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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert |
| Autore | Geigert John |
| Edizione | [4th ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (597 pages) |
| Disciplina | 615/.19 |
| Soggetto topico |
Biologicals
Biopharmaceutics Pharmaceutical chemistry Pharmacy Biologics Pharmaceutics |
| ISBN | 3-031-31909-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities. |
| Record Nr. | UNINA-9910731488803321 |
Geigert John
|
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| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert |
| Autore | Geigert John |
| Edizione | [3rd ed. 2019.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
| Descrizione fisica | 1 online resource (338 pages) |
| Disciplina | 615.7 |
| Soggetto topico |
Pharmacology
Pharmacy Pharmacology/Toxicology Drug Safety and Pharmacovigilance |
| ISBN | 3-030-13754-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Complexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities. |
| Record Nr. | UNINA-9910337940703321 |
|
Geigert John
|
||
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert |
| Autore | Geigert John |
| Edizione | [2nd ed. 2013.] |
| Pubbl/distr/stampa | New York, NY : , : Springer New York : , : Imprint : Springer, , 2013 |
| Descrizione fisica | 1 online resource (362 p.) |
| Disciplina |
610
615.15 615.19 615.3 |
| Soggetto topico |
Pharmaceutical technology
Medicine Pharmaceutical Sciences/Technology Biomedicine, general |
| ISBN | 1-4614-6916-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Complexity of Biologica CMC Regulation -- Biologics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Source Materials for Biologics -- Manufacture of the Biologic API -- The Biologic Final Product Process -- Complex Process-Related Impurities -- Molecular Structural Analysis -- Functional Activity (Potency) -- Setting Specifications and Expiry Dates -- Demonstrating Product Comparability -- CMC-Focused Regulatory Meetings -- References. |
| Record Nr. | UNINA-9910437854103321 |
|
Geigert John
|
||
| New York, NY : , : Springer New York : , : Imprint : Springer, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||