CMC Masterclass - Advanced Training in Biopharmaceutical Manufacturing

Introduction:

This CMC Masterclass offers an immersive exploration into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) for biopharmaceuticals. This comprehensive program covers the full spectrum of biologics; from monoclonal antibodies to advanced therapies like nucleic acids and viral vectors as well as cell therapies. Through a blend of theoretical learning, regulatory insights, and practical examples, participants will gain the expertise needed to navigate the complexities of CMC workflows, optimise manufacturing processes, and ensure regulatory compliance. Led by an industry expert, this masterclass promises to equip professionals with the knowledge and skills to excel in the dynamic field of biopharmaceutical manufacturing. This masterclass promises to deliver unparalleled insights and practical strategies for mastering CMC challenges in biopharmaceutical manufacturing.

‍

Methodology:

The course employs a mix of lectures, case studies, and Q&A sessions to foster active engagement and enhance learning outcomes. A seasoned professional with extensive experience in CMC and regulatory interactions will deliver the content, providing valuable insights and practical guidance.

‍

Key Outcomes:

Upon completion of the course, participants will:

• Gain a deep understanding of CMC workflows and best practices for biopharmaceutical manufacturing.
• Acquire insights into regulatory guidelines from FDA and EMA governing biologics and ATMP manufacturing.
• Learn strategies for successful filing submissions, comparability assessments, and control measures.
• Develop proficiency in managing change controls, ensuring product quality, and maintaining process robustness.
• Enhance interdisciplinary collaboration and communication skills essential for CMC projects.

‍

Who Should Attend?

This masterclass is tailored for professionals involved in biopharmaceutical manufacturing with interests around the CMC discipline and operational excellence, including but not limited to:

• Process Development Scientists
• Manufacturing Engineers
• Quality Assurance/Quality Control Specialists
• Regulatory Affairs Professionals
• Project Managers
• Technology Transfer Specialists
• Professionals in Advanced Therapy Medicinal Products (ATMPs) manufacturing

‍

Schedule:
‍

DAY 1:
‍

Session 1: 14:00 - 16:00 UK Time (09:00 AM- 11:00 AM US EST time)

Overview of Biopharmaceutical Manufacturing and Regulatory Landscape
Introduction to biopharmaceutical manufacturing processes
Regulatory landscape: FDA and EMA guidelines
Key considerations for compliance and quality assurance in CMC
‍

Session 2: 16:15 - 18:00 UK Time (11:15 AM -  1:00 PM US EST time)

Mastering mAbs: Manufacturing Processes and Regulatory Compliance
Overview of mAbs manufacturing workflows
Critical quality attributes and control strategies
Regulatory requirements for mAbs production and filing submissions