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Mastering CMC for Biologics - From IND to BLA

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1 - Introduction

1 - Introduction to the Course Mastering CMC for Biologics – From IND to BLA (Description).html

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1.9 KB

1 - Introduction to the Course Mastering CMC for Biologics – From IND to BLA.mp4

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17 MB

10 - CTD Module-3 Quality (CMC) Writing Tips & Strategy (Stage by Stage IND to BLA)

11 - Breakdown On Binding & Non-Binding Regulatory Conditions CTD Module 3 Quality

12 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)

13 - Biosimilars CMC Regulatory Strategy & Analytical Similarity

14 - Strategy A stepwise approach to CMC planning for BLA

15 - Real CMC Lessons – From IND to BLA

1 - Practice Test – Mastering CMC for Biologics.html

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79.7 KB

2 - Introduction of Biologics

2 - Introduction of Biologics (Description).html

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1.4 KB

2 - Introduction of Biologics.mp4

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120 MB

3 - Monoclonal Antibodies - The Model Biologics

3 - Monoclonal Antibodies - The Model Biologics (Description).html

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2 KB

3 - Monoclonal Antibodies - The Model Biologics.mp4

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106.8 MB

4 - Manufacturing Process of Monoclonal Antibodies

4 - Manufacturing Process of Monoclonal Antibodies (Description).html

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1.4 KB

4 - Manufacturing Process of Monoclonal Antibodies.mp4

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148 MB

5 - Cell Banking in Biologics

6 - Biologics Characterization

10 - Biologics Characterization Part-2.mp4

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111.5 MB

11 - Biologics Characterization Part-3.mp4

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129.8 MB

7 - Integrated Control Strategy & Comparability

12 - Integrated Control Strategy & Comparability-Part 1 (Description).html

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1.9 KB

12 - Integrated Control Strategy & Comparability-Part 1.mp4

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103.8 MB

13 - Integrated Control Strategy & Comparability-Part 2 Setting of Specifications.mp4

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65.4 MB

14 - Integrated Control Strategy & Comparability-Part 3 Comparability Study.mp4

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117.5 MB

8 - Stability Studies of Biologics

15 - Stability Studies of Biologics-Part 1 (Description).html

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1.7 KB

15 - Stability Studies of Biologics-Part 1.mp4

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141 MB

16 - Stability Studies of Biologics-Part 2 Extractable and Leachable (E&L).mp4

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26.6 MB

17 - Stability Studies of Biologics-Part 3 Shipping Qualification.mp4

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50 MB

9 - CTD Mapping – Modules 1 to 5

	18 - CTD Mapping - Module 1 to 5 (Description).html	HTML	1.4 KB
	18 - CTD Mapping - Module 1 to 5.mp4	MP4	34.1 MB

9 - Biologics Characterization Part-1 (Description).html

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1.9 KB

9 - Biologics Characterization Part-1.mp4

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104.4 MB

6 - Cell Banking in Biologics-Part 1 (Description).html

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1.8 KB

6 - Cell Banking in Biologics-Part 1.mp4

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59.1 MB

7 - Cell Banking in Biologics-Part 2.mp4

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82.2 MB

8 - Cell Banking in Biologics-Part 3.mp4

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105 MB

5 - Quality by Design (QbD) and Process Validation (Description).html

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1.5 KB

5 - Quality by Design (QbD) and Process Validation.mp4

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211.2 MB

28 - Apply real-world CMC lessons and regulatory insights to BLA (Description).html

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1.6 KB

28 - Apply real-world CMC lessons and regulatory insights to BLA.mp4

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120.7 MB

27 - Strategy-Planning For BLA (Description).html

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1.3 KB

27 - Strategy-Planning For BLA.mp4

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79.5 MB

26 - Biosimilars (Description).html

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1.7 KB

26 - Biosimilars.mp4

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69.8 MB

21 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 1 (Description).html

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1.8 KB

21 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 1.mp4

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459.4 MB

22 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 2.mp4

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81.7 MB

23 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 3.mp4

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95.5 MB

24 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 4.mp4

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109.9 MB

25 - Deep Dive into CTD MODULE 3 – QUALITY (3.2.S, 3.2.P & Appendices)-Part 5.mp4

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83.4 MB

20 - Established Conditions (PCs) Module 3 Quality (Description).html

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1.6 KB

20 - Established Conditions (PCs) Module 3 Quality.mp4

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102 MB

20 - SECTION_U-10_Breakdown on Binding & Non-Binding Regulatory Conditions.pptx

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11.1 MB

19 - CTD Module 3 Writing Tips (Description).html

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1.6 KB

19 - CTD Module 3 Writing Tips.mp4

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97.4 MB

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