Advanced Training in Biopharmaceutical Technology Transfer

Introduction:

Technology transfer is a critical process in biopharmaceutical manufacturing, facilitating the transfer of processes, technologies, and knowledge between development and manufacturing sites. A robust technology transfer strategy is essential to ensure seamless transitions, maintain product quality, and accelerate time to market. This advanced training program offers a deep dive into the intricacies of technology transfer, covering key topics such as facility fit, equipment fit, regulatory compliance, risk management, and continuous improvement. Through a combination of theoretical learning and practical application, participants will emerge equipped with the knowledge and skills to excel in technology transfer projects and drive innovation in biopharmaceutical manufacturing.

Trainer Profiles:

Hervé BROLY, PhD

Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.

Mylène TALABARDON, PhD

Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, Sanofi, and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses process development and validation, innovative technologies, process technology transfer and scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.

‍

Methodology

The training program will employ a combination of lectures, case studies, workshops, and interactive discussions to facilitate active learning and engagement. Participants will have ample opportunities to ask questions, share experiences, and apply theoretical concepts to real-world scenarios. The course will be delivered by seasoned industry expert with extensive experience in biopharmaceutical manufacturing and technology transfer.

‍

Key Outcomes

Upon completion of the course, participants will:

• Gain a comprehensive understanding of best practices in the technology transfer process in biopharmaceutical manufacturing
• Gain insights into the regulatory landscape governing technology transfer in biopharmaceutical manufacturing
• Acquire practical insights and strategies for overcoming challenges and ensuring success in technology transfer projects
• Enhance interdisciplinary collaboration and communication skills to facilitate seamless transitions between development and manufacturing sites
• Develop the skills necessary to drive operational excellence and ensure regulatory compliance in technology transfer

‍

Who Should Attend?

This training program is essential for professionals involved in biopharmaceutical manufacturing, including:

• Process Development Scientists
• Manufacturing Engineers
• Quality Assurance/Quality Control Specialists
• Regulatory Affairs Professionals
• Project Managers
• Technology Transfer Specialists
• Cross-functional team members involved in technology transfer projects

Schedule:
‍

DAY 1:
‍

Session 1: Understanding the Landscape of Technology Transfer

14:00 - 15:00 UK Time (9:00 - 10:00 US EST Time) Title: Setting the Stage: Fundamentals of Technology Transfer in Biopharmaceutical Manufacturing

‍

Summary:

• Introduction to technology transfer in the biopharmaceutical industry
• Overview of the regulatory landscape and its impact on technology transfer
• Key considerations for successful technology transfer projects

‍

Session 2: Facility and Equipment Fit for Technology Transfer

15:00 - 16:00 UK Time (10:00 - 11:00 US EST Time) Title: Ensuring Seamless Integration: Facility and Equipment Considerations in Technology Transfer
‍

Summary:

• Assessing facility suitability for new processes
• Equipment qualification and validation in technology transfer
• Mitigating risks associated with facility and equipment changes

‍

16:00 - 16:15 UK (11:00 - 11:15 US EST Time) Time Coffee Break