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).
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
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: