【セミナー情報】ModernaのVice PresidentのSatish Singh先生など、遺伝子治療・ワクチンの分野で世界をリードする先生方が東京で講演します！

ユー・メディコでは、2023年9月15日、御茶ノ水ソラシティカンファレンスセンターにおいて、遺伝子治療・ワクチンの分野で世界をリードするご講演者の皆様に日本にお越しいただき、対面形式にてセミナーを開催する運びとなりました。本セミナーは、大変好評をいただいた2012、2014、2016、2019年に続く、5回目の開催となります。
アメリカ、ヨーロッパ、日本の各分野の第一人者から、ワクチンや遺伝子治療に関する最新情報を得ることができる貴重な機会です。さらに、展示ブースでは最先端の装置や有用な情報を提供しております。また、講演者と直接交流することのできる懇親会も予定しております。
バイオ医薬品、遺伝子治療薬およびワクチンの安定性、分析、製剤開発、原薬および製剤の製造プロセスに興味をお持ちのかたは是非ご参加ください。

開催概要

日時：2023年9月15日（金）10:00-18:00（予定）18:00~懇親会
場所：御茶ノ水ソラシティカンファレンスセンター
主催者：株式会社ユー・メディコ
後援：Coriolis Pharma Research GmbH
ウェブサイト：https://u-medico.co.jp/event/biopharmaseminar2023

講演者

Dr. Satish Singh (Vice President, Drug Product Development, Moderna, Inc.)
“mRNA products – A platform approach to formulation and process development”
mRNA製品 –  製剤およびプロセス開発へのプラットフォーム・アプローチ
mRNA-based vaccines revolutionized the response to the Covid-19 pandemic, and ongoing developments with this “novel” therapeutic modality show enormous potential. A significant advantage with the technology is the ability to use a platform approach to formulation and process development, which includes the lipid nanoparticles (LNP)-based delivery system. In the case of mRNA-LNP products (with specific focus on vaccines), the technology enables a platform approach that has elements that are sequence-specific as well as sequence-agnostic. A deep understanding of the process and its impact on CQAs and thereby function has been developed over multiple programs. Ultimately, a robust control strategy can be created for mRNA-LNP products, leveraging information from these programs.
The talk will cover aspects of formulation, process and product function and outline the platform approach.

Dr. Sandeep Yadav (Sr. Director, Head of Vector Design, Vector Process Development (DS) and Formulation & Fill/Finish (DP), Sangamo Therapeutics)
“Challenges and Opportunities with AAV derived genomic medicines – a CMC perspective”
AAV由来ゲノム医薬品の課題と可能性 – CMCの観点から
Adeno-Associated viruses (AAVs) are being extensively leveraged to deliver therapeutic DNA for Genomic medicine applications. The industry however is still in early stages of gaining experience with stability, analytics, and DS & DP mfg. processes with notable CMC challenges around extremely low titers, limited mfg. lots to develop process knowledge, complex analytical methodologies required to characterize AAV systems etc. Collectively these challenges lead to higher COGs while catering to the rare/orphan disease space. This talk focusses on CMC challenges and strategies to reduce/optimize COGs and enable patient convenience and access.

Prof. Dr. Susumu Uchiyama (大阪大学工学研究科生命先端工学専攻高分子バイオテクノロジー領域 教授, 株式会社ユー・メディコ取締役・最高技術顧問)
“Current status and challenges of analysis and quality control of AAV vectors”
AAVベクターの分析および品質管理の現状と課題
Detailed and comprehensive analyses of virus vectors are required to ensure their efficacy and safety. Recently, novel biophysical characterization methods of AAV have emerged. Here we introduce primary structure analysis by the combination of information from CE-SDS and LC-MS, which also provides an accurate ratio of VPs. Then, multiwavelength SV-AUC will be introduced that enables to identify comprehensive size distribution profile of particles with information on constituents in AAV samples.

Dr. Tim Menzen (Chief Technology Officer (CTO), Coriolis Pharma Research GmbH)
“Analytical Techniques for Particles in Biopharmaceutical Formulations for Therapeutic Proteins, Viruses, Vaccines, and Cells”
治療用タンパク質、ウイルス、ワクチン、細胞のバイオ医薬品製剤における粒子の分析技術
In his presentation, Dr. Tim Menzen will introduce you to the broad field of particle characterization for biopharmaceuticals. He will outline the various types of particles relevant in biopharmaceutical industry, ranging from impurities and degradation products like protein aggregates to particulate formulations such as viral vectors and living cells. His talk will further present analytical tools available for the characterization of particles in various size ranges. On the example of case studies, Dr. Menzen will describe how a broad analytical portfolio of orthogonal methods is used for the reliable sizing, quantification, differentiation and identification of particles in the nanometer, micrometer and visible size range.

Prof. Dr. Gerhard Winter (Chair of Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-University Munich) 
“Stabilization of AAV Vector Formulations by Lyophilization”
凍結乾燥によるAAVベクター製剤の安定化
Long-term storage stability of AAV vector formulations has not yet reached a satisfactory level. Aqueous virus supensions can have a surprisingly high stability, particularly when using relatively high ionic strength, but when it comes to storage times that are required for a marketable product, they fail. Freeze drying on the other hand does not lead to satisfying results right away. Dehydration of the viruses/formulations is difficult, even when well known water-replacements formulations are applied. At that point we have studied the dehydration and stabilization of AAV formulations in detail and come up with proposals how to design promising freeze dried AAV products.


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