Includes bibliographical references and index.

Online resource; title from PDF title page (EBSCO, viewed May 4, 2015).

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.

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 into a therapeutic agent. This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophy.