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 Profile:

Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd

Len has over 30 years of experience in both industry and academia. Len has been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. He is a member of a Regulatory working group, the ISPE and BIA

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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.

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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

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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:
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DAY 1:
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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

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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

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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
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Summary:

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

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