【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
 【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
 
【諮詢專線】02-77003883 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)