Biopharmaceuticals: CMC Aspects Training Course (T67)
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
Daily Schedule and Pricing
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Online Live10 - 13 Mar 2025Daily 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
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
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.