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ISPE Good Practice Guide: Technology Transfer (Third Edition) cover image

ISPE Good Practice Guide: Technology Transfer (Third Edition)

Published:December 2018

Pages:152

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.

This Guide presents industry good practices for successful and efficient execution of technology transfer projects. It intends to achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations.

This Guide is intended to be used as a generic guide to technology transfer between two parties for any applicable transfers in the product lifecycle. This Guide provides information and tools for its practical application, under three main topics:

  • Technology transfer of analytical methods
  • Technology transfer of drug substance (Active Pharmaceutical Ingredients (APIs))
  • Technology transfer of drug product (dosage forms manufacturing processes)

This third edition of the ISPE Good Practice Guide: Technology Transfer, highlights the following:

  • Alignment with science and risk-based (Quality by Design (QbD)) principles described in ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System, and ICH Q11 Development and Manufacture of Drug Substance, including reference to Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), material attributes, design space (where used) and, in particular, Control Strategy
  • Alignment with the process validation concepts and life cycle approach as described in, for example, FDA Process Validation Guidance, Jan 2011
  • Recognition that knowledge management is a critical component of effective technology transfer.
  • Industry developments and potential regulatory impacts
  • Recognition that having a robust quality culture, for both the sending and receiving units, is important for ensuring successful technology transfer
  • Addition of redacted case studies as examples

  • 1 Introduction
  • 1.1 Background and Purpose
  • 1.2 Rationale for this Third Edition
  • 1.2.1 ICH Q10 Pharmaceutical Quality System [1] and Technology Transfer
  • 1.2.2 Product Lifecycle
  • 1.2.3 Intellectual Property and Confidentiality Agreements
  • 1.2.4 Quality Agreements
  • 1.2.5 Science and Risk-Based Approaches and Control Strategy
  • 1.2.6 Quality Risk Management
  • 1.2.7 Communication
  • 1.3 Scope
  • 1.4 Key Terms
  • 2 Technology Transfer - Planning Considerations and Success Criteria
  • 2.1 Introduction
  • 2.2 Technology Transfer Planning Considerations
  • 2.2.1 Developing an Early Agreement Between the Sending and Receiving Units
  • 2.2.2 Sending Unit and Receiving Unit Working Closely
  • 2.2.3 Clear Understanding of Roles and Responsibilities for Both the Sending and Receiving Units
  • 2.2.4 Effective Knowledge Transfer
  • 2.2.5 Information Package
  • 2.2.6 Quality Risk Management
  • 2.2.7 Phases and Stage Gate Approach
  • 2.3 Technology Transfer Success Criteria
  • 3 Technology Transfer Project Phases
  • 3.1 Form Transfer Team and Develop Charter
  • 3.1.1 Establishing a Team
  • 3.1.2 Developing a Charter
  • 3.2 Consolidate Knowledge for Transfer and Develop Technology Transfer Proposal
  • 3.2.1 Technology Transfer Proposal
  • 3.2.2 Technology Transfer Package
  • 3.3 Identify Risks, Conduct Risk Assessments, and Develop Technology Transfer Plan
  • 3.3.1 Identifying Risks
  • 3.3.2 Risk Analysis and Evaluation
  • 3.3.3 Technology Transfer Plan
  • 3.4 Operational Readiness
  • 3.5 Process (Procedure) Qualification3.6 Finalize Transfer and Perform Review
  • 3.6.1 Planning for Transition of Support and Disengagement of Sending Unit
  • 3.6.2 Support of Regulatory Activities
  • 3.6.3 Lessons Learned
  • 4 Technology Transfer of Analytical Methods
  • 4.1 Introduction
  • 4.2 Technology Transfer Process
  • 4.2.1 Form an Analytical Method Transfer Team
  • 4.2.2 Consolidate Knowledge for the Analytical Method Transfer
  • 4.2.3 Identify Risks by Conducting Risk Assessments
  • 4.2.4 Readiness to Ensure Receiving Unit “Right the First Time” Execution
  • 4.2.5 Analytical Method Transfer Plan
  • 4.2.6 Analytical Method Transfer Protocol
  • 4.2.7 Execute the Analytical Method Transfer
  • 4.2.8 Analytical Method Transfer Report
  • 4.3 Points to Consider
  • 4.3.1 Site Selection
  • 4.3.2 Governance
  • 4.3.3 Areas to be Aware of for Analytical Method Transfers
  • 4.4 Additional Sources of Information
  • 5 Technology Transfer of Drug Substance
  • 5.1 Introduction
  • 5.2 Technology Transfer Process
  • 5.2.1 Initial Risk/Feasibility Assessment
  • 5.2.2 Consolidate Knowledge for Technology Transfer Package
  • 5.2.3 Technology Transfer Operational Readiness
  • 5.2.4 At Scale Process (Procedure) Evaluation and Qualification
  • 5.2.5 Finalize Transfer and Perform Review
  • 5.3 Points to Consider
  • 5.4 Example Gap Analyses for Small Molecule and Large Molecule Processes
  • 6 Technology Transfer of Drug Product
  • 6.1 Introduction
  • 6.2 Technology Transfer Process
  • 6.2.1 Identify Risks, Conduct Risk Assessments, and Develop Technology Transfer Plan
  • 6.2.2 Consolidate Knowledge for Technology Transfer Package
  • 6.2.3 Technology Transfer Execution/Pilot Scale Batches
  • 6.2.4 Engineering Runs/Pre-Process Qualification Runs
  • 6.2.5 Process (Procedure) Qualification
  • 7 Quality Aspects of Technology Transfer
  • 7.1 Introduction
  • 7.2 Quality Representation on the Technology Transfer Team
  • 7.3 Quality by Design and Control Strategy
  • 7.4 Quality Risk Management
  • 7.5 Analytical Comparability/Similarity and Stability Strategy
  • 7.6 Process Validation/Process Performance Qualification Strategy
  • 7.7 Change Management
  • 7.8 Execution
  • 8 Appendix 1 - Checklist of Information/Documents for Large and Small Molecule Technology Transfer
  • 9 Appendix 2 - Case Studies: Biologics
  • 9.1 Summary
  • 9.2 Main Challenges
  • 9.3 Overview of Technology Transfer Phases
  • 9.3.1 CMO Selection
  • 9.3.2 Project Initiation
  • 9.3.3 Project Execution
  • 9.4 Risk Management
  • 9.5 Technology Transfer Case Studies
  • 9.5.1 Biologics Case Study #1: Transfer of a Phase 2 mAb Drug Substance with Significant Clinical Potential
  • 9.5.2 Biologics Case Study #2: Transfer of a Late Clinical Phase mAb from One CMO to Another CMO in Preparation for PPQ and Future Commercial Manufacture
  • 9.5.3 Biologics Case Study #3: Transfer to a CMO for Evaluation at Laboratory Scale, Prior to Transfer to Pilot and GMP Scale
  • 9.5.4 Biologics Case Study #4: Transfer to CMO for Evaluation at Laboratory Scale, Prior to Transfer to non-GMP Pilot Scale
  • 9.5.5 Biologics Case Study #5: Transfer Involving a Small Biotechnology Company who Owned the Product (Fusion Protein), from One CMO (Early Clinical Phase) to Another CMO for Scale-up and Commercialization
  • 9.6 Conclusions/Lessons Learned
  • 10 Appendix 3 - Case Studies: Small Molecule
  • 10.1 Summary
  • 10.2 Main Challenges
  • 10.3 Technology Transfer Process
  • 10.4 Technology Transfer Case Studies
  • 10.4.1 Small Molecule Case Study #1: Supply Chain Driven Technology Transfer
  • 10.4.2 Small Molecule Case Study #2: Alignment of Quality Management Requirements for Method Transfer
  • 10.4.3 Small Molecule Case Study #3: Development to Commercial at a CDMO
  • 11 Appendix 4 - Engineering Considerations for Technology Transfer
  • 11.1 Introduction
  • 11.2 Examples
  • 11.3 Lessons Learned
  • 11.3.1 Useful Techniques for Capturing Engineering Information
  • 12 Appendix 5 - Example of a Failure Mode and Effect Analysis (FMEA) for a Non-Sterile Drug Product
  • 13 Appendix 6 - Example of Information that May be Included in Technology Transfer Report
  • 14 Appendix 7 - References
  • 15 Appendix 8 - Glossary
  • 15.1 Acronyms and Abbreviations
  • 15.2 Definitions
  • Suzanne Aldington, Lonza, United Kingdom
  • Mervin H. (Vinny) Browning III, MS, Amgen Inc., USA
  • Jose A. Caraballo, Bayer U.S., USA
  • Mike Cohen, Pfizer Inc., USA
  • Bruce Davis (Co-Lead), Global Consulting, United Kingdom
  • Beth Haas, CAI, USA
  • John Herberger (Co-Lead), Amgen Inc., USA
  • Corinne Kikegawa, Amgen Inc., USA
  • Maurice Parlane, New Wayz Consulting Ltd./CBE Pty Ltd., New Zealand
  • Ruchi Thombre, Pfizer Inc., USA
  • Noreen Troccoli, Sanofi, USA
  • Maria Vazquez-Rey, Lonza Biologics Porriño, Spain
  • Nick Vrolijk, Celldex Therapeutics Inc., USA

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated. This third edition of the ISPE Good Practice Guide: Technology Transfer was developed by an international team of authors from across the industry. This Guide presents a general approach and good practices for effective technology transfer with redacted case studies as examples. The intent is for the reader to utilize Chapters 1, 2, and 3 as a foundation and the subsequent chapters as applicable. The reader is encouraged to utilize the various lists, tables, figures, and templates for illustrative purposes.