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Repligen技术研讨会

生物工艺新突破

以及行之有效的解决方案

thursday, October 24, 2019   |   Geneva, Switzerland

Repligen technical seminars are unique opportunities to discuss the changing landscape of bioprocessing with key thought leaders and experts around the world. Industry case studies in process intensification, continuous processing and flexible facilities allow you to learn from adopters of transformative technologies, evaluate risk landscapes and set the standards for modern bioproduction.

在2019年的研讨会中,将向您介绍标志着生物工艺市场转变的重大技术突破。

研讨会将在上海、华盛顿特区、旧金山、伦敦以及日内瓦举行。

点击此处 查看往届研讨会日程

Hotel President Wilson
47 Quai Wilson
CH-1211, Geneve 21

日程表

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摘要

ATF and TFF cell retention technologies were evaluated in our HDPB continuous process at lab and manufacturing scale. The filtration technologies were aligned at lab scale using common engineering criteria resulting in a comparable growth, productivity and product quality. A general overview of lessons learnt on the scalability, interchangeability and robustness at different scales will be given.

Contributors 

Joseph Shultz, Head-Biologics Technology & Innovation Strategy, Advanced Process and Manufacturing Technologies, Novartis Pharma
Ying Jing, Senior Strategy and Technology Leader, Cell Culture, Advanced Process and Manufacturing Technologies, Novartis Pharma

演讲人简历

David_Garcia.jpgDavid joined Novartis in 2015 and has been actively contributing to the development and scale-up/scale-down of new upstream bioprocesses. Prior to that, he obtained his PhD degree in Chemical Engineering / Bioprocessing from Imperial College London (2014) and his MSc in Biochemical Engineering from TUDelft (2007).

His research interests lie in the area of mammalian cell bioprocessing, scale-up/down, mathematical modelling, data analysis and optimisation.

摘要

The innovation team at Merck Serono is currently developing a continuous purification platform to support improvement of cell culture processes productivity. This presentation will emphasize the benefits of pre-packed purification technologies for the development of the Merck continuous purification process. The journey will span from robot assisted early development to final trials of the process at pilot scale, highlighting how Repligen solutions eased and facilitated several development activities

演讲人简历

Victor Pasquier.jpgVictor Pasquier is a process engineer specialized in protein purification at Merck Healthcare in Corsier-sur-Vevey, Switzerland. Since 2016, Victor is involved in technological and process innovation activities at Merck, including chromatography-related projects, process intensification, and next-generation processes development. Victor received his M.Sc. in biotechnology from the engineering school CPE Lyon, France.

摘要

In response to customers challenged with bioburden-sensitive TFF processes, technology leading single-use TangenX™ TFF flat sheet cassettes are now available in closed and irradiated format. Used in ultrafiltration and diafiltration, the new cassettes come pre-assembled and pre-tested, using the same proprietary membrane choices and multiple MWCOs as SIUS™ flat sheet cassettes. This session will demonstrate how the new cassettes integrate easily into any process with faster turnaround time, improved productivity and lower risk of contamination.

演讲人简历

Michaelmike-labreck.jpg LaBreck is Bioprocessing Sales Specialist for TangenX™ TFF products at Repligen starting in December 2016.  Before that, he supported the TangenX™ product line at NovaSep 2008- 2016. He has over 20 years experience with tangential flow filtration applications support in the biopharmaceutical industry.  He has held various sales and applications engineering positions with Pall Corporation and GE Healthcare. Michael has a Bachelor of Science degree in Mechanical Engineering from Syracuse University. 

摘要

Protein concentration defines the dosage a patient receives and therefore represents a critical quality attribute of fill-finished drug products. Process analytical tools monitoring this attribute and control the manufacturing process accordingly. This presentation will trace the FlowVPE technology implementation journey from initial laboratory feasibility tests to validation within an aseptic GMP facility of the. 

演讲人简历

raf_de-dier-picture.jpgRaf De Dier holds a Master’s degree in Chemical Engineering and obtained his PhD at the University of Leuven in Belgium and ETH Zürich in Switzerland. He joined Janssen R&D in 2016 as responsible for the process development and tech transfer support for liquid and lyophilized drug products in the parenteral fill-finish pilot plant. He currently works as a Senior Scientist Manufacturing Science and Technology, where he leads PAT and process improvement projects and manages activities such as concept, design and implementation of new equipment and technologies. 

摘要

Antibody–drug conjugates (ADCs) consist of a monoclonal antibody linked with a highly potent cytotoxic drug. The antibody primarily targets the drug to tumor cell receptors and secures internalization while the cytotoxic drug kills the targeted tumor cells.

Protecting both the product from environmental contaminants and the staff from exposure to the drug product are key manufacturing quality measures. While glass and stainless-steel systems may effectively protect operators, they require significant equipment decontamination and cleaning validation. As an alternative, single –use technologies offer specific benefits-but also come with their own challenges. Approaches and challenges to safe handling of both antibodies and high potency molecules (ADC, cytotoxic linker drug) will be presented.

演讲人简历

Ruud.jpgRuud Verstegen is DSP Process Engineer at Synthon Biopharmaceuticals based in Nijmegen in the Netherlands. He studied biochemistry at HAN University of Applied Sciences and has over 15 years work experience in the biopharmaceutical industry. His work experience includes development of veterinary viral vaccines at MSD Animal Health and development of human bacterial vaccines at Nobilon (Merck). Since 2011, he works within the Down Stream Processing department at Synthon BV, and is involved in process development for production of antibodies and antibody drug conjugates including scale-up, tech transfer to a GMP manufacturing facility and process validation.

摘要

As a bioprocessing innovator with technology expertise in filtration, Repligen has developed a breakthrough clarification and harvest technology that can signal a paradigm shift in mAbs and Gene Therapy bioprocessing. A result of continuous innovation at Repligen, the solution integrates advances in multiple disciplines, combining novel polymer technology, various filtration modes, hardware, systems and automated process management. Potential benefits to productivity, product quality, yield and workflow efficiency will be discussed.

演讲人简历

Parra, Shelly.jpgShelly Parra has over 20 years of experience in biotherapeutic process development, scale-up, technology transfer, manufacturing, and validation. She is currently the head of the global Field Applications team at Repligen and works with customers optimizing and scaling both upstream and downstream unit operations.  Prior to Repligen, Parra was employed at Thermo Fisher Scientific, Amgen, Transkaryotic Therapies, and BASF Bioresearch. She holds BS and MS degrees in Biotechnology from Worcester Polytechnic Institute in Massachusetts.

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参会不收取费用,但需要提前注册。因场地限制,仅限生物工艺工具和技术的终端用户参会。参会人员需自行负责交通、住宿及其它相关费用。提供午餐。

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