| TÃtulo : |
Challenges in Protein Product Development |
| Tipo de documento: |
documento electrónico |
| Autores: |
Warne, Nicholas W., ; Mahler, Hanns-Christian, |
| Mención de edición: |
1 ed. |
| Editorial: |
[s.l.] : Springer |
| Fecha de publicación: |
2018 |
| Número de páginas: |
XVI, 599 p. 130 ilustraciones, 75 ilustraciones en color. |
| ISBN/ISSN/DL: |
978-3-319-90603-4 |
| Nota general: |
Libro disponible en la plataforma SpringerLink. Descarga y lectura en formatos PDF, HTML y ePub. Descarga completa o por capítulos. |
| Idioma : |
Inglés (eng) |
| Palabras clave: |
QuÃmica Farmaceútica Farmacia |
| Clasificación: |
615.19 |
| Resumen: |
En este volumen, los autores analizan los numerosos desafÃos importantes que se enfrentan actualmente en el desarrollo de formas farmacéuticas biotecnológicas, proporcionando orientación, experiencia compartida y una reflexión reflexiva sobre la mejor manera de abordar estas posibles preocupaciones. A medida que el campo de las proteÃnas terapéuticas recombinantes entra en su cuarta década y el mercado de productos biofarmacéuticos se vuelve cada vez más competitivo, las empresas dedican cada vez más recursos al desarrollo de productos biofarmacéuticos innovadores para abordar necesidades médicas no satisfechas. A menudo, el cientÃfico del desarrollo farmacéutico se encuentra con propiedades farmacéuticas desafiantes de una proteÃna determinada o con las demandas impuestas al producto por la estabilidad, la fabricación y las expectativas preclÃnicas o clÃnicas, asà como con las expectativas y el panorama regulatorio en evolución. Además, ha habido nuevos hallazgos que requieren una evaluación minuciosa, como por ejemplo los relacionados con la calidad del excipiente, el procesamiento, la viscosidad y la compatibilidad y administración del dispositivo, la solubilidad y la opalescencia y la selección del cierre del contenedor. La literatura varÃa ampliamente en su discusión de estos elementos crÃticos y no existe consenso. Este tema está recibiendo mucha atención dentro de la industria de la biotecnologÃa, asà como entre investigadores académicos y agencias reguladoras a nivel mundial. Por lo tanto, este libro es de interés para lÃderes empresariales, investigadores, cientÃficos de formulación y desarrollo de procesos, cientÃficos analÃticos, funcionarios de control de calidad, personal regulador, lÃderes de fabricación y reguladores activos en la industria farmacéutica y biotecnológica, y revisores expertos en agencias reguladoras. |
| Nota de contenido: |
Part 1. Formulation Development of Biologics -- Introduction into Formulation Development of Biologics -- Part 2. Challenges with Excipients -- Polysorbate Degradation and Quality -- Sucrose and Trehalose in Therapeutic Protein Formulations -- Part 3. High Concentration Proteins -- Introduction to High-Concentration Proteins -- Solubility, Opalescence & Particulate Matter -- Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations -- Practical Considerations for High Concentration Protein Formulations -- Part 4. Container-Closure Systems -- Parenteral Container Closure Systems -- Development of Prefilled Syringe Combination Products for Biologics -- Special Topics in Analytics of Pre-filled Syringes -- C Mini-Pumps -- Container Closure Integrity Testing of Primary Containers for Parenteral Products -- Chemical Durability of Glass – Delamination -- Part 5. Processing Considerations -- Bulk Protein Solution: Freeze Thaw Process, Storage and Shipping Considerations -- Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment -- Biotherapeutic Drug Product Manufacturing and Process Development -- Line Sterilization Considerations and VHP -- Lyophilization: Process Design, Robustness and Risk Management -- Fogging -- Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development -- Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product -- Part 6. Novel Constructs -- Introduction into Novel Constructs -- Novel Constructs – Half-Life Extensions -- Fc Fusion Proteins -- Part 7. Lifecycle Management -- Lifecycle Management of Biotherapeutic Dosage Forms -- Switching from an IV to an SC Formulation – Considerations for Formulation Development and Formulation Bridging. |
| Tipo de medio : |
Computadora |
| Summary : |
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies. |
| Enlace de acceso : |
https://link-springer-com.biblioproxy.umanizales.edu.co/referencework/10.1007/97 [...] |
Challenges in Protein Product Development [documento electrónico] / Warne, Nicholas W., ; Mahler, Hanns-Christian, . - 1 ed. . - [s.l.] : Springer, 2018 . - XVI, 599 p. 130 ilustraciones, 75 ilustraciones en color. ISBN : 978-3-319-90603-4 Libro disponible en la plataforma SpringerLink. Descarga y lectura en formatos PDF, HTML y ePub. Descarga completa o por capítulos. Idioma : Inglés ( eng)
| Palabras clave: |
QuÃmica Farmaceútica Farmacia |
| Clasificación: |
615.19 |
| Resumen: |
En este volumen, los autores analizan los numerosos desafÃos importantes que se enfrentan actualmente en el desarrollo de formas farmacéuticas biotecnológicas, proporcionando orientación, experiencia compartida y una reflexión reflexiva sobre la mejor manera de abordar estas posibles preocupaciones. A medida que el campo de las proteÃnas terapéuticas recombinantes entra en su cuarta década y el mercado de productos biofarmacéuticos se vuelve cada vez más competitivo, las empresas dedican cada vez más recursos al desarrollo de productos biofarmacéuticos innovadores para abordar necesidades médicas no satisfechas. A menudo, el cientÃfico del desarrollo farmacéutico se encuentra con propiedades farmacéuticas desafiantes de una proteÃna determinada o con las demandas impuestas al producto por la estabilidad, la fabricación y las expectativas preclÃnicas o clÃnicas, asà como con las expectativas y el panorama regulatorio en evolución. Además, ha habido nuevos hallazgos que requieren una evaluación minuciosa, como por ejemplo los relacionados con la calidad del excipiente, el procesamiento, la viscosidad y la compatibilidad y administración del dispositivo, la solubilidad y la opalescencia y la selección del cierre del contenedor. La literatura varÃa ampliamente en su discusión de estos elementos crÃticos y no existe consenso. Este tema está recibiendo mucha atención dentro de la industria de la biotecnologÃa, asà como entre investigadores académicos y agencias reguladoras a nivel mundial. Por lo tanto, este libro es de interés para lÃderes empresariales, investigadores, cientÃficos de formulación y desarrollo de procesos, cientÃficos analÃticos, funcionarios de control de calidad, personal regulador, lÃderes de fabricación y reguladores activos en la industria farmacéutica y biotecnológica, y revisores expertos en agencias reguladoras. |
| Nota de contenido: |
Part 1. Formulation Development of Biologics -- Introduction into Formulation Development of Biologics -- Part 2. Challenges with Excipients -- Polysorbate Degradation and Quality -- Sucrose and Trehalose in Therapeutic Protein Formulations -- Part 3. High Concentration Proteins -- Introduction to High-Concentration Proteins -- Solubility, Opalescence & Particulate Matter -- Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations -- Practical Considerations for High Concentration Protein Formulations -- Part 4. Container-Closure Systems -- Parenteral Container Closure Systems -- Development of Prefilled Syringe Combination Products for Biologics -- Special Topics in Analytics of Pre-filled Syringes -- C Mini-Pumps -- Container Closure Integrity Testing of Primary Containers for Parenteral Products -- Chemical Durability of Glass – Delamination -- Part 5. Processing Considerations -- Bulk Protein Solution: Freeze Thaw Process, Storage and Shipping Considerations -- Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment -- Biotherapeutic Drug Product Manufacturing and Process Development -- Line Sterilization Considerations and VHP -- Lyophilization: Process Design, Robustness and Risk Management -- Fogging -- Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development -- Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product -- Part 6. Novel Constructs -- Introduction into Novel Constructs -- Novel Constructs – Half-Life Extensions -- Fc Fusion Proteins -- Part 7. Lifecycle Management -- Lifecycle Management of Biotherapeutic Dosage Forms -- Switching from an IV to an SC Formulation – Considerations for Formulation Development and Formulation Bridging. |
| Tipo de medio : |
Computadora |
| Summary : |
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies. |
| Enlace de acceso : |
https://link-springer-com.biblioproxy.umanizales.edu.co/referencework/10.1007/97 [...] |
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Crear una solicitud de compra Refinar búsquedaAnalysis of Aggregates and Particles in Protein Pharmaceuticals / Mahler, Hanns-Christian ; Jiskoot, Wim.
