Chapter 1. Biologics manufacturing decision and the choice of contract manufacturing
Chapter 2. Strategy overview – comparison of biologics production technologies
Setting up the manufacturing platform (initial capital outlay)
Scaling up the manufacturing process
Expression level of biologics
Purification costs
Validation, regulation, environment and ethical concerns
Therapeutic safety (immunogenicity) and activity of the protein product in relation to glycosylation
Intellectual property hurdles
Chapter 3. Other factors affecting manufacturing decisions by potential clients
Chapter 4. Other manufacturing systems
List Of Tables
Table I. Percentage of drug companies with in-house biologics manufacturing capabilities.
Table II. Lead-time for plant building
Table III. Cost breakdown of new facility
Table IV. Comparison of different manufacturing systems based on 1 ton protein
Table V. Biologics production potential of a mammalian bioreactor
Table VI. COGS vs. annual requirement, transgenic plants and animals
List Of Figures
Figure I . Manufacturing strategy for pharmaceutical products
Figure II. Purification process for monoclonal antibodies
Figure III. Plant-based biologics regulation in the USA
