1. 總經理 黃一旭 博士 Michael Hwang, D.V.M., Ph.D. 永昕生物醫藥公司
生物新藥開發與市場
總經理 黃一旭 博士
Michael Hwang, D.V.M., Ph.D.
永昕生物醫藥公司
永昕生物醫藥
生技產業導論

2. 總經理 黃一旭 博士 永昕生物醫藥股份有限公司總經理 (現任) 美國 CR Rockville 科技部主任
行政院衛生署藥品查驗中心顧問
成都中醫藥大學新藥研究開發中心顧問
專長：
藥廠經營/管理，藥品開發， 業務推廣， 製藥法規及市場分析 學歷
台大獸醫學士,獸醫師 1977
美國路易西安那州西北大,碩士 1983
美國奧本大學,博士 1987
永昕生物醫藥
生技產業導論

3. 生物製劑的種類 Therapeutics Gene Therapy In Vivo Diagnostics
Therapeutic Vaccine
BioDevice
Tissue Repair
Xenotransplantation
Natural Product
永昕生物醫藥
生技產業導論

4. 生物製劑的特性
複雜高分子物質
三度空間結構特性
生物有效性或活性
需特殊安全測試
永昕生物醫藥
生技產業導論

5. Critical Parameters for Biologics
Safety (安全性）
Potency（強度）
Purity （純度）
Consistency （持續性）
Efficacy （有效性）
永昕生物醫藥
生技產業導論

6. Investigational New Drug Introduction/Distribution
新藥開發、製造、測試及申請流程
新藥開發
Drug Development
臨床前動物試驗
Pre-clinical
Development
申請審核新藥物
Investigational New Drug
Application (IND)
三階段人體臨床試驗
Clinical Development
申請藥物許可
BLA 上市
Introduction/Distribution
To the Market
永昕生物醫藥
生技產業導論

7. Phases and Quality Pre-Clinical - Close to cGMP
Phase I - cGMP w/ some changes
Phase II - cGMP w/ changes
Phase III - cGMP w/ No Changes
BLA - No More Product Development
永昕生物醫藥
生技產業導論

8. Process Development - Mission
To develop production processes of appropriate scale - from pre-clinical exploration to commercialization
永昕生物醫藥
生技產業導論

9. Process Validation Cell Culture Filtration Chromatography
Viral Clearance
Aseptic Manipulation Validation
Equipment
Other - cleaning, storage,transferring, packaging, and shipping
永昕生物醫藥
生技產業導論

10. Modification/formulation
Manufacturing Scheme
Host
Bank
Production
Purification
Modification/formulation
Packaging
永昕生物醫藥
生技產業導論

11. Manufacturing - Outline
Master Cell Bank & Working Cell Bank
Starting Material Production
Purification
Modification
Formulation
Aseptic Vialing
Labeling
永昕生物醫藥
生技產業導論

12. Clinical Trials Pre-Clinical & IND Phase I: Human Safety
Animal studies, safety, metabolic, pharmacological & process description
Phase I: Human Safety
Clinical pharmacology studies
永昕生物醫藥
生技產業導論

13. Clinical Trials Phase II: Efficacy
Controlled studies in patients with disease or condition
Blinded clinical evaluation
永昕生物醫藥
生技產業導論

14. Clinical Trials Phase III: Safety and Efficacy
Both controlled and open trials
Closely monitored by sponsor for adverse reactions and information to be used for setting dosage requirements and labeling.
永昕生物醫藥
生技產業導論

15. Clinical Trials Treatment: (Physician's IND; Compassion)
Involves patients with a serious, life threatening, or terminal illness when alternative treatment is not available or not effective and proposed treatment use has some evidence of effectiveness.
永昕生物醫藥
生技產業導論

16. Documentation Control
To reduce the risk of error due to oral or informal communication, to provide clear, written instructions, and to permit traceability.
永昕生物醫藥
生技產業導論

17. Document Training Record
Specifications (supplies, chemicals, products)
SOPs
Production Batch Records
Validation Records + Equipment IQ/OQ/PQ
Equipment use log
永昕生物醫藥
生技產業導論

18. CONTROL
A documented process by which validated procedures are consistently followed to eliminated unacceptable deviations from the established standards.

19. CONTROL General Controls Design Control Facility Control
Equipment Control
Material/Component Control
Operational Control
Finished Product Control
永昕生物醫藥
生技產業導論

20. 生物新藥市場評估 需求評估 New Case / Year Total Case / Year 用藥量 市場占有率 市場治療費用／年
永昕生物醫藥
生技產業導論

21. 生物新藥市場評估 製作評估 Patent /法律問題 製造困難度（量產／保存） 體內／外活性 劑量（單一／重複） 藥品壽命 永昕生物醫藥
生技產業導論

22. 生物新藥市場評估
Patent 費用
製造費用
臨床實驗費用
臨床實驗結果取得時間
永昕生物醫藥
生技產業導論

23. 生物新藥市場評估 Cost of Goods Price per dose Cost per patient 健保／保險業給付 市場接受度
永昕生物醫藥
生技產業導論