Online Lyophilization Short Course

Building on existing content from LyoHUB’s “Lyo101” course, currently delivered in an in-person format, this NIIMBL project will create eight online learning modules.
Categories
Incumbent worker training

Industry Need

  • As part of a two-year technology roadmapping process, the Advanced Lyophilization Technology Consortium (LyoHUB) identified an unmet need for online educational programs in pharmaceutical lyophilization. 

Approach

Building on existing content from LyoHUB’s “Lyo101” in-person course, this project created eight online learning modules, together with assessment tools and instructions for a virtual laboratory exercise, to meet the existing industry need.  


The new online course blends voice-over PowerPoint presentations, video recordings of lecturers and of lyophilization equipment, and machine graded assessments. The course was beta-tested by LyoHUB members to finalize and improve the course before its release. Module topics include: 

  1. Introduction to Pharmaceutical Lyophilizatio (Dr. Elizabeth Topp, Purdue University)  
  2. Overview of the Lyophilization Process (Dr. Arnab Ganguly, IMA Life)  
  3. Production Lyophilizers (Dr. Alina Alexeenko, Purdue University)   
  4. Glass Transition Temperature (Tg, Tg1) (Dr. Akhilesh Bhambani, Merck and Co.) 
  5. Freezing, Presented (Dr. Greg Sacha, Baxter) 
  6. Primary and Secondary Drying (Dr. Ehab Moussa, AbbVie) 
  7. Graphical Design Space (Dr. Steve Nail, Baxter) 
  8. Quality Attributes of Lyophilized Products (Dr. Akhilesh Bhambani, Merck and Co 

The program is intended for operators, scientists, and engineers with limited lyophilization experience. In addition, some components of the program will be accessible to non-technical personnel. 

Impacts

Course will feature video recordings by leading experts in lyophilization and be posted in open-access form on the pharmaHUB website.

The goal is to address an unmet need in online educational programs for workforce training in lyophilization.

Online course in pharmaceutical lyophilization including eight online learning modules, virtual laboratory exercise and assessment.

Final 8-module course, featuring video recordings by leading experts in lyophilization, a virtual laboratory exercise and an assessment, fulfills an unmet need in online educational programs for workforce training in pharmaceutical lyophilization.

The online modules have been posted in open-access form on the pharmaHUB website.

Contributes to NIIMBL’s goal of educating and training a world-leading workforce in biopharmaceutical manufacturing 

Value Statement/Outcomes

Financial benefit to the industry is anticipated in the form of shorter times to implement new lyophilization processes and reduced lyophilizer downtime. The typical cost of production lyophilizer usage is $300,000 per week. The estimated time to impact the industry is 6-9 months, the duration of this project and the time needed to test and deploy the modules.

Outputs/Deliverables

Eight video modules covering key lyophilization topics (e.g., process overview, freezing, drying, quality attributes, glass transition temperature).

Virtual laboratory exercise recorded at Purdue’s LyoHUB Demonstration Facility, enabling hands-on learning in a digital format.

Integrated assessment tools for each module to evaluate learner performance and ensure content quality.

Course hosted on PharmaHUB as open-access, ensuring broad reach and long-term value for NIIMBL members and the biopharma industry.

Presentations

Online Lyophilization Short Course (PC2.1-002), NIIMBL Member Forum, Virtual, January 23, 2020.

Topp, E. M. & Gray, J., Lyophilization Online Course, LyoHUB Annual Meeting, Rosemont, IL, April 10, 2019.

Topp, E. M., & Gray, J., Lyophilization Online Course, NIIMBL National Meeting, Washington, DC, June 28, 2019.

Additional Project Information (Members Only)

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Project Lead

Purdue University

Purdue University

Participating Organizations

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

North Carolina State University

North Carolina State University