This white paper provides a comprehensive overview of the challenges and solutions associated with technology transfer for antibody-drug conjugate (ADC) drug product manufacturing.
It covers:
- Outsourcing Trends: Analysis of why ADC developers increasingly rely on contract development and manufacturing organizations (CDMOs) due to high capital requirements and specialized expertise.
- Lonza’s End-to-End Capabilities: Description of support across drug substance and drug product, from early development to large-scale commercial manufacturing.
- Phase-Based Tech Transfer Approach: Details on systematic, holistic strategies emphasizing cross-functional collaboration, robust project management, and clear communication.
- Advanced Containment & Streamlined Processes: Overview of technologies and procedures ensuring operator safety, product quality, and efficient use of valuable ADC materials.
- Risk Assessment & Regulatory Support: Real-world insights into gap analysis, risk mitigation, and regulatory documentation to minimize delays and maximize successful outcomes.
This resource is essential for ADC developers, project managers, and technical teams seeking to optimize tech transfer and manufacturing outcomes in a highly regulated, rapidly evolving field.
Offered Free by: Lonza
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