Table of Contents
Chapter 1: Introduction
Chapter 2: What Is Bio-Outsourcing?
- Introduction
- Biomanufacturing Overview
- Analysis of the Bio-Outsourcing Industry
- References
Chapter 3: Is Bio-Outsourcing Right for Your Company?
- Factors to Consider When Outsourcing Biomanufacturing
- Financial Considerations
- Business Factors
- Phase of Clinical Development and Regulatory Concerns
- Product Market Size
- Potential Drawbacks of Bio-Outsourcing
- References
Chapter 4: Finding and Choosing the "Right" CBMO
- CBMO Selection Criteria
- Stage of Manufacturing and Product Pipeline Considerations
- Type of Product
- Commitment to Quality
- Availability and Training of Personnel
- Financial History and Stability
- CBMO Selection Process
- Preparation of Request for Proposals
- Sponsor Project Team Audits
- Making the Final Decision
- References
Chapter 5: Negotiating and Crafting the Quality Agreement
- Drafting a Term Sheet
- Overview of the Quality Agreement
- Essential Components of the Quality Agreement
- Scope of Services and Business Terms
- Change Control Provisions
- Fee Structures, Pricing, and Payment
- Audit Rights of the Sponsor
- Manufacturing Schedules
- Termination/Exit Provisions
- Indemnification and Liability Insurance Terms
- Subcontracting and Assignment of Manufacturing Rights
- Confidentiality and Intellectual Property Rights
- Regulatory Compliance Provisions
- Dispute Resolution Provisions
- Crafting the Agreement and Periodic Reviews
- Joint Service Agreements
- Signing the Agreement and Closing the Deal
- References
Chapter 6: Best Practices for Bio-Outsourcing Relationships
- Overview of Best Practices
- Process Management Best Practices
- Technology Transfer
- Process design plan
- Assignment of Responsibility When Things Go Wrong
- Availability and Training of Personnel
- Best Practices for Organizational Structure
- Governance and Relationship Management
- Project Team Assembly and Structure
- Role of the "Man in the Plant"
- Best Practices for Performance Assessment
- Importance of Performance Metrics
- Assessing Regulatory Compliance
- Regulatory Inspections
- Sponsor Audits of Contractor Facilities
- Information Systems
- Overview
- Data Management and Electronic Record Security
- References
Chapter 7: Future of Bio-Outsourcing: Impact of New Technologies and Emerging
Markets
- General Considerations
- Impact of Expression Systems and Process Improvements
- Advent of Disposable Technologies
- Emergence of Lower Cost CBMOs
- Follow-On Biologics and Resurgence of the Vaccine Market
- References
Chapter 8: CBMO Resource Guide and Directory
- Distribution of CBMO Services
- CBMO Manufacturing Capabilities
- CBMO Directory of Services
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