BARDA/USU Influenza Vaccine Manufacturing Training

Program

Center for Integrated BioSystems

Utah State UniversityKamal Rashid and Bart Tarbet

Center for Integrated BioSystems

http://www.biosystems.usu.edu/

Experience in Workforce Development

The Institute is comprised of a recognized team of scientists,

who work together on research oriented toward the control of

viral diseases:

•Formed over 20 years ago to conduct pre-clinical testing of

antivirals for therapeutic activity.

•In 2010, the Institute received NIH funding to investigate novel

influenza virus vaccines.

Institute for Antiviral Research

• http://www.usu.edu/iar/

Institute for Antiviral Research

http://www.usu.edu/iar

Flow Chart of Training Course Activities

Cell Based

Vaccine

• Set up and follow through purification using Roller Bottles

Upstream and

Downstream

• Vaccine production in bioreactors

• Single use bioreactors

• Anion exchange chromatography

• Purification Strategies,

• cGMP and Validation Issues

Upstream and

Downstream

• Inoculation and harvest

• Clarification and inactivation

• Concentration and zonal ultracentrifugation,

• Detergent splitting and ultrafiltration

• cGMP and Validation Issues

Egg Based

Vaccine

• Set up and follow through purification using embryonated eggs

Up-Stream Processing

Participants follow SOPs to perform the growth and the

infection of cells/eggs

Tasks include:

�Cell line preparation Egg handling

�Media preparation Virus injection

�Bioreactor set-up Incubation

�Growth parameters Harvest

�Monitor and control Waste disposal

�Harvest & Waste Disposal

Cell Culture & Scale-Up

• Cell culture technology (both animal & microbial)

– From a frozen stock to a bioreactor

• Scale-up Strategies:

Roller Bottles

Microcarrier Cell Culture

Hollow Fiber Cell Culture

Stirred-Tank Bioreactors

Single-use Bioreactors

Vaccine production in fermenters:

• recombinant microorganisms

Critical Issues in Vaccine Production

– Optimizing virus replication

– Bulk harvest:

• Clarification/Separation/Concentration

– Centrifugation including zonal ultracentrifugation

– Chromatography

– Ultrafiltration

• Virus inactivation

• Detergent “splitting”

– Purification

• Possible contaminants

– Blending/formulation of final product:

• Adjuvants

– Final Product Testing

• Potency

• Stability

• Sterility

Critical Issues in Vaccine Production

cGMP and Validation

• Good manufacturing Practice

• Process Validation

• Change Control

• Facility and utility consideration for manufacturing

operation

• Preparation of SOP to clean a media preparation

tank: Practical session

• Cleaning and cleaning validation issues

• Risk based compliance

• Deviation reporting and investigation

• Preparation of validation protocols: Practical session

BARDA / USU Influenza Vaccine Biomanufacturing Training ProgramFebruary 21 – March 11, 2011

Utah State University, Logan, Utah

Participating Countries: Egypt, Korea, Romania, Russia, Serbia,

Thailand & Vietnam

Up-coming Training Course:

April 23-May 11, 2012

18 scientists from the following countries

are registered to attend the 2nd Annual

BARDA/USU Vaccine Manufacturing

Training Program:

Egypt Indonesia Kazakhstan

South Africa Vietnam

The program schedule is the same as last

year with improvements based on feed-

back evaluations.

Our Team

Dr. Kamal Rashid

Dr. Bart Tarbet

Dr. Giovanni Rompato

Dr. Tim Taylor

Dr. Craig May

Dr. James Dorward

Dr. Afifa Sabir

Patti Champine

Shaun Barnett

Taylor Hatton

Jason Brown

Brett Hurst

Grant Program Officer: Chuong Huynh

( BARDA)

Dr. Julia Cino

Dr. Peter Moore

Dr. Jamal Amer

Corey Card

Tommy Smith

Chris Heck

Kris Borecki

Jeannine Huenemann

Ken Olsen

Darlene Orduno

Therese Tarbet

Thank You

Questions ?

For more information please contact:

Dr. Kamal Rashid kamal.rashid@usu.edu

www.biosystems.usu.edu