TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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Content of this presentation represent views of the speaker and does not indicate any past/current/future practices or philosophies of the employer of the speaker. 2
Overview Current Status of Pharmaceuticals and Biopharmaceuticals Products Technology Transfer of Sterile Drug Products Description, Needs, Types of Technology Transfer Technology Transfer Process Hypothetical Technology Transfer ‣ Scale-Up and Process Validation (Phase III/Commercial) Comparison of In-House vs. Using CMO Factors and Deliverables of Successful Technology Transfer of Sterile Products A Short Case Study Q&A 3
Page 1: TECHNOLOGY TRANSFER OF STERILE PROP
Page 5 and 6: Status of Pharmaceuticals and Bioph
Page 7 and 8: Late-Stage Biotech Development (Sou
Page 9 and 10: Types of Technology Transfer Origin
Page 11 and 12: Phase IV Typical Drug Development P
Page 13 and 14: Needs for Technology Transfer Reaso
Page 15 and 16: Phases In Evolution of Production S
Page 17 and 18: Schematic to Summarize Technology T
Page 19 and 20: Technology Transfer Process/Phases
Page 21 and 22: Technology Transfer Process 2. Tech
Page 23 and 24: Technology Transfer Process 2. Tech
Page 25 and 26: Technology Transfer Process 3. Vali
Page 27 and 28: Technology Transfer Process 3. Vali
Page 29 and 30: Technology Transfer Phases 3. Proje
Page 31 and 32: Schematic of Representative Bulk Pr
Page 33 and 34: Schematic of Representative Fill Fi
Page 35 and 36: Aseptic Manufacturing - Isolators V
Page 37 and 38: How to Conduct Technology Transfer
Page 39 and 40: Hypothetical Technology Transfer S
Page 41 and 42: Technology Transfer for Lyo Product
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Technology Transfer for Lyo Product
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Hypothetical Technology Transfer (S
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Using CMO for Technology Transfer
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Technology Transfer Essentials Pro
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Technology Transfer Essentials Pro
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Technology Transfer Success Factors
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A Case Study Mixing Validation 79
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Case Study - Mixing Validation •
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Thank you Questions 87
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Strategy for Characterization of Ra
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Air Classification Clean-Area Class
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TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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