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Choosing the proper long-term manufacturing strategy - system comparison


Description: All antibodies currently on the market are manufactured by the mammalian cell culture technology, and it is clearly the leading technology at the moment. However, there are a number of negative factors linked to this technology that can be minimized or avoided by using other production technologies. The mammalian cell culture technology is represented by a strategic overview-based approach in comparison with the transgenic plant and animal platforms.

Multiple factors affecting manufacturing decisions by potential clients are highlighted in our analysis:

-The cost of setting up the manufacturing platform (initial capital outlay)
-Scaling up the manufacturing process
-The expression level of biologics
-Purification costs
-Validation, regulation, environmental and ethical concerns
-Therapeutic safety (immunogenicity) and activity of the protein product in relation to glycosylation
-Intellectual property hurdles

The actual cost associated with transgenic therapeutics can be significantly higher than expected due to the substantial significance of purification. Creative purification technologies such as purification by centrifugation, protein crystallization, fusion to protein-based polymers, which aggregate upon temperature shift, or fusion to oilbodies and oilbody-linked ligands might create a greater cost advantage for transgenic systems.

Above mentioned multiple factors affecting manufacturing decisions by potential clients are highlighted and analyzed in Choosing the proper long-term manufacturing strategy - system comparison –business intelligence analysis.

The report details key issues driving manufacturing investment in the pharmaceutical sector. Analysis includes thorough business intelligence analysis of technology solutions that can be consolidated into a (finite) number of areas. Vendors need to be able to approach customers with an understanding of industry dynamics, and how their solutions will address them. By reading the analysis you are able to understand the key areas that will drive the growth of transgenic manufacturing industry in the next 5 years and plan your strategy accordingly.


Contents: 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




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