The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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Published By Springer International Publishing

9783030137533, 9783030137540

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Manufacturing of Biopharmaceutical APIs

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_6 ◽

2019 ◽

pp. 177-208

Author(s):

John Geigert

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Priceless Potency (Therapeutic Activity)

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_10 ◽

2019 ◽

pp. 287-310

Author(s):

John Geigert

Keyword(s):

Therapeutic Activity

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Complexity of Biologics CMC Regulation

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_1 ◽

2019 ◽

pp. 1-31

Author(s):

John Geigert

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Demonstrating Product Comparability After Process Changes

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_14 ◽

2019 ◽

pp. 381-412

Author(s):

John Geigert

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Quality Attributes of a Biopharmaceutical

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_11 ◽

2019 ◽

pp. 311-329

Author(s):

John Geigert

Keyword(s):

Quality Attributes

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Biopharmaceutical Source Materials

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_5 ◽

2019 ◽

pp. 143-176

Author(s):

John Geigert

Keyword(s):

Source Materials

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Designing the Stability Program

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_12 ◽

2019 ◽

pp. 331-354

Author(s):

John Geigert

Keyword(s):

The Stability

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An Effective CMC Strategy is Possible

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_3 ◽

2019 ◽

pp. 53-87

Author(s):

John Geigert

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Product Characterization is a Journey

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_9 ◽

2019 ◽

pp. 261-285

Author(s):

John Geigert

Keyword(s):

Product Characterization

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Invaluable CMC-Focused Meetings with Regulatory Authorities

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals ◽

10.1007/978-3-030-13754-0_15 ◽

2019 ◽

pp. 413-421

Author(s):

John Geigert

Keyword(s):

Regulatory Authorities

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The Challenge of CMC Regulatory Compliance for BiopharmaceuticalsLatest Publications

TOTAL DOCUMENTS

H-INDEX

Published By Springer International Publishing

Manufacturing of Biopharmaceutical APIs

Priceless Potency (Therapeutic Activity)

Complexity of Biologics CMC Regulation

Demonstrating Product Comparability After Process Changes

Quality Attributes of a Biopharmaceutical

Biopharmaceutical Source Materials

Designing the Stability Program

An Effective CMC Strategy is Possible

Product Characterization is a Journey

Invaluable CMC-Focused Meetings with Regulatory Authorities

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Latest Publications