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1. Creating an effective contract manufacturing organization

2. Current CMO Reality Outsourcing bites! Complex & diverse programs Long development times Risk, risk and more risk www.bioprocessingalliance.com

3. The Challenge... Contract Manufacturers are faced with: Client relationship management challenges Complex, sometimes historical or ‘broken’ processes Timeline and budget constraints Delivering the project with client satisfaction Mitigating process failure in Manufacturing Suites www.bioprocessingalliance.com

4. www.bioprocessingalliance.com GMP Manufacturing (Clinical) Potential Client Investigative Troubleshooting & Additional Process Development to Resolve Issue Detailed Scope of Work & Internal Cost Work-Up YES Did process scale? Is it GMP? Comparable to confirmation and engineering runs? NO Engineering Run (Pre-Clinical, Tox or RS) Signed Contract YES NO Did process scale? Comparable to confirmation run(s)? Technology Transfer Existing Process Scale-Up into Manufacturing Limited Process Robust, consistent, predictable and scalable process? Development Plan Confirm Lab-Scale Process (Final Confirmation) Create Batch Records NO Resolution: Corral the Project Laboratory Functions Mfg. Suites Design the organization to systematically ‘Corral’ every project the same way. Protect ‘expensive’ mfg. space from process failure. Introduce 3 ‘gates’ to channel the project and manage client expectations. YES

5. Layering for Ultimate Success www.bioprocessingalliance.com GMP Manufacturing (Clinical) Potential Client Investigative Troubleshooting & Additional Process Development to Resolve Issue Detailed Scope of Work & Internal Cost Work-Up YES Did process scale? Is it GMP? Comparable to confirmation and engineering runs? NO Engineering Run (Pre-Clinical, Tox or RS) Signed Contract YES NO Did process scale? Comparable to confirmation run(s)? Technology Transfer Existing Process Scale-Up into Manufacturing Limited Process Robust, consistent, predictable and scalable process? Development Plan Confirm Lab-Scale Process (Final Confirmation) Create Batch Records NO Establish ‘corralling a project’ as a company foundation. Build client relationship management, contract templates and scope of work templates to allow every project to be corralled systematically. Evaluate the organizational structure to segregate lab from manufacturing function Design the Project Team as ultimate authority and empower for delivery

6. Remember PDCA! Plan Take time planning changes to the how the business operates Do Enact the changes according to an established plan Check Internal and external feedback Success statistics Act Make adjustments based on feedback and statistics Consider client feedback an impartial mirror, adjust accordingly www.bioprocessingalliance.com - Confidential -

7. How Can We Help You? Development and clinical manufacturing expertise Multi-disciplined track record Extensive experience in Contract Manufacturing www.bioprocessingalliance.com

8. Bio-Processing Alliance Inc. Email:info@bioprocessingalliance.com(001) 289-878-5969 Thank you for your time...please contact us for further information! www.bioprocessingalliance.com