(恭喜結業)【雙證書】一次瞭解不可不知的生物製劑CMC實務養成班: 24小時
2022/09/03、9/17、9/24、10/1 每週六(09:30~12:30 / 13:30~16:30)
一次瞭解不可不知的生物製劑CMC實務養成班: 24小時
雙證書:結業證書+測驗合格證書，協助學員掌握關鍵知識、技術及內化應用能力！
【課程簡介】
Biologic CMC是成功發展生物藥的重要關鍵，特別是生物藥的複雜性及面對法規的不同階段對安全性及一致性的要求。本課程將從策略面及法規面引導學員有效率規劃生物藥CMC的開發，並以各開發階段實務的成功與失敗案例及經驗融入課程中；包括：生物藥的關鍵原料細胞株開發、上游製程、下游製程、生產製造及品質管控與規格制訂等，逐一引導學員縱貫所有CMC在生物藥物開發中所面臨的關鍵技術及不同階段的法規要求，能使學員所執行的專案成功並準時完成IND與BLA送件。
【適合對象】學界及產業人員與主管、有蛋白藥物開發與製造相關知能需求之從業人員
【課程規劃專家】劉理成 總經理、張志榮副總經理 (台康生技)
【上課日期/時間】2022/09/03、9/17、9/24、10/1
每週六(09:30~12:30 / 13:30~16:30)
【測驗時間】結業當天下午進行測驗(4:30~5:30 時間: 1小時) 線上測驗
【線上報名】我要報名<---- 請點選
【上課地點】(線上同步課程 ,平台使用:zoom)
【課程預排表】<時數配當表-預排> 配合期末測驗考試,2022版課程已更新!
| 課程名稱 | 授課講師 | 時數 | 重點內容 |
| 1 Comprehensive of biologic CMC strategy and practice | 劉理成 總經理 | 2 | · Challenges and opportunities for biologics |
| · Good strategy and practice for biologic CMC | |||
| · Case studies | |||
| 2 Challenges of adventitious agents control includes sources materials for biologics | 馮仁佑 執行協理 | 2 | · Introduction of adventitious agents |
| · The challenges of adventitious agents control | |||
| · Theregulations of adventitious agents | |||
| · Case studies | |||
| 3 Development of production cell lines and microbial strains for biologics | 陳盈君 經理 | 2 | · Overview of cell line generation |
| · Key factors of production and regulatory success for cell line development | |||
| 4 Key of upstream process development and risk management and process characterization | 雷博欽 副協理 | 3 | · Introduction to upstream process development and scale up process |
| · Risk management and process characterization | |||
| · QbD and PAT in upstream processing | |||
| · Single-use technology in biopharmaceutical manufacturing | |||
| 5 Sufficient downstream steps and relative processes to support biologics submission | 吳燦輝 協理 | 3 | · Introduction of downstream protein purification by chromatography or others. |
| · Purification strategy for impurities removal | |||
| · Purification optimization to meet the requirement of biologics submission | |||
| 6 How to reduce risk for biologics manufacturing includes technical transfer and process validation pathway | 朱勝忠 製造總監 | 3 | · Biologic process development |
| · Cell line, upstream and downstream consideration | |||
| · Biologic manufacturing and PPQ/process validation pathway | |||
| · Tech transfer, GMP product consideration | |||
| 7 Regulation of the variations occurred before and after license approval | 李元鳳 執行協理 | 1.5 | · Planning the changes |
| · Regulation and guidance | |||
| · Document management after approval | |||
| 8 Good quality control & characterization of biologics | 潘奕璿 資深經理 | 1.5 | · Integration between analysis, process development and manufacturing |
| · Product characterization | |||
| · Functional activity | |||
| · Characterization and analysis strategy | |||
| · Conclusion | |||
| 9 Smart to set specification and expiration date of biologics | 林藹寧 執行協理 | 1 | · General principles of QC testing |
| · Category of QC testing | |||
| · Strategy for setting QC specification | |||
| · Strategy for expiry dates | |||
| · Example | |||
| 10 Regulatory requirement of product similarity & comparability | 林藹寧 執行協理 | 1 | · Background introduction |
| · Goal of the comparability study | |||
| · Comparability study design | |||
| · Comparability protocol | |||
| · Extreme comparability of biosimilars | |||
| · Example | |||
| 11 Drug product process and manufacturing | 葉宏鈞 副協理/陳菁櫻 執行協理/ | 4 | · Introduction of drug product |
| · Biologic drug product development | |||
| · Drug product manuacturing and risk management for commercialization | |||
| · Drug product device development and regulatory consideration |
【線上報名】我要報名<---- 請點選
【證書資格】雙證書資格及核發辦法，參考如下:(線上測驗)
- 【結業證書】須出席滿80%時數以上 (20小時)，結業當天現場核發
- 。未取得【結業證書】者，將無法參加期末測驗，亦將影響您取得【測驗合格證書】，請留意!
- 【測驗合格證書】為協助學員掌握關鍵知識、技術及內化應用，並驗證課程設計與學習之有效性，亦參照TTQS訓練品質系統及手冊、ADDIE課程設計之精神等，本梯次將統一辦理期末測驗，各主題單元須達:70分以上(滿分:100分)，參考題型:選擇題、簡答、申論等類 ,將於課程最後一天安排測驗(16:30~17:30)，訓後1個月內於學院官網將公告【測驗合格名單】並開始寄發考試合格證書。證書效期:3年，發照單位:台灣生物產業發展協會，如無須取得本證書者當日可免參加考試。本考試無法補考，證書遺失或需補發工本費為:NT:500元，效期無法展延。
- 如有未詳盡事宜可來電洽詢
【課程費用】
- 非團體會員NT$16,800
- 協會團體會員NT$ 15,600
- 早鳥優惠價:NT 14,400( 延至8/10日前完成報名及繳費)