【CMC系列】一次瞭解不可不知的生物製劑CMC課程 (額滿停招/已結業)
2018/ 10/06(六)~10/20 (額滿停招/已結業)
【生物製劑CMC系列】
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。
【課程名稱】一次瞭解不可不知的生物製劑CMC課程
【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
【上課時間】2018/10/6~10/20，共3週，18小時，每週六9:30-12:30 / 13:30-16:30
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓)
【課程費用】共18小時，非團體會員NT$11,700，協會團體會員NT$9,000。
【預約/報名】(額滿停招)
(注意事項:以上課程大綱及開課日期/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)
<課程預排>
| 上課日期 | 時數 | 課程名稱 | 授課講師 | |
| 10/06(六) 09:30~:11:00 | 1.5 | Comprehensive of biologic CMC strategy and practice | · Challenges and opportunities for biologics | 劉理成 總經理 |
| · Good strategy and practice for biologic CMC | 台康生技 | |||
| · Case studies | ||||
| 10/06(六) 11:00~12:30 | 1.5 | Challenges of biologics CMC Regulation | · Global regulatory definition of biologics | 盧瀗鍹 博士 |
| · EMA biologic regulation and complex US laws for regulation of biologic drugs | 生技顧問 | |||
| · ICH guidelines on quality and control | ||||
| · Differences between chemical drugs and biologics | ||||
| · Biosimilars and guidelines | ||||
| · Case studies | ||||
| 10/6(六) 13:30~16:30 | 3 | Development of production cell lines and microbial strains for biologics | · Overview of cell line generation | 陳佩君 總經理 |
| · Key factors of production and regulatory success for cell line development | ||||
| 金樺生醫 | ||||
| 10/13(六) 09:30~11:30 | 2 | Key of upstream process development for fit biopharmaceutical industry needs | · Introduction to upstream process development | 雷博欽 副協理 |
| · Scale up of upstream processing | 台康生技 | |||
| · QbD and PAT in upstream processing | ||||
| · Single-use technology in biopharmaceutical manufacturing | ||||
| 10/13(六) 11:30~12:30 | 2 | Sufficient downstream steps and relative processes to support biologics submission | · Introduction of downstream protein purification by chromatography or others. | 吳燦輝 協理 |
| 13:30-14:30 | · Purification strategy for impurities removal | 台康生技 | ||
| · Purification optimization to meet the requirement of biologics submission | ||||
| 10/13(六) 14:30~16:30 | 2 | How to reduce risk for biologics manufacturing | · Biologic process development | 何明 副總經理 |
| · Cell line, upstream and downstream consideration | 台康生技 | |||
| · Biologic manufacturing | ||||
| · Tech transfer, GMP product consideration | ||||
| 10/20(六) 09:30~11:30 | 2 | Good quality control & characterization of biologics | · Integration between analysis, process development and manufacturing | 林藹寧 資深協理 |
| · Product characterization | 台康生技 | |||
| · Functional activity | ||||
| · Characterization and analysis strategy | ||||
| · Conclusion | ||||
| 10/20(六) 11:30~12:30 | 2 | Smart to set specification and expiration date of biologics | · General principles of QC testing | 林藹寧 資深協理 |
| 13:30~14:30 | · Category of QC testing | 台康生技 | ||
| · Strategy for setting QC specification | ||||
| · Strategy for expiry dates | ||||
| · Example | ||||
| 10/20(六) 14:30~16:30 | 2 | Regulatory requirement of product similarity & comparability | · Background introduction | 林藹寧 資深協理 |
| · Goal of the comparability study | 台康生技 | |||
| · Comparability study design | ||||
| · Comparability protocol | ||||
| · Similarity of biosimilars | ||||
| · Example |