【製劑系列】2024版_一次瞭解不可不知的生物製劑CMC課程
2024/08/3~08/24 (每週六) (09:30~12:30 & 13:30~16:30)
【課程規劃專家】劉理成(台康總經理)及張志榮(台康副總經理)
【上課時間】2024/08/3~08/24 (每週六) (09:30~12:30 & 13:30~16:30)
【上課時數】24小時 (4天)
【上課地點】台北市大安區復興南路一段390號11樓(財團法人職訓研發中心) 暫訂
【課程費用】
1. 非會員課程定價:NT：21,000
2早鳥優惠價:NT：7/10 前完成線上報名及繳費只要 : 19,800
3 同公司或單位,3人以上報名可享優惠價:每人只要18,800
4 本會團體會員特別優惠價: NT 18,000
(如報名額滿 ,以本會團體會員優先錄訓)
【報名方式】 線上報名<<<----額滿為止
【課程及師資預排表】每周六上課
| 課程名稱 | 授課講師 | 上課日期 | 重點內容 |
| Comprehensive of biologic CMC strategy and practice | 劉理成 總經理 | 2024/8/3 | · Challenges and opportunities for biologics |
| 台康生技 | · Good strategy and practice for biologic CMC | ||
| · Case studies | |||
| Challenges of adventitious agents control includes sources materials for biologics | 劉理成 總經理 (TBD) | 2024/8/3 | · Introduction of adventitious agents |
| 台康生技 | · The challenges of adventitious agents control | ||
| · Theregulations of adventitious agents | |||
| · Case studies | |||
| Development of production cell lines and microbial strains for biologics | 陳盈君 經理 | 2024/8/3 | · Overview of cell line generation |
| 台康生技 | · Key factors of production and regulatory success for cell line development | ||
| Key of upstream process development and risk management and process characterization | 程方怡 副理 | 2024/8/10 | · Introduction to upstream process development and scale up process |
| 台康生技 | · Risk management and process characterization | ||
| · QbD and PAT in upstream processing | |||
| · Single-use technology in biopharmaceutical manufacturing | |||
| Sufficient downstream steps and relative processes to support biologics submission | 吳燦輝 協理 | · Introduction of downstream protein purification by chromatography or others. | |
| 台康生技 | 2024/8/10 | · Purification strategy for impurities removal | |
| · Purification optimization to meet the requirement of biologics submission | |||
| How to reduce risk for biologics manufacturing includes technical transfer and process validation pathway | 朱勝忠 製造總監 | 2024/8/17 | · Biologic process development |
| 台康生技 | · Cell line, upstream and downstream consideration | ||
| · Biologic manufacturing and PPQ/process validation pathway | |||
| · Tech transfer, GMP product consideration | |||
| Regulation of the variations occurred before and after license approval | 李元鳳 執行協理 | 2024/8/17 | · Planning the changes |
| 台康生技 | · Regulation and guidance | ||
| · Document management after approval | |||
| Good quality control & characterization of biologics | 潘奕璿 資深經理 | 2024/8/17 | · Integration between analysis, process development and manufacturing |
| 台康生技 | · Product characterization | ||
| · Functional activity | |||
| · Characterization and analysis strategy | |||
| · Conclusion | |||
| Smart to set specification and expiration date of biologics | 林藹寧 執行協理 | · General principles of QC testing | |
| 台康生技 | · Category of QC testing | ||
| 2024/8/24 | · Strategy for setting QC specification | ||
| · Strategy for expiry dates | |||
| · Example | |||
| Regulatory requirement of product similarity & comparability | 林藹寧 執行協理 | 2024/8/24 | · Background introduction |
| 台康生技 | · Goal of the comparability study | ||
| · Comparability study design | |||
| · Comparability protocol | |||
| · Extreme comparability of biosimilars | |||
| · Example | |||
| Drug product process and manufacturing | 吳燦輝 協理/張家豪副研究員 | 2024/8/24 | · Introduction of drug product |
| · Biologic drug product development | |||
| · Drug product manuacturing and risk management for commercialization | |||
| · Drug product device development and regulatory consideration |
1. 非會員課程定價:NT：21,000
2早鳥優惠價:NT：7/10 前完成線上報名及繳費只要 : 19,800
3 同公司或單位,3人以上報名可享優惠價:每人只要18,800
4 本會團體會員特別優惠價: NT 18,000
(如報名額滿 ,以本會團體會員優先錄訓)
【報名方式】 線上報名<<<----額滿為止
【諮詢專線】(02)2783-6028 分機11或 分機12 歡迎來電
(以上課程大綱及開課日期及授課師資等; 本協會保有異動權，如有變動將會提前通知)