Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin.
Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries.
Contents
- The Development of Animal Cell Products: History and Overview
Fundamental Elements of Cell Growth Media
- Water Purity and Regulations
- Development and Optimization of Serum-free and Protein-free Media
- Understanding Animal Sera: Considerations for Use in the Production of Biological Therapeutics
Cell Engineering for Recombinant Products
- Expression of Recombinant Biomedical Products from Continuous Mammalian Cell Lines
- Production of Recombinant Viral Vaccine Antigens
- A Brief Overview of the Baculovirus Expression System in Insect and Mammalian Cells
- Stability: Establishing Clones, Genetic Monitoring and Biological Performance
- Gene Transfer Vectors for Clinical Applications
Technology and Facilities for Cell Culture Scale-Up
- Systems for Cell Culture Scale-up
- Process Development and Design
- Facility Design for Cell Culture Biopharmaceuticals
- Monitoring, Control and Automation in Upstream Processing
- Services and Associated Equipment for Upstream Processing
- System and Process Validation
Processing and Preservation of Cells and Products
- Cell Harvesting
- Protein Concentration
- Purification Methods
- Virus Safety of Cell-Derived Biological Products
- Formulation and Freeze Drying for Lyophilized Biological Medicines
- Cell Preservation
Properties of Cell Products
- Product Characterization from Gene to Therapeutic Product
- Protein Analysis
- Glycosylation of Medicinal Products
- Immunogenicity of Impurities in Cell-Derived Vaccines
- Potency and Safety Assessment of Vaccines and Antitoxins: Use of Cell-based Assays
- Product Stability and Accelerated Degradation Studies
Cells as Products
- Cell Culture in Tissue Engineering
- The Use of Stem Cells in Cell Therapy
- Cells as Vaccines
Risk Assessment and Regulatory Aspects
- Risk Assessment of Cell Culture Procedures
- Standardization of Cell Culture Procedures
- Good Laboratory Practice for Cell Culture Processing
- Good Manufacturing Practice for Cell Culture Processing
- International Regulatory Framework
- New Areas: Cell Therapy and Tissue Engineering Products- Technical, Legal and Regulatory Considerations
Index
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