pandemic provides context for the global need to increase manufacturing readiness of biopharmaceuticals and vaccines. New strategies towards continuous and distributed manufacturing will be required to meet the envisioned benefits of new therapies on a global scale with equity. Proof of concept for systems that could achieve capacity and speed and quality and configurability together will be discussed. 

演讲人简历

love-2019-copy.jpgJ. Christopher Love是Raymond A.(1921)和Helen E. St. Laurent化学工程教授,也是麻省理工学院科赫综合癌症研究所的成员。此外,他还是Eli和Edythe L. Broad研究所以及MGH Ragon研究所、MIT和哈佛的准成员。Love教授于2004年获得哈佛大学物理化学博士学位。他于2004年-2005年在哈佛医学院及2005年-2007年在免疫疾病研究所将其研究扩展到了免疫学领域。他的研究集中在使用简单的微系统来监测慢性人类疾病临床样本中的细胞,以及开发新方法,用于生产高效且负担得起的生物药和疫苗。Love教授在2009年被评为Dana人类免疫学学者,并被授予Keck杰出青年医学研究学者,在2010年被评为科普杰出人才10之一,并被Camille Dreyfus授予教师奖学金。在麻省理工学院,他是替代宿主协会主席,其是麻省理工学院与工业界独特的合作,致力于推动生物制药和疫苗的新生产宿主的发展。他之前曾在Biogen(2015-2016)担任驻地杰出工程师,还为多家生物技术和生物制药公司提供咨询服务,包括三家基于他在麻省理工学院实验室所开发的技术的初创公司(Honeycomb、OneCyte和Sunflower)。

 

演讲人简历

jim_bylund.pngJames R. Bylund joined Repligen in March of 2020 as Senior Vice President, Global Operations and IT, overseeing all operations and IT functions on a global basis. Prior to joining Repligen, Mr. Bylund spent ten years at Thermo Fisher Scientific in a number of roles including Vice President and General Manager of the Single Use Technologies Business Unit and Vice President of Global Operations for the Bioproduction Division. Prior to joining Thermo Fisher, Mr. Bylund also worked for Fiserv (9 years) and Eli Lilly and Company (7 years) in a variety of leadership roles. He has significant experience in managing multiple operating sites across the globe and scaling operations to meet rapidly growing demand. Mr. Bylund is a passionate proponent of continuous improvement and has consistently demonstrated the ability to assemble and grow highly effective teams. He holds a B.S in Accounting from Utah State University and an M.B.A. from Indiana University.

 

摘要

Gene therapy has now gone beyond proof of concept and entered mainstream healthcare. The success of gene therapy requires work on manufacturing processes to ensure these therapies are widely available. Regulatory authorities are tasked with assuring quality, efficacy, and safety of the final product- and placing increasing scrutiny on the manufacturing process. In this talk, we will discuss the pain points associated with lentivirus and AAV viral vector production and purification process at various manufacturing scales. We present two case studies illustrating the next generation manufacturing process for viral vector intensification using HEK293 cells in suspension. These studies demonstrate how to enhance viral vector overall process yield by integrating the advanced technology solutions for the entire lentivirus and AAV production process using suspension cell culture and implementation of advanced intensification bioprocess strategies for growth, harvest, and purification.

演讲人简历

leggman.jpgRachel has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vectors and proteins for gene therapy and biologics. She completed her Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Repligen in 2021 as a subject matter expert offering technical assistance to help customers achieve their technical and operational objectives in their manufacturing of virus-based therapeutics with a focus on gene therapy processes including upstream, downstream, analytics and scalability. In addition to supporting global customers and building high level networks, Rachel is supporting various internal cross-functional activities and external collaborations. Prior to joining Repligen, Rachel held several scientific and leadership roles at Microbiology & Molecular Genetics department at Harvard Medical School, CRO SBH Sciences, Seahorse Biosciences part of Agilent, CDMO Goodwin Biotechnology and Pall Corp part of Danaher.

摘要

Increasing VCD with cell retention throughout the seed train delivers more product in less time and compresses overall timelines from vial to harvest.  Through application development, the XCell™ Technology can be utilized in both fed-batch and perfusion modes. Case studies describing a 2-8X N bioreactor output increase, a 10X product cost reduction and a 30% facility output will be discussed.

演讲人简历

CHillVirtualSeminarImageJUL2021.jpgCharles Hill is a motivated engineer in the biopharmaceutical industry with a background in Biomedical Engineering from Worcester Polytechnic Institute in Worcester, MA. Charles has been in the biotech industry for over 4 years, and most recently at Repligen Corporation, helping companies successfully implement the XCell ATF® and KrosFlo® TFDF® technologies. Charles previously worked at Bristol-Myers Squibb performing different functions in process development, characterization, and technical transfer for perfusion processes. Charles is currently the Upstream Field Applications Scientist at Repligen for the Northeast Region of North America.

摘要

Single-use flow paths connect core technologies to process execution. Development of detailed engineering drawings, diverse process requirements, many potential single-use components and complex sourcing logistics together create manufacturing challenges that impede the biopharmaceutical supply chain. Significant advancements have been made by coordinating: technical consultation, an on-line configurator, key supply agreements and integration of the flow path with core technologies. The result accelerates and simplifies manufacturing process from while maintaining the configurability required to accommodate diverse process requirements of the bioprocess community.  

演讲人简历

DanielSpurginVirtualSeminarImageJUL2021.jpgDaniel Spurgin holds a B.S. from Santa Clara University and a Master of Business and Science for the Keck Graduate Institute for Applied Life Sciences at the Claremont Colleges.  He has 15 years of life sciences industry experience and has worked in management consulting, startups, and large corporations.  Prior to joining Repligen as a Product Manager, he was both a Product Manager and a Marketing Manager at Phenomenex, a Danaher company focused on chromatography and separation sciences. 

 

There is no charge for attendance but registration is required for this virtual event. Seats are limited to end-users of bioprocessing tools and technologies.

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