ISPE Hands-On Controlled Production of Drug Substance and Drug Product in Biomanufacturing
2-Day Training Event
13 - 14 October 2025 | Biomanufacturing Training and Education Center | Raleigh, NC
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Centennial Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges.
What to Expect?
Overview of BTEC Facility
Raleigh, NC
Training
Controlled Production of Drug Substance and Drug Product in Biomanufacturing Days 1 and 2
“Manufacturing in a state of control.” Sounds simple. However, the reality facing companies that produce products via the ever-changing platforms in biomanufacturing where product protection, safety, and efficacy are the foundation principles. Production operations must adhere to the “business model” of the manufacturing enterprise while not running afoul of the vast global network of regulatory agencies, often not in complete harmonization as ICH would lead us to believe.
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges. The operational resources of BTEC will provide support as the thought leadership of ISPE’s extensive biomanufacturing curriculum and their Baseline and Good Practice Guides provide a roadmap to understanding and achieving the “state of control” that represents success.
Objectives:
- Understanding how “state of control” can be defined and achieved through different design and development decisions
- Identification of the product-process-facility paradigm being essential to the ability to optimize manufacturing under current Good Manufacturing Practice
- The application of good aseptic practice as the foundation to achieving safety and efficacy goals
- Apply current Industry lessons learned to achieve improved operational efficiency
Who should attend this 2-Day hands-on training event?
- Architects, Engineers, and Managers that have responsibility for the development and execution of compliant facility solutions to meet global regulatory guidance.
- Quality Assurance and Regulatory Specialists, Validation Specialists, Manufacturing Supervisors, and Technical Support Personnel engaged in the manufacture of consumer goods where safety and efficacy are key decision drivers
- Suppliers and Vendors whose products and services must align with the overall needs of a compliant Manufacturing Enterprise focused on patient safety and product compliance
Communities of Practice
- Biotechnology
- ATMPs
- Sterile Products
- Single use
- CQV
- Project Management
- Utilities
- Pharma 4.0
- Sustainable Facilities
- Product/Process Development
- Biotechnology
- ATMPs
- Sterile Products
- Single use
- CQV
- Project Management
- Utilities
- Pharma 4.0
- Sustainable Facilities
- Product/Process Development
Pricing
| Early Registration *Ends 13 Sept 2025 | Regular Registration | |
|---|---|---|
| Member | $2,700.00 | $3,000.00 |
| Non Member | $3,000.00 | $3,300.00 |
| Government | $1,200.00 | $1,200.00 |
| Student | $750.00 | $750.00 |
| Affiliate | $2,000.00 | $2,000.00 |
BTEC Training Facility
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