(額滿)【 Symposium 】Advancements in Pharmaceutical Technologies
2022/ 2/17~18 (0900~ 17:10) ;共二天
(On-Line)
【日期與時間】2022/ 2/17~18 (0900~ 17:10) ;共二天
【參加費用】
台灣經過二十餘年的努力，新藥開發已漸蓬勃發展，多項新藥進入人體試驗，假以時日必將台灣成功地推向世界舞台；同時，台灣早已建立一個成熟的原料藥及學名藥製劑產業，供給國內外需求。現今整合新藥開發與成熟製藥製造之供應鏈，以串鏈我國製藥產業各環節實屬當務之急，而其關鍵就在於將新的製藥技術及早應用於創新藥物製程開發，以加速新藥發展、降低未來製造門檻及成本以及大幅增加市場上之競爭力。
有鑑於此，新藥產業供應鏈聯盟(CMC Supply Alliance)及台灣生技產業發展學會之深耕學院(Bio-Industry Academy)聯合舉辦為期兩天之研討會，邀請各領域的學界專家與產業先進，共同探討原料藥及製劑產業之嶄新技術，以全力支援新藥開發，共創未來。
研討會第一天將介紹連續化製程技術以提升效率、降低能源消耗、減少廢棄物、提升安全及降低成本，包括小分子原料藥與製劑、生物藥前後端的製程發展，及使用製程分析技術(Process Analytical Technology)執行有效的生產品質監控；研討會也將探討運用各項粉粒體工程技術，解決難溶性藥物的溶解、吸收問題等。 此外，運用在光學活性化合物的合成上，具有高選擇性及高能源效率的酵素法製程，近年來已成為另一項熱門的話題，新冠疫苗中的mRNA的合成方式是in vitro transcription，也屬於一種酵素法製程，適用於不能於固態合成器生產的mRNA。 相對於單株抗體，酵素法製程比較容易放大、控制及純化。
第二天則聚焦於製劑技術，介紹採用固態分散、熱熔擠出、奈米化技術等來解決藥物溶解速率過慢的問題，同時介紹長效微球技術、眼科用藥的發展、及探討藥品體內外表現之關連性(IVIVC)；於新世代產品開發方面，則介紹ADC及mRNA藥物之發展。
兩天的研討會特別著重在工業經驗的分享，精彩可期；期待關心製藥產業技術之發展與應用的業界同仁，研究機構，學校教授與同學共襄盛舉。
【贊助廠商】
本次活動感謝以下協力企業大力促成及推動
(依廠商登錄贊助順序排序,持續更新與新增中)
安基生技新藥股份有限公司、鼎晉生技股份有限公司、台灣神隆股份有限公司、智擎生技製藥股份有限公司、台新藥股份有限公司、永昕生物醫藥股份有限公司、台耀化學股份有限公司、台康生際股份有限公司、全福生物科技股份有限公司、祥翊製藥股份有限公司、新雙隆生技股份有限公司、中大生醫股份有限公司、保瑞藥業股份有限公司、臺灣永光化學工業股份有限公司、免疫功坊股份有限公司、友華生技醫藥股份有限公司、南光化學製藥股份有限公司、英屬開曼群島商先知生物科技股份有限公司台灣分公司,中化合成生技股份有限公司,中化合成生技股份有限公司、瑞士藥廠股份有限公司,永日藥品工業股份有限公司, 松瑞製藥股份有限公司 (持續更新與新增中)
With more than 2 decades of dedicated efforts, the new drug development efforts in Taiwan started to show significant progress with many new drugs entering clinical trials. It is foreseeable that the commercial performance of a number of these products will be able to proudly demonstrate the outstanding drug development capabilities in Taiwan on the global market. Meanwhile, the world-class capabilities of CDMOs for drug substances & drug products (partially via generic business) have long been well recognized by the global pharma clients. It is crucial is to quickly integrate the new drug development movement with the locally mature CDMO capabilities to timely form a complete and competitive supply chain. And, the timing of involving CDMO in contributing their advanced technologies to the early stage of new drug development is absolutely essential in order to speed up the development, reduce the scale up hurdles & production costs, minimize entry barriers at commercialization, and greatly enhance the overall competitiveness at the market.
Based on these objectives, to provide dedicated support to new drug development, CMC Supply Alliance and Bio-Industry Academy (BIA, a working group at TBIO) decided to co-organize a two-day symposium and invited the various subject matter experts from academia and industry to jointly explore the advanced pharmaceutical technologies.
On Day 1, the theme will include Continuous Flow which will lead to energy conservation, waste reduction, safety enhancement and significant cost reduction. The technologies will be applicable to drug substances & drug products for both small molecules & biological products. To ensure the quality of the continuous flow process, the Process Analytical Technology will also be covered for continuous quality testing & control. The second theme will be Particle Engineering, which will involve discussion of various technologies in modifying the physical properties of drugs to resolve issues of drugs being difficult to dissolve or having absorption problems. The third theme will be for Enzymatic Reactions, which have always been considered as a highly selective and energy efficient optical synthetic process for optically active APIs. They have become very popular in recent years, since the mRNA in COVID-19 is produced with a technology called in-vitro transcription which is an enzymatic reaction, and it is best used for those mRNA cannot be produced using solid phase synthesizer. Comparing to monoclonal antibody process, the enzymatic process is also less complicated in scaleup, control & purification.
On the second day, discussions will be focused on the drug product technologies. To solve the drug low solubility problems, the hot melt extrusion & nanonization will be introduced. In addition, the long-acting microsphere technology, advancements in ophthalmic formulations plus the challenges of reaching In-Vitro In-Vivo Correlation (IVIVC) for IR & SR products will be addressed. In addition, the next generation drug technologies including the development of ADC and mRNA will also be reviewed.
The entire symposium will focus on the practical & industrial experience sharing. We look forward to the active participations from the new drug development community, the pharmaceutical industry, the research institutions, and the Universities.
【Date】2022/ 2/17~18 (am 0900~ pm05:10) (On-line)
【Fee】
【諮詢專線】02-2783 6028 分機11或分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權，如有變動將會提前通知)
【日期與時間】2022/ 2/17~18 (0900~ 17:10) ;共二天
【參加費用】
- 企業報名(廠商或團體) :NT10,000(頻寬考量,限每公司,三台主機連線,包括: 手機, 筆電,平板等硬體工具)
- 個人報名:NT3,500(每人)
- 現職大專院校老師(相關領域或科系者)及被其推薦參加之在學學生(可免費參加)
- 方式1 【企業報名】我要報名 (團體報名)
- 方式2【個人報名】已額滿(個人及校園)
台灣經過二十餘年的努力，新藥開發已漸蓬勃發展，多項新藥進入人體試驗，假以時日必將台灣成功地推向世界舞台；同時，台灣早已建立一個成熟的原料藥及學名藥製劑產業，供給國內外需求。現今整合新藥開發與成熟製藥製造之供應鏈，以串鏈我國製藥產業各環節實屬當務之急，而其關鍵就在於將新的製藥技術及早應用於創新藥物製程開發，以加速新藥發展、降低未來製造門檻及成本以及大幅增加市場上之競爭力。
有鑑於此，新藥產業供應鏈聯盟(CMC Supply Alliance)及台灣生技產業發展學會之深耕學院(Bio-Industry Academy)聯合舉辦為期兩天之研討會，邀請各領域的學界專家與產業先進，共同探討原料藥及製劑產業之嶄新技術，以全力支援新藥開發，共創未來。
研討會第一天將介紹連續化製程技術以提升效率、降低能源消耗、減少廢棄物、提升安全及降低成本，包括小分子原料藥與製劑、生物藥前後端的製程發展，及使用製程分析技術(Process Analytical Technology)執行有效的生產品質監控；研討會也將探討運用各項粉粒體工程技術，解決難溶性藥物的溶解、吸收問題等。 此外，運用在光學活性化合物的合成上，具有高選擇性及高能源效率的酵素法製程，近年來已成為另一項熱門的話題，新冠疫苗中的mRNA的合成方式是in vitro transcription，也屬於一種酵素法製程，適用於不能於固態合成器生產的mRNA。 相對於單株抗體，酵素法製程比較容易放大、控制及純化。
第二天則聚焦於製劑技術，介紹採用固態分散、熱熔擠出、奈米化技術等來解決藥物溶解速率過慢的問題，同時介紹長效微球技術、眼科用藥的發展、及探討藥品體內外表現之關連性(IVIVC)；於新世代產品開發方面，則介紹ADC及mRNA藥物之發展。
兩天的研討會特別著重在工業經驗的分享，精彩可期；期待關心製藥產業技術之發展與應用的業界同仁，研究機構，學校教授與同學共襄盛舉。
【贊助廠商】
本次活動感謝以下協力企業大力促成及推動
(依廠商登錄贊助順序排序,持續更新與新增中)
安基生技新藥股份有限公司、鼎晉生技股份有限公司、台灣神隆股份有限公司、智擎生技製藥股份有限公司、台新藥股份有限公司、永昕生物醫藥股份有限公司、台耀化學股份有限公司、台康生際股份有限公司、全福生物科技股份有限公司、祥翊製藥股份有限公司、新雙隆生技股份有限公司、中大生醫股份有限公司、保瑞藥業股份有限公司、臺灣永光化學工業股份有限公司、免疫功坊股份有限公司、友華生技醫藥股份有限公司、南光化學製藥股份有限公司、英屬開曼群島商先知生物科技股份有限公司台灣分公司,中化合成生技股份有限公司,中化合成生技股份有限公司、瑞士藥廠股份有限公司,永日藥品工業股份有限公司, 松瑞製藥股份有限公司 (持續更新與新增中)
With more than 2 decades of dedicated efforts, the new drug development efforts in Taiwan started to show significant progress with many new drugs entering clinical trials. It is foreseeable that the commercial performance of a number of these products will be able to proudly demonstrate the outstanding drug development capabilities in Taiwan on the global market. Meanwhile, the world-class capabilities of CDMOs for drug substances & drug products (partially via generic business) have long been well recognized by the global pharma clients. It is crucial is to quickly integrate the new drug development movement with the locally mature CDMO capabilities to timely form a complete and competitive supply chain. And, the timing of involving CDMO in contributing their advanced technologies to the early stage of new drug development is absolutely essential in order to speed up the development, reduce the scale up hurdles & production costs, minimize entry barriers at commercialization, and greatly enhance the overall competitiveness at the market.
Based on these objectives, to provide dedicated support to new drug development, CMC Supply Alliance and Bio-Industry Academy (BIA, a working group at TBIO) decided to co-organize a two-day symposium and invited the various subject matter experts from academia and industry to jointly explore the advanced pharmaceutical technologies.
On Day 1, the theme will include Continuous Flow which will lead to energy conservation, waste reduction, safety enhancement and significant cost reduction. The technologies will be applicable to drug substances & drug products for both small molecules & biological products. To ensure the quality of the continuous flow process, the Process Analytical Technology will also be covered for continuous quality testing & control. The second theme will be Particle Engineering, which will involve discussion of various technologies in modifying the physical properties of drugs to resolve issues of drugs being difficult to dissolve or having absorption problems. The third theme will be for Enzymatic Reactions, which have always been considered as a highly selective and energy efficient optical synthetic process for optically active APIs. They have become very popular in recent years, since the mRNA in COVID-19 is produced with a technology called in-vitro transcription which is an enzymatic reaction, and it is best used for those mRNA cannot be produced using solid phase synthesizer. Comparing to monoclonal antibody process, the enzymatic process is also less complicated in scaleup, control & purification.
On the second day, discussions will be focused on the drug product technologies. To solve the drug low solubility problems, the hot melt extrusion & nanonization will be introduced. In addition, the long-acting microsphere technology, advancements in ophthalmic formulations plus the challenges of reaching In-Vitro In-Vivo Correlation (IVIVC) for IR & SR products will be addressed. In addition, the next generation drug technologies including the development of ADC and mRNA will also be reviewed.
The entire symposium will focus on the practical & industrial experience sharing. We look forward to the active participations from the new drug development community, the pharmaceutical industry, the research institutions, and the Universities.
【Date】2022/ 2/17~18 (am 0900~ pm05:10) (On-line)
【Fee】
- Company registration:NT10,000 ( only for 3 sites, )
- Idividual registration: NT3,500 (Per person)
- 【Company registration】Click here
- 【Individual/Campus registration】
| Day 1 02/17 ( Thu ) | ||||||
| Time | Subject | Speaker | Organization | |||
| 09:00 09:05 | 1-1 Opening Drug Manufacturing Technologies - Key to the Competitiveness of New Drug Development | 吳永連董事長 Dr. Yonlian Wu | 祥翊製藥 Sunny Pharmtech | |||
| 09:05 09:45 | 1-2 Continuous Flow - Drug Manufacturing for the Future | Dr. Bayan Takizawa Co-Founder, Chief Business Officer | Continuus Pharmaceuticals | |||
| 09:45 10:25 | 1-3 Microreactor for Continuous Manufacturing - Recent Development and Commercial Successes. | 楊立勔博士 Dr. Barry Yang Vice President | 瑞林科技顧問有限公司 Richlink Technology Consulting Co. | |||
| 10:25 10:30 | Break | |||||
| 10:30 11:10 | 1-4 Application of Continuous Processing in Biopharmaceutical Manufacturing | 周維宜協理 Dr. Alvan Chou Associate Vice President | 永昕生物科技股份有限公司 Mycenax Biotech Inc | |||
| 11:10 11:50 | 1-5 Fundamentals of Simulated Moving Bed Chromatography and Its Applications and Opportunities in Pharmaceutical Industry | 梁明在博士 Dr. Ming-Tsai Liang Director | 喬璞科技公司 Jope Technology CO. LTD. | |||
| 11:50 12:50 | Lunch | |||||
| 12:50 01:30 | 1-6 Particle Design Using Supercritical Fluid Technology and Sonocrystallization Process | 蘇至善教授 Professor Chie-Shaan Su | 台北科技大學化學工程與生物科技系 Department of Chemical Engineering & Biotechnology National Taipei University of Technology | |||
| 01:30 02:10 | 1-7 Orchestration of API Polymorphism | 李度教授 Professor Tu Lee | 中央大學 化學工程與材料工程學系 Department of Chemical and Materials Engineering, National Central University | |||
| 02:10 02:15 | Break | |||||
| 02:15 02:55 | 1-8 Spray Drying Technologies to Address Dissolution Challenges | 林彥志博士 Dr. Yen-Chih Lin Associated Director, Manufacturing | 祥翊製藥股份有限公司 Sunny Pharmtech, Inc 原藥生產處副處長 | |||
| 02:55 03:35 | 1-9 Recent Experiences in Applying Hot Melt Extrusion Technology | 黃唯婷副處長 Dr. Wendy Huang Deputy Director | 財團法人醫藥工業技術發展中心 藥品製劑研發處 Department of Pharmaceuticals, Medical and Pharmaceutical Industry Technology and Development Center | |||
| Enzymatic Process | ||||||
| 03:35 04:15 | 1-10 Competitive Advantages of Enzymatic Chemical Process | 陳勇發博士, Dr.Yung Fa Chen Chairman | 松瑞醫藥生技股份有限公司 SLC BioPharm | |||
| 04:15 04:45 | Panel Discussion Chair: Dr. Yon-Lian Wu Panelists: Dr. Barry Yang, Dr. Pei-Jiun Chen, Dr. Ming-Tsai Liang, Professor Raynor Su, Professor Tu Lee, Dr. Yen-Chih Lin , Dr. Wendy Huang, Dr.Yung-Fa Chen | |||||
| 04:45 05:05 | Closing Remarks | 馬海怡博士 Dr. Jo Shen | CMC Alliance Organizer Venture Partner, Vivo Capital Board of Director, Taiwan Bio Industry Organization | |||
| Day 2 02/18 ( Fri ) | ||||||
| Time | Topic | Speaker | Organization | |||
| 09:00 09:05 | 2-1 Critical Challenges in Drug Formulation - Experience & Innovation | 呂瑞梅博士 Dr. Maggie Lu 組長 Director | 工研院生醫所 標靶藥物與傳輸技術組 Targeted Drug and Delivery Technology Division, BDL, Industrial Technology Research Institute | |||
| 09:05 09:45 | 2-2 Formulation Continuum from animal to human studies: IVIVC Case studies on IR and SR formulation | 顧曼芹總經理 Dr. Sherry Ku President | 顧德諮詢有限公司 Kuder Consulting Company | |||
| 9:45 10:25 | 2-3 Overview and Challenges of Ophthalmic Formulations | 廖玲瑛 諮詢顧問 Ling-Ying Liaw Consultant | 美力齡生醫股份有限公司 Merry Life Biomedical Company, Ltd. | |||
| 10:2510:30 | Break | |||||
| 10:30 11:10 | 2-4 Overview of Menthodlogies of Solid Dispersion for Difficult to Dissolve Compounds | 彭成毅 研發副總 Dr. David Perng VP, R&D | 祥翊製藥 Sunny Pharmtech | |||
| 11:10 11:50 | 2-5 Translational Development of Amorphous Pharmaceutical Materials | 王宏仁總經理 Dr. Hong-Ren Wang President/CEO | 智擎生物製藥股份有限公司 PharmaEngine, Inc. | |||
| 11:50 12:50 | Lunch 中場休息 | |||||
| 12:50 1:30 | 2-6 Enhanced Druggability Through APNT: Novel Drug Particle Nanolization & Formulation Techniques | 陳佑汲 處長 Dr. Yu-Chi Chen Director | 奈米發展處 台新藥股份有限公司, Nanotechnology Development Formosa Pharmaceuticals, INC | |||
| 1:30 2:10 | 2-7 The Trend of Lipid Nanoparticles Technologies for mRNA - Next Wave of Vaccine & New Drugs | 鄭平福副理, Dr. Ping-Fu Cheng Deputy Project Manager | 工研院生醫所藥物傳輸技術部 Drug Delivery Technology Department, BDL, ITRI | |||
| 2:10 2:15 | Break 中場休息 | |||||
| 2:15 2:55 | 2-8 The Key Advantages for Long-Acting Microsphere for New Chemical Entities Development | 羅友文廠長, Dr. Eric Lo, Plant Manager | 工研院生醫所藥物傳輸技術部 Drug Delivery Technology Department, BDL , ITRI | |||
| 2:55 3:35 | 2-9 The mRNA Development and Manufacturing | 楊靜仁研究員 Dr. Ching-Jen Yang Research Fellow | 財團法人生物技術開發中心 生物工程 Development Center for Biotechnology│Bioengineering Department | |||
| 3:35 4:15 | 2-10 Trends and Technology of Antibody-Drug Conjugates - Critical Aspects of CMC Preparation | 鄭淑珍經理 Dr. Felice Cheng Manager | 工研院生醫所藥物傳輸技術部 Drug Delivery Technology Department, BDL, ITRI | |||
| 4:15 4:45 | Panel Discussion Chair: Dr. Sherry Ku Panelists: Dr. Maggie Lu, Ling Ying Liaw, Dr.David Perng, Dr. Hong-Ren Wang, Dr. Yu-Chi Chen, Dr. Ping-Fu Cheng, Dr. Eric Lo, Dr. Ching-Jen Yang, Dr. Felice Cheng | |||||
| 4:45 5:05 | Closing Remarks | 馬海怡博士 Dr. Jo Shen | CMC Alliance Organizer Venture Partner, Vivo Capital Board of Director, Taiwan Bio Industry Organization | |||
【諮詢專線】02-2783 6028 分機11或分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權，如有變動將會提前通知)