An Overview of Biopharmaceutical Manufacturing Processes (T24) - Updated!
Overview
Having the foundational knowledge of the underlying biopharmaceutical science is critical for developing viable biopharmaceutical processes for the clinical and commercial manufacturing of biotechnology products. Explore commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
What You Will Learn
- Develop biopharmaceutical processes for clinical and commercial manufacturing of biotechnology products
- Identify key operating parameters for each bioprocess unit operation
- Decide between available options for single-use technologies in biomanufacturing
- Strengthen the operational relationship between product, process, and facility attributes
- Apply regulatory guidance impacting process development and execution
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- ISPE Guide: Biopharmaceutical Process Development and Manufacturing
Online Live Course Modules
- Introduction
- Biotech Basics
- Regulatory & QbD
- Culture of Cells & Media
- Filtration processes
- Viral Removal and Inactivation
- Chromatography
- Single-use
- Facility and Utilities
- Scale-up
Who Should Attend
- Individuals with a working knowledge of basic biotechnology and GMP principles, responsible for process design, process validation, and equipment design/selection for biopharmaceutical applications
- Management, supervisory, and engineering personnel beginning work in biopharmaceutical product development, production operations, quality assurance, and regulatory compliance
- Anyone who wants to know how biopharmaceutical manufacturing processes work
Online Live Course Additional Details
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography. Course topics include:
Biotechnology basics
- Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
- What parameters are important for process validation
- Critical factors for developing a viable commercial manufacturing process
- The attributes of a "good biotech process" for successful manufacturing
- Process/Facility relationships
- The impact of single-use systems in bioprocesses
Additional content will focus on a review of current regulatory guidance impacting process development and execution.
Communities of Practice
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice.