近年來, 抗體藥物及基于抗體的治療藥物已經(jīng)逐步成為最重要的生物制品并且進(jìn)入到黃金發(fā)展時(shí)期. 據(jù)粗略估計(jì), 截止至2017年末, 美國(guó)藥品監(jiān)管單位已經(jīng)批準(zhǔn)上市了超過70種抗體藥物. 與此同時(shí), 生物制藥作為國(guó)家新型戰(zhàn)略產(chǎn)業(yè)之一,越來越多制藥公司開始建立, 布局生物制品部門及產(chǎn)品管線.  同時(shí)在2015年國(guó)家食品藥品監(jiān)督管理局也相繼發(fā)布了'關(guān)于生物類似藥研發(fā)與評(píng)價(jià)技術(shù)指導(dǎo)原則' 進(jìn)一步推動(dòng)了生物醫(yī)藥行業(yè)的快速發(fā)展. 第二屆抗體藥物開發(fā)暨工藝技術(shù)論壇, 將邀請(qǐng)60-70位在國(guó)內(nèi)外有影響力的專家, 著重討論抗體及治療性生物制品開發(fā), 分析與工藝開發(fā)技術(shù).

 

The Antibody and Antibody-based Therapeutics have entered the center stage of drug discovery. Roughly, as of end of 2017, over 70 antibody therapeutics have been approved. Not only in Western Countries, there have been also considerable biologics R&D, manufacturing and commercial activities in Asia. In 2015, the China FDA also received the country's first biosimilar guidelines to establish the basic principles for development and technical evaluation of biosimilars towards the adoption of a more concrete and well-defined regulatory pathway. In return, the 2018 Antibody-based Therapeutics and BioProduction Forum is to build up and facilitate the communication and partnerships to accelerate Biologics R&D, Characterization and Production.

 

迪易咨詢 Deliver Life Sciences

煙臺(tái)邁百瑞國(guó)際生物醫(yī)藥有限公司

澳斯康生物制藥（海門）有限公司

蘇橋生物（蘇州）有限公司

美中藥協(xié)費(fèi)城協(xié)會(huì) (SAPA-GP)

美中生物技術(shù)與制藥協(xié)會(huì) (SABPA)

抗體藥物產(chǎn)品開發(fā)及行業(yè)發(fā)展趨勢(shì)

抗體偶聯(lián)藥物研發(fā), 分析及工藝技術(shù)

雙特異性抗體, 創(chuàng)新及類似抗體藥物開發(fā)

高通量技術(shù)及創(chuàng)新平臺(tái)在抗體藥物研發(fā)及工程中的應(yīng)用

生物制品表征及分析技術(shù)

- Recent Trends and Development for Antibody Therapeutics

- The Development of Antibody Therapeutics in China

- Antibody-Drug Conjugates Development and Production

- Bispecific Antibodies and Similar/Novel Antibody Therapeutics

- Innovative Platform for Antibody Discovery and Engineering

- Biological Characterization Strategies

生物工藝開發(fā)創(chuàng)新技術(shù)

快速, 低成本臨床試驗(yàn)樣品制備策略

質(zhì)量控制, cGMP生產(chǎn)及外包策略

生物制劑, 蛋白聚集及穩(wěn)定性試驗(yàn)

細(xì)胞株及細(xì)胞培養(yǎng)工藝開發(fā)

連續(xù)工藝, 質(zhì)量源于設(shè)計(jì),過程分析技術(shù)與一次性系統(tǒng)

- Innovation in Biologics Manufacturing

- Integrated Strategies for Rapid Clinical Material Production

- Quality Control, cGMP Manufacturing and Externalization

- Biologics Formulation, Aggregation and Stability Studies

- Cell Culture Engineering and Downstream Processing

- Continuous Processing, QbD/PAT and Single-use Systems

6月15日前注冊(cè)將享有早期優(yōu)惠注冊(cè)價(jià)格, 

同時(shí)此次論壇提供2人及以上的團(tuán)體注冊(cè)優(yōu)惠；

 

 

聯(lián)系人：徐偉/David Xu                                        

聯(lián)系電話：+86 21 6131 5702 / +86 1377 6293 901 

Email: david.xu@deliver-consulting.com

會(huì)議網(wǎng)址: www.abbforum.com/

抗體藥物開發(fā)暨工藝技術(shù)論壇2018組委會(huì)

 

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