TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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Case Study - Mixing Validation • Investigation Approach Corrective Action Use same source for ref. std. for the buffer assay as used for excipient for buffer manufacturing 84
Case Study - Mixing Validation • Conclusion Simple thing like a source of an excipient when changed from animal- derived to vegetable-derived can have an impact on assay results 85
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TECHNOLOGY TRANSFER OF STERILE PROP
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Overview Current Status of Pharmac
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Status of Pharmaceuticals and Bioph
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Late-Stage Biotech Development (Sou
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Types of Technology Transfer Origin
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Phase IV Typical Drug Development P
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Needs for Technology Transfer Reaso
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Phases In Evolution of Production S
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Schematic to Summarize Technology T
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Technology Transfer Process/Phases
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Technology Transfer Process 2. Tech
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Technology Transfer Process 2. Tech
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Technology Transfer Process 3. Vali
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Technology Transfer Process 3. Vali
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Technology Transfer Phases 3. Proje
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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
Page 63 and 64: Hypothetical Technology Transfer (S
Page 71 and 72: Using CMO for Technology Transfer
Page 73 and 74: Technology Transfer Essentials Pro
Page 75 and 76: Technology Transfer Essentials Pro
Page 77 and 78: Technology Transfer Success Factors
Page 79 and 80: A Case Study Mixing Validation 79
Page 81 and 82: Case Study - Mixing Validation •
Page 83: Case Study - Mixing Validation •
Page 87 and 88: Thank you Questions 87
Page 89 and 90: Strategy for Characterization of Ra
Page 91 and 92: Air Classification Clean-Area Class
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TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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