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Monoclonal antibodies : meeting the challenges in manufacturing, formulation, delivery and stability of final drug product /
Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam :
Woodhead Publishing is an imprint of Elsevier,
[2015]
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| Colección: | Woodhead Publishing series in biomedicine ;
no. 77. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Related titles; Monoclonal Antibodies; Copyright; Contents; List of figures; List of tables; About the author; Preface; 1
- Introduction; Pharmaceutical development; Development of the API; mAbs as protein therapeutics; Brief review of mAb structure; References; 2
- Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs); Analytical methods for evaluation of monoclonal antibody stability; References; 3
- Stability of monoclonal antibodies (mAbs); Degradation routes in monoclonal antibodies; Chemical degradation; Mechanisms of oxidation.
- Nonenzymatic peptide fragmentationNonreducible cross-linking in mAbs; Physical degradation; Exposure to air/water interfaces due to agitation; Use of large-scale pumps in DP unit operations; Filtration; Filling; Adsorption to surfaces; References; 4
- Formulation of proteins and monoclonal antibodies (mAbs); Formulation of monoclonal antibodies; Buffers for pH control; Ionic strength and tonicity modifiers; Surfactants and surface-active agents; Antioxidants; Protein Stabilizers; References; 5
- Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs).
- Extractables and leachables from IV bags and impact on protein/mAb stabilityReferences; 6
- Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs); The challenge of formulating at high concentration; Impact on delivery due to high viscosity at high mAb concentrations; Impact on manufacturing of high-concentration SC formulations due to high viscosity; Bioavailability of a high-concentration mAb formulation for SC delivery; Development of analytical tools for high-concentration formulation development; References.
- 7
- Strategies to deal with challenges of developing high-concentration subcutaneous (SC) formulations for monoclonal antibodies (mAbs)Using existing manufacturing technologies through redesign of equipment or modification of process variables to produce high-con ... ; Development of alternative processes/formulations for manufacturing of high-concentration dosage forms; Using formulation excipients to reduce viscosity; References; 8
- Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration.
- Using delivery devices to deliver large volume mAb formulations by the subcutaneous routeDelivery of viscous solutions using a prefilled syringe; The technical challenges for device and formulation development; Primary container/closure systems for devices to be used with mAbs; Silicone oil interactions with proteins and mAbs in prefilled syringes; Impact of leachables from prefilled syringe components; Potential interactions with stainless steel needles; Potential problems with tungsten in prefilled syringes; Filling of highly concentrated mAbs into prefilled syringes; References.
- 9
- The molecular basis of high viscosity of monoclonal antibodies (mAbs) at high concentration.