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Seminar on Protein Separation In Biopharmaceutical Manufacturing


Mark your calendars for our next Complya Seminar Series featuring

特邀您预留时间参加本次智真生物系列特色研讨会

“Protein Separations in Downstream Processing for Biopharmaceutical Manufacturing”

Join us on Thursday, October 19, at the Holiday Inn Pudong to hear international experts answer your questions on protein separations in downstream processing for biopharmaceutical manufacturing.  This seminar is packed with information you can use in developing downstream processes for biopharmaceuticals. In this seminar you will also learn about a new cost-effective protein A chromatography resin.

欢迎参加10月19日星期四,在上海浦东假日酒店举办的研讨会,会有国际专家讲解关于生物医药生产中下游工艺的蛋白质纯化问题。

 

Presentations and Speakers are described below.  This is an important seminar for all process development, manufacturing, Quality Assurance, and Quality Control specialists in the biopharmaceutical industry.


Sign up now for these FREE outstanding presentations brought to you by Complya Asia.  A delicious buffet lunch is included for all participants. Seating is limited so register early.  Register at http://jsrlife.eventdove.com/ or send email to Juan (juan.shao@complya-asia.com).  Watch for additional details and tell your friends.

欢迎立即报名参加由智真生物筹备的免费研讨会。会议将为每位参会者提供午餐。名额有限,欢迎尽快报名。报名地址http://jsrlife.eventdove.com/或发送邮件给邵娟(juan.shao@complya-asia.com)。请耐心等候更多信息并转告您的朋友和同事。

 

Seminar presentations include:

·         Introduction to JSR Life Sciences

·         How to Construct a Protein A Affinity Resin Life Cycle Study to meet regulatory, manufacturing and supply chain requirements

·         A Case Study: Comparison of Protein A Chromatographic Stationary Phases for Monoclonal Antibody Purification

·         Practical Protocol and Advice for Packing of Amsphere™ A3 resin

·         A Chinese CDMO Perspective: Selecting a Protein A Resin for Commercial Drug Manufacturing

  

会议地址: 上海浦东假日酒店(上海市浦东新区东方路899

会议时间: 2017年10月19日 8:45 ~ 13:00 


Speakers:

Marty Siwak

Chief Technology Officer, JSR Life Sciences

Marty Siwak is currently Chief Technology Officer at JSR Life Sciences in Sunnyvale, CA with more than 38 years of experience in the life sciences industry. He is part of a global team responsible for technology development for biopharmaceutical drug purification.  Mr. Siwak has developed and commercialized numerous separations and protein purification technologies over his career. He holds multiple patents and publications on biopharmaceutical purification and virus clearance technologies. He has degrees in both Chemical Engineering and Biochemistry from the University of Connecticut.

 

Masa Nagaya

SeniorGlobal Manager of the Separation Science Group (SSG)

JSR Life Sciences in Sunnyvale, California.

Mr. Nagaya has over ten years experience in CMC operations for bulk drug substance and drug products, product management of membrane and chromatography resin technologies, and process engineering of advanced semiconductor nanolithography materials. Today he leads JSR’s global SSG team in process and applications development of purification and recovery technologies for the global biopharmaceutical industry.He received a BS in Chemical Engineering from Bucknell University.


Takashi Matsuda PhD

R&D Manager, Senior Researcher, JSR Life Sciences Corporation, Tsukuba, Japan

Takashi Matsuda, after completing his PhD in physical chemistry of colloids and interfaces at Kyushu University of Japan in 2007, joined JSR Corporation to work on chemical mechanical planarization materials development for semiconductor manufacturing processes. From 2012, he stayed at Erlangen-Nuremberg University of Germany as a guest researcher for the study of functionalized ionic liquids synthesis and its catalytic surface reaction for fuel cell material research.He moved to JSR Life Sciences Corporation in 2014 and is currently responsible for leading chromatography resin development in the separation sciences group ofJSR life Sciences Corporation as R&D manager.

 

Peter Shen 

Vice President of Process Development and Clinical Manufacturing

WuXi Biologics

Peter Shen is currently a Vice President of Process Development and Manufacturing at Wuxi Biologics in Shanghai.  He has more than 30 years of experiences in the life sciences industry, primarily in downstream process development.  His areas of focus include purification and scale-up and GMP/Clinical manufacturing.  He has worked at several US-based, global pharmaceutical companies including Gallus, Johnson & Johnson and Bristol-Myers Squibb.  He has degrees from China Pharmaceutical University and New Mexico State University.


Abstracts

Introduction to JSR Life Sciences

A brief welcome and introduction to the JSR Life Sciences Bioprocess organization will be presented. We will review our background and how the JSR Life Sciencebusiness has evolved.  We will also look at our sister companies, contract development and manufacturing organization (CDMO) KBI Biopharma, Inc., and cell-line development company, Selexis SA. Our current business structure and strategy, as well as our capabilities and future technology portfolio, will also be presented.

 

How To Construct a Protein A Affinity Resin Life Cycle Study to Meet Regulatory, Manufacturing and Supply Chain Requirements

The assessment of Protein A resin life time is a key element in developing a commercial manufacturing process particularly regarding the impact of the cleaning and regeneration steps as they relate to purity and yield.  In addition, understanding resin lifetime is essential to optimizeMab product quality attributes as well as manufacturing operations and to support supply chain economics. Life cycle studies are also recommended for both process characterization and regulatory submission.  They are also useful to evaluate and compare alternate resins and changes in upstream cell culture conditions.Product yield, impurity clearance, peak shape, elution volumes, elution pH, regeneration effectiveness and pressure drop can all drift after many cycles of operation.Due to the time involved in resin lifetime studies, the study design and planning are critical.  Practical advice on how to design re-use studies for Protein A resins, including minimizing the risk of scale up, will be presented including a general protocol and case studies that illustrate lifetime study results.


A Case Study: Comparison of Protein A Chromatographic Stationary Phases for Monoclonal Antibody Purification

Monoclonal antibodies and related proteins have firmly established themselves as the predominant formof biopharmaceuticals with a growing range of clinical applications.  Protein A chromatography represents the ideal platform for mAb purification, and the high cost of Protein A resins is a key motivator for the development of new affinity resins that offer increased binding capacities, improved retention of high binding at higher flow rates and base stability that permits sanitization using NaOH.  Data will be shown comparing JSR Amsphere A3 Protein A chromatographic resin with a range of currently available Protein A resins on the market.A comparative dataset was created for static binding capacity, dynamic binding capacities at various residence times, elution pH and purity profiles (host cell protein levels) for four mAb products produced in different cell lines and cell culture processes. The dynamic capacity data was employed to create productivity curves comparing the amount of product purified per unit resin volume per unit time.


Practical Protocol and Advice for Packing of Amsphere™ A3 resin

Packing of chromatography resins is not always a standard procedure.  Many factors that influence packing methodology and chromatography column performance include differences in column types, bed and column dimensions, pressure constraints, resin types, bed integrity criteria, compression factors and packing buffers.  Each of these will be discussed in the context of packing JSR Amsphere A3 affinity resin.


A Chinese CDMO Perspective: Selecting a Protein A Resin for Commercial Drug Manufacturing

Unlike large biopharma innovators, CDMO’s are challenged with a need to accommodate a wide spectrum of cell lines, mAb characteristics and variable titers.  This is also coupled with their clients’ varying needs for clinical material and supply chain considerations. The challenges, rationale and criteria for selecting an appropriate purification technology and chromatography resin will be discussed.

 



 

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时间

2017-10-19 08:45 - 开始

2017-10-19 13:00 - 结束

已结束
地点
  • 中国 上海 浦东新区
  • 上海浦东假日酒店