Biopharmaceuticals: CMC Aspects
Biopharmaceuticals: CMC Aspects Training Course
Overview
This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.
What You Will Learn
- Overview of Biopharmaceutical Development
- Quality by Design
- Cell Line and Upstream Development
- Downstream Development
- Analytical Development
- Formulation and Stability
- Drug Product
- cGMP Manufacturing Life Cycle
- Comparability and Biosimilars
- Cost of Goods: Factors and opportunities to control cost of goods
- Regulatory Acceleration: Opportunities/options that can be deployed to accelerate regulatory approvals & speed to market
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
Course Modules
- Overview of the Biopharmaceutical Development Process
- Quality by Design (QbD)
- Cell Line and Upstream Development
- Downstream Development
- Analytical Development
- Formulation and Stability
- Drug Product
- cGMP Manufacturing Lifecycle
- Comparability and Biosimilars
- Cost of Goods: Factors and Opportunities to Control Cost of Goods
- Regulatory Acceleration: Opportunities/Options that can be Deployed to Accelerate Regulatory Approvals (Speed to Market).
Who Should Attend
- Individuals who want to improve their working knowledge of biopharmaceutical development
- Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on biopharmaceutical manufacturing
- Academic institutions engaged in biopharmaceutical development/manufacturing
- Vendors and suppliers of equipment/systems focused on the global biopharmaceutical launch process
- Industry professionals focused on manufacturing risk assessment/mitigation
- Quality assurance and quality control specialists
- Validation specialists
Additional Course Details
Communities of Practice (COP)
This training course will be of particular interest to:
- Existing members of the Biotechnology CoP
- Future members of the new Advanced Therapy Medicinal Products (ATMPs) CoP
- Existing and future members of the ISPE Process/Product Development CoP