ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
2-Day Training Event at the European Aseptic and Sterile Environment
5 - 6 NOV 2024 | (EASE) Facility Strasbourg, France
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.
What to Expect?
Overview of EASE Facility
Strasbourg, France
Training
Biopharmaceutical Manufacturing Facilities and Processes Training - Days 1 and 2
ISPE and the European Aseptic and Sterile Environment Training Center (EASE) have partnered to bring an immersive training experience to participants. The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers.
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.
The initial segment of the training will concentrate on regulations and facility design, including a tour of the facility and hands-on experience in a clean room to comprehend the design principles integrating ball rooms and enclosed processes, reflecting current industry trends.
The subsequent portion of the training will focus on biotech processes, with participants spending time in clean rooms to recognize process equipment and, where feasible, engage in certain operations. Additionally, proposed downstream operations such as chromatography, harvesting, and UFF will be explored during this phase.
- 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 or stainless steel equipment in biomanufacturing
- Strengthen the operational relationship between product, process, and facility
- Apply regulatory guidance impacting process development, execution and facilities
- Practical aspects of Biopharmaceutical Manufacturing operations
- Introduction
- Biotech Basics
- Regulatory & QbD
- Culture of Cells & Media
- Filtration processes
- Viral Removal and Inactivation
- Chromatography
- Single-use
- Facility and Utilities
- Scale-up
- Pre-Course work materials
- Interactive exercises
- Learning Assessments
- ISPE Guide: Biopharmaceutical Process Development and Manufacturing
Daily Schedule at a Glance
Training course times are listed in Central European Time (CET). 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 - 1300 | Lunch |
| 1300 - 1430 | Course Content & Exercise |
| 1430 - 1445 | Break |
| 1445 - 1615 | Course Content & Exercise |
| 1615 - 1630 | Wrap-up, Questions, Discussion |
| 0830 – 0845 | Login |
| 0845 - 0900 | Recap |
| 0900 - 1030 | Course Content & Exercise |
| 1030 - 1045 | Break |
| 1045 - 1215 | Course Content & Exercise |
| 1215 - 1300 | Lunch |
| 1300 - 1430 | Course Content & Exercise |
| 1430 - 1445 | Break |
| 1445 - 1615 | Course Content & Exercise |
| 1615 - 1630 | Wrap-up, Questions, Discussion |
Who should attend this 2-Day hands-on training event?
- 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
Communities of Practice
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice.
Pricing
| Early Registration *Ends 10 Jun 2024 | Regular Registration | |
|---|---|---|
| Member | $1,585.00 | $1,885.00 |
| Non Member | $1,885.00 | $2,185.00 |
| Government | $800.00 | $800.00 |
| Student | $500.00 | $500.00 |
All prices exclude VAT at 20%
EASE Training Facility
EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU
Production & QC area upstream
Production & QC area upstream 2
Production area for sterile liquids
Production area for dry forms
Air treatment system