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
- Biotech Basics
- Regulatory & QbD
- Culture of Cells & Media
- Filtration processes
- Viral Removal and Inactivation
- Facility and Utilities
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:
- 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.
- Online Live
4 - 5 June
Day 1 0900 – 0915 Login & Registration 0915 - 0930 Introductions 0930 - 1045 Course Content & Exercise 1045 - 1100 Break 1100 - 1215 Course Content & Exercise 1215 - 1245 Lunch 1245 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Questions & Discussions All times for this training course date are displayed in EDT. Day 2 0900 Login 0915 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1145 Course Content & Exercise 1145 - 1200 Questions & Wrap-up All times for this training course date are displayed in EDT.
On or Before 28 May
Member US$1,685 Nonmember US$1,685 Government/Academia US$550 Student US$90
Mail or Fax Registration
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