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BTEC’s International
Influenza Vaccine Manufacturing
Training Program –
Challenges and Lessons Learned
Dr. Ruben Carbonell
BTEC Director
November 2011
BTEC’s unique niche • High-quality hands-on education
• Educate and place students in
workforce
• Professional development courses
• Process development and analytical services
2
• NC State University’s Centennial Campus
• 82,500 ft2 (7,665 m2) labs, classrooms,
offices
• $15 million (USD) in cGMP equipment
• 3 scales of operation:
bench (2 L), intermediate (30 L), and pilot (300 L)
Facility highlights
Country Institution #
Egypt Vacsera 3
India Serum Institute
of India
2
Indonesia Biofarma 4
Korea Green Cross 1
Mexico Birmex 3
Romania Cantacuzino
Institute
4
Russia IEM 3
Serbia Torlak Institute 3
Thailand GPO
Thai FDA
5
2
Vietnam IVAC 5
Fundamentals of cGMP Influenza Vaccine Manufacturing (BARDA)
Countries/institutions participating in 2011
Tools created for the program
4
Tool Purpose Notes
Registration
system
Gather participant
information
• Online form connected
to database
Course
Assessment Tool
(CAT)
Measure overall
learning during
training
• Identical pretest/post-
test before & after course
• Computer-based
• 2 hours allowed to submit
End-of-module
quizzes
Measure participants’
mastery of content
30 minutes allowed to
complete
End-of-course
evaluation
Gather feedback on
content, instruction, &
program logistics
20 minutes allowed to
complete
Follow-up survey Gauge transfer of
learning to the
workplace
• Administered 8 weeks
after course ended
• 13 questions
Instructional strategies
• Direct instruction by
subject matter experts
• Presentation of both
egg- and cell-based
production approaches
• Hands-on laboratory
exercises (43 hours total)
• 3 weeks, 5 days/week,
8 hours/day (120 hours)
5
Instructional strategies (continued)
• Short seminars
– Use of disposable equipment by Sartorius Stedim
– Novartis’s response to 2009 pandemic
• Tours of local vaccine manufacturing facilities
(Novartis and Pfizer, 8 hours total)
6 © Novartis AG
Generalized influenza vaccine process
Upstream
processing
Downstream
processing
Formulation
Fill / Finish
Final
characterization
Release
Eggs
Cells
LAIV
Whole virus
Subunit
Split
Centrifugation
Chromatography
UF / DF
7
Course content
Modules (Total Hours) Activities and labs (Hours)
1. Introduction (4) Not applicable
2. Regulatory / Quality Systems (12)
EMA, FDA, ICH, cGMP
Guidelines review (3)
3. Aseptic Practices (8)
Contamination mitigation, monitoring, control
Evaluation of BTEC practices (2)
4. Facilities and utilities (8)
Process flows, HVAC
BTEC tour and evaluation (2)
5. Upstream processing (32)
Egg- and cell-, single and multi-use
technology
CIP/SIP, cell banking, growth
kinetics (16)
6. Downstream processing (32)
Centrifugation, chromatography, UF/DF
Monolith vs column
chromatography (18)
7. Analytical (24)
HCP, DNA, endotoxin, bioburden
NA, HA, SRID, SDS-PAGE (14)
Course total = 120 hours 8
Challenges and keys to success
Challenges Solutions
Conducting a
large project within
limited time frame
Use a project
management approach
Training a
heterogeneous
group
• Present fundamental
principles and
practices
• Provide opportunities
for hands-on training
• Encourage peer
learning
• React quickly to
feedback
9
Challenges and keys to success
Challenges Solutions
Recruiting and
ensuring logistical
support for a
heterogeneous
group
Partner with NC State’s
Global Training Initiative
(GTI)
Provide an
industry-relevant
course with
significant
hands-on training
in a safe manner
• Create a team of
subject matter
experts
• Develop a
generalized process
for influenza vaccine
production
• Utilize cell- and egg-
based technologies
Lessons learned • Language barriers
– Use clear, simple language in instruction, quizzes
– Maximize hands-on activities; limit lecture
• Heterogeneous group
– Assess participants’ competencies prior to their arrival
– Implement pre-arrival survey
– Adjust instruction accordingly
• Safety concerns
– Use models instead of actual influenza virus in
some modules
• Live viruses should be used in next round
– Novartis cell line
11
The 2012 program • Emphasize process
development, scale up and
validation
• Create 2 new courses
– Advanced Upstream
Processes for Influenza
Vaccine Manufacturing
– Advanced Downstream
Processes for Influenza
Vaccine Manufacturing
– June 2012: back-to-back
course offerings
12
• Develop an in-house, cell-based,
industrially representative,
influenza vaccine production process
• Continue
offering the
Fundamentals
of cGMP
Influenza
Vaccine
Manufacturing
course
• Extend the project by
investigating institutions’
training needs
– March workshop at BTEC
– Visits to some facilities
13
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