1.Biologics manufacturing decision and the choice of contract manufacturing 2.Strategy overview – comparison of biologics production technologies 2.1.Setting up the manufacturing platform (initial capital outlay) 2.2.Scaling up the manufacturing process 2.3.Expression level of biologics 2.4.Purification costs 2.5.Validation, regulation, environment and ethical concerns 2.6.Therapeutic safety (immunogenicity) and activity of the protein product in relation to glycosylation 2.7.Intellectual property hurdles 2.8.Other factors affecting manufacturing decisions by potential clients 2.9.Other manufacturing systems
Tables and figures:
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 cell bioreactor Table VI. COGS vs. annual requirement, transgenic plants and animals
Figure I. Manufacturing strategy for pharmaceutical products Figure II.Purification process for monoclonal antibodies Figure III. Plant-based biologics regulation in the USA
