Bioprocess Online Training using Digital Twin (BOT-DT)

Team to use HakoBio platform to build a Digital Twin for one upstream operation (rocker bioreactor) and one downstream operation (tangential flow filtration/TFF) as proof-of-concept.
Categories
Talent/ Pipeline development
Project status
100% Completed

Industry Need

The speed of evolution for the biopharmaceutical portfolio continues to increase with new therapeutic modalities and novel manufacturing technologies, creating a training and learning challenge. The US urgently requires engineers and scientists with the multidisciplinary CMC skills required to develop and demonstrate the next generations of biomanufacturing processes. Further, hands-on training in these skills is cost- and time-intensive.

Solution

The implementation of a Digital Twin allows successful scale-up, implementation and operation to satisfy stringent clinical and regulatory requirements, while ensuring appropriate business and cost structures.

Outputs/Deliverables

OUTPUTS

  • The project accomplished two key innovations. First, a comprehensive bioprocessing curriculum was designed, developed, and tailored to workforce needs through a diverse Curriculum Advisory Committee. Second, an accessible online learning platform was created with an immersive digital twin environment enabling autonomous, self-directed learning. 
  • The curriculum covers foundational upstream and downstream concepts from cell culture through purification following industry standards. Assessments directly map to defined learning objectives for skill-based competencies.
  • The online platform combines engaging multimedia learning modules with cutting-edge digital twin simulation using virtual reality. The digital twin environment allows learners to apply knowledge in a realistic setting and build skills through hands-on practice. Key advantages of digital twins include:
    • Always up to date: Virtual equipment reflects the latest configurations
    • Accessible anytime: Available 24/7 for self-directed learning
    • Easily distributed: Centrally hosted and accessible from anywhere
    • Edge case exploration: Failures and risks impossible to replicate physically.
    • Structured learning prompts guide autonomous training, providing interactive standard operating procedures for equipment usage.
    • The ability to intentionally introduce problems and errors builds robust troubleshooting skills.
  •  Additionally, the team formally evaluated the educational approach through an IRB-approved study protocol with 36 students. The beta testing investigation generated an outcomes report to refine the curriculum and platform.
  • This commitment to evidence-based improvement will strengthen follow-on programs that should focus on the connection of the virtual training to the real world, i.e. train students in VR and then assess them on physical equipment for the same tasks.


Impacts

Blended training resources created using video, animation, and virtual reality. These modules will engage students in online courses while providing a simulated hands-on experience.

A HakoBio platform builds a Digital Twin for one upstream operation (rocker bioreactor) and one downstream operation (tangential flow filtration/TFF) as proof-of-concept.

Publications

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Project Lead

Keck Graduate Institute

Keck Graduate Institute

Participating Organizations

California Polytechnic State University

California Polytechnic State University

Catalent Pharma Solutions, LLC

Catalent Pharma Solutions, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

OUAT!

OUAT!

Santa Clara University

Santa Clara University

Sartorius Stedim

Sartorius Stedim