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    Home > Medical News > Latest Medical News > "Biopharmaceutical process key point" hard core dry goods, you pay attention to me all have!

    "Biopharmaceutical process key point" hard core dry goods, you pay attention to me all have!

    • Last Update: 2020-07-31
    • Source: Internet
    • Author: User
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    Introduction: August 24-26, 2020 (4th) Biopharmaceutical Technology Development Summit will be held in Shanghai.
    -Trade-Friendly Medical Biopharmaceutical Technology Development Summit (BPD) has been successfully held three times before.
    this year, August 24-26, 2020 (4th) Biopharmaceutical Technology Development Summit will be held in Shanghai, this conference together with the strategic organizers of the pharmaceutical ming biology, co-host of The Pandoning Biology, Lishou Technology, the Special Commission of the institutions Baiji Shenzhou, Junshi biology, Fuhong Hanxuan, Tianyi biology, Newforth biology, look forward to the industry friends at home and abroad gathered together! This conference brings together more than 50 professional big curry industry aims to create a biopharmaceutical technology industry benchmark meeting, directly poke the process pain point, interpret the process problems, and jointly promote the industry take-off! The essence of the conference, come soon! Biopharmaceutical Technology Overview and New Technology Progress Panel Planner: Zhou Weichang, Executive Vice President and Chief Technology Officer, Pharmaceutical Ming Bio ★ Accelerated Development and Production of New Crown Virus (SARS-CoV-2) Neutralizing Anti★★bodies Guest: Zhou Weichang, Executive Vice President and Chief Technology Officer, Pharmaceutical Biology Outline: Using the most advanced innovative technology platform and strategy, effectively improve sedative efficiency, greatly shorten the development and production of new crown virus (SARS-CoV-2) Anti-drug process development strategy ★ New technology platform in antibody drug technology development application guest: Jiang Weidong, co-founder and chief scientific officer, Fu Hong Hanxuan ★ guest interview: biopharmaceutical from development to commercialization process discussion host: Zhou Weichang interviewee: Jiang Weidong, Liu Jian, Zhang Zheru, Lu Hongxuan antibody drug upstream process mastermind: Jiang Weidong, co-founder and chief scientific officer★, Senior Director of Upstream Process Development, Fu Hong Hanxuan Outline: 1, Continuous Flow Process Introduction 2, Application of Continuous Flow Process in Upstream 3, Example Analysis ★ BiolikeScaleScaleModeling: Quality and Affordab guest: Ran Zhaoxiang, Senior Vice President, Tris★ Process Change sedative at all stages of clinical consideration guest: Qiao Junhua, pharmacy Vice President of Development Department, Tianyi Bio★ Over-enhanced upstream process to enhance the flow plus training production guest: Han Xiangzong, upstream technical research and development director, Merck outline: With the rapid development of continuous flow production process, more and more new drug development began based on continuous flow or part of the continuous flow of production process development, greatly improve the process development cycle and unit volume production efficiency, and ultimately reduce the production costs of biopharmaceuticals.
    but most of the biologic drugs that have been approved for sale in the past few decades still use traditional fluid-plus culture processes, and how to maximize the use of traditional fluid-plus culture processes to further increase yields has become the focus of the current process.
    in addition to the traditional media development and flow-and-cultivation process development, some combined with the concept of continuous flow production of the enhanced flow and culture process more and more favored by the industry, can obtain a significant increase in output, while ensuring that product quality is basically unaffected.
    ★ The new generation of rapid high-expression cell cell line development process guests: Zhang Wei, deputy director of cell line building department, pharmaceutical biology outline: 1, the impact of cryptoon on protein production 2, cell line construction strategy to accelerate the new crown project approval 3, second generation sequencing technology in cell line construction application antibody-type drug downstream process mastermind: Liu Wei, deputy general manager, Hengrui Pharmaceutical ★ early development of the process consideration point guest: Wang Guan, vice president★, Guests: Chen Yuanyuan, Deputy Director of Virus Removal Research Department, Pharmaceutical Biology ★ Speech Topics To be presented guests: Cytiva Stufan ★ the pulse downstream process development - host cell protein impurity removal guest: Lin Shiwen, Vice President of downstream process development department, Pharmaceutical Biology Outline: Host Cell Protein (HCP) as the production of mandatory cells brought or process-related impurities, regulatory and industry standards must be required to remove antibodies from any recombinant biological drugs.
    this requirement also brings to researchers in the field of biopharmaceutical liquid development one of the methods and criteria for the development of the pulse downstream purification process, so that the rationality of the operation and development of each step unit can be measured.
    pharmaceutical biology has established an effective host cell protein impurity removal platform, respectively, can be flexible against mono-ireactor, dual-resistance, fusion protein, non-antibody recombinant protein and enzymes, to meet strict international industry standards.
    this presentation will share these effective strategies and show examples of tomography including filling and wash screening, sample processing and filtration.
    ★ Guest Interview: Commercial Process Development Strategy Antibody Drug Industrialization Process Mastermind: Yan Hong, Senior Vice President, Cinda Bio; Liu Jian, General Manager, Baiji Shenzhou Biopharmaceutical★ Design, Construction and Validationa World Class Stainless Steel Steel Steel Material Seion Yasi Guest: Michael Garvey, Vice President, Baiji Shenzhou Outline: 1, Engineering Design and Construction ★ to establish a quality control audit platform in line with international standards guest: Lu Renhao, deputy director of quality department-QC, Cinda bio outline: how to face the international market, prepare for national audit (EMA, FDA, NMPA, PAI) platform construction? ★ Sedolis self-control platform and multi-variable real-time analysis integration program guest★: Wang Wei, China upstream product manager, Sedolis outline: 1, bio-control development trend★; Outline: 1, single anti-drug quality control function 2, quality control elements in the research and development process 3, NDA declaration content quality control points 4, commercial product production, annual report 5, after listing change ★ integrated CMC capability makes a number of biological analogy development to global guests: Liu Cuihua, senior vice president, Baiotai outline: 1, biological analogy different stages to the listing of international development strategy to meet the needs of globalization 2, Baxter's CMC platform technology capabilities 3, The cMC internationalization milestones in the two cases share ★ new design concept of a one-time system and a local guest of Saint-Gobain: Liu Jiaying, product manager, Saint-Gobain (China) Life Sciences Outline: In recent years, the rapid development of single-use products in biopharmaceutical process applications, especially in the application of mono-resistance has also contributed to its rapid entry into commercial production harvest period.
    in the fierce competition in the biopharmaceutical market, improve the matching of disposable product systemand and process, shorten the process preparation time and ensure the safety of one-time product supply, thus greatly shorten the production cycle, achieve efficient drug development and production, become the key to success.
    ★ phase quality system and cGMP in the biological products development process application guest: Yao Yanping, senior quality director, Baiji Shenzhou outline: 1, what is the phase of the quality system 2, phase quality system consideration points 3, the application of quality management norms in different stages of development★ quality standards based on the QbD concept and analytical method life cycle management guest: Zhang Wei, the executive director of the Quality Control Department, the pharmaceutical biology outline: this speech mainly discusses the concept of the former
    new drug technology development special planner: Xiao Yan, co-founder, Newforth; Deng Liang, senior director of macromolecular biology department, Beida Pharmaceuticals ★ gene therapy carrier adenosis-related virus mass production challenge guest: Wang Lijun, CTO, Hangzhou Jiain Biotech Co., Ltd. outline: In recent years, the use of adenosis-related viruses (AAV) as a vector for gene transfer in the body more and more clinical trials, the carrier has a good degree of safety. the increasing demand for larger indications and systemic treatments in
    has increased the demand for cGMP viruses for clinical and future commercial use by several orders of magnitude.
    this lecture will discuss the challenges of mass production of AAV virus vectors, including the latest manufacturing platforms and technologies, achieving process repeatability, and exploring CMC analytical methods and the latest drug regulatory requirements.
    ★ adenovirus vector in advanced treatment technology and its industrialization guest: Liang Wei, founder/general manager, Shanghai Jins Biotechnology Co., Ltd. outline: adenovirus vector is one of the first virus vectors used in gene therapy and tumor virus therapy, and is also the first to complete the industrialization technology and drug research and development full cycle of virus carrier.
    this report will describe the background of research and development of adenovirus vector, related biological characteristics, especially the application prospects of the carrier in advanced therapeutic technology and the current situation of the development of its industrialization technology.
    ★ adeno-related virus upstream process case sharing and emerging technology overview guest: Xiao, co-founder, Newforth ★ guest interview: China Gene and Cell Treatment to international commercialization path interview guests: Wang Gang, Gao Kai, Wang LiqunICH practice depth analysis of the special planner: Zhang Zheru, President★, Tianyi Biology; ★ Management Guest on Process Change after the listing of biopharmaceuticals: Wang Gang, Senior Vice President and Chief Quality Officer of Industrial Affairs, Junshi Bio★ Process Characterization Research and Practice Guest in China: Nake, Technical Deputy Director, Jige Biological ★ Strategy For Cell Line Construction and Process Development in accordance with ICH Principles: Tao Weihong, Head of Cell Line Construction and Process Development, Andding Pharmaceutical Symme Cell line construction and process development organic combination strategy thinking 3, case sharing - mainly introduces the monoclonal antibody drug industry using host cells, expression carriers, transfection methods, screening strategies and cell culture process, combined with project experience, according to the principle of ICH, to explore the key points of cell line construction and the organic combination of cell line construction and process development.
    ★ method confirmation and validation guests for different stages in accordance with ICH guidelines: Xu Yiren, Director of the Department of AnalyticScience, Pharmaceutical Biology Outline: According to ich guidelines, analytical methods for different clinical phase samples need to be developed to confirm or validate strategies.
    in response to the need for rapidly advancing new crown projects, Pharmacoine Bio has pioneered the use of joint validation strategies to ensure the rapid advancement of the new crown project and to lay the foundation for methodological validation of clinical requirements in the late stages of the new crown project.
    this strategy has also been recognized by the regulatory departments of Singapore, China and other countries, and a number of new crown projects developed on behalf of The drug Ming Bio have been approved by IND in these regions to conduct a clinical trial.
    supply chain localization host: Chen Ting, cell department and production director, Jiangsu Corning Jerry Biopharmaceutical Co., Ltd. ★ speech topic to be decided guests: Liu Lin, senior researcher, pharmaceutical ming bio★ one-time pipeline in the biopharmaceutical industry application guest: Yan Jian, general manager, bright black technology ★ online liquid system in the single anti-downstream process application and cost advantage guest: Wang Zhi, North District Manager, Lishou Technology ★ high-flow, high-efficiency, high-efficiency, high-efficiency Media research and development and production guests: Zhang Hong, General Manager, Boglon Bio-Empowered Biopharmaceutical Industry Eco-Chain Host: Li Zesheng, Chief Operating Officer and Senior Vice President, Teno Mabo ★ Innovative Biopharmaceutical Industry Chain and Biopharmaceutical Ecosystem With Chinese Characteristics Guest: Li Zesheng, Chief Operating Officer and Senior Vice President, Teno Mabo: 1, Supply Chain Innovation (Shorten Time) 2, Process Operation automation and Intelligence (Improving Quality) 3, Equipment (Cost Reduction) Capital market as a catalyst for the innovation industry chain★ the theme of the speech to be determined guests: Xingdeke more upstream service providers, downstream service providers, contract customized service outsourcers, regulatory/declaration consulting services, supply chain service providers, financial service providers, industrial parks in the opening of the opening of the conference opportunities, and jointly build the biopharmaceutical industry ecological chain.
    consulting phone: 021-51550463 Ms. Gu hot topic round table discussion selected industry hot topics, led by industry experts 10 people to discuss, solve practical process difficulties, only 3 groups of places, first report first,report first, report full and stop! 1) Countermeasures for CMC process changedurings during clinical development; 2) key points of biological activity analysis and verification, 3) Thinking about reducing production costs and preparing tidbits thank the experts of the General Assembly for planning the current biopharmaceutical technology industry benchmark meeting to jointly promote industrial development! Attend the consultation phone: 01-51550463 Ms. Gu online consultation, scanning the next two-dimensional code conference registration, more opportunities to get planners and speakers one-on-one question-and-answer opportunities! Sponsorship Enquiry Phone: 18516293589 E-mail: assistant_healthcare@enmore.com booth sold out, more forms of sponsorship, fast booking! Add a small assistant to the easy-to-trade medical WeChat.
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