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Outsourcing of Development and Manufacturing
· Finding the CMO's that have the right capabilities and the best match to provide development and/or manufacturing services for the production of proteins
· Provide assistance and guidance in developing contracts that work for the client
· Technology transfer
· Act as liaison with selected CMO
Plant Design
· Review of conceptual and detailed design (including PID's) to ensure cGMP compliance, proper flow, future flexibility and expansion
· Bioreactor design and specification
· Equipment specification and selection
· Suggestions for easier operations and maintenance
· Site selection
· Assist with local and state officials
Selection of Engineering and Construction Contractors
· Review of available and qualified companies
· Evaluation of proposed teams
· Owner's representative from negotiations to start-up
Process Evaluation
· Selection of batch, fed-batch or perfusion
· Scalability and robustness evaluation of process
· Evaluation of manufacturing strategy
Troubleshooting of Existing Plants and Processes
· Contamination control
· Yield improvements
· Addition of new products
Cost Evaluation
· Cost of Goods analysis and forecasts
· Capital cost review
· Value Engineering
Operations
· Staffing plans
· Staff selection
· Community relations
Business Strategic Decisions
· Perform due diligence on potential acquisitions or partners
· Assist in "make or buy" decisions
· Find potential partners for excess capacity
© BioWorks Consulting, 2004 - 2007