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.
Daily Schedule and Pricing
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Online Live5 - 8 Dec 2022Daily Schedule at a Glance
Training course times are listed in Eastern Standard Time (ET). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
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Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.