American Vaccine

Resources: Gate 1
Objectives

Our goal is to produce the vaccine as cost-effectively as

possible
Maximizing ROI will prioritized over strictly the cheapest
alternatives

Goal production rate, pending vessel considerations:

7.5M
Demand

Flu Vaccines
160

140

120
Doses (Millions)

100
Distributed
80
Produced
60

40

20

0
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Year
Upstream Considerations

Media Prep Buffer Prep

Production Downstream
Seed Train
Bioreactor Processes
Comments

Seed Train-Various market options

Varying amounts of disposability
Compatibility and sizing concerns
Disposable Reactors likely to be cheaper
Proof of concept
Remaining Questions

Substrate acquiring, preparation and properties

Proprietary vs. Commercially available media
Some heuristics were put into consideration for the recovery and purification process

The most impurities were removed first

The easiest impurities were removed first
The most difficult and expensive separations last.
Processes that make use of the greatest differences in
the properties of the product and its impurities were
selected.
Processes that exploit different separation driving
forces were selected.
Reference:
http://whvvugt.home.xs4all.nl/DrugDesign/BioprocessD
esign.pdf
 Primary Inactivation Capture and
Recovery Purify
Virus
1. Centrifugation Inactivation/Filtration Chromatography:
:
2. Filtration 1. Solvent/Detergent 1. Size exclusion
Inactivation chromatography
2. Virus filtration

Disk bowl centrifuge, it S/D is the most widely

gives better solid liquid used method,
separation and liquid- Detergent affects only
liquid separation. lipids and lipid
Closed design, prevents derivatives
contamination of products Simple and easy to use.
and environment. Easy to
operate.
 Vaccine
Purified product Concentrated and ready to be
stabilized product shipped

Concentrating &
Storage of Final Formulation
Stabilizing
Product (Out of Scope)
Material

Example: TFF
Typical capital costs
Tangencial Flow Freeze-drying
include: membrane
Filtration (TFF) Crystallization
holders, plant floor
Other ways
Stability of the Product space requirements,
Microfiltration
Cost utilities, pumps,
Ultrafiltration
valves,
Virus Filtration
instrumentation,
Nanofiltration
piping, tanks, and
Reverse Osmosis
process automation.
Comparing alternatives: Cost
Thank you for your attention!
Objective Statement

American Vaccine Resources is venturing into this

technology to provide proof of concept before moving other
vaccine production to these cells on a large scale. With this in
mind, the goal is to produce the vaccine with cost in mind. I
hesitate to use the phrase as cheaply as possible because
return on investment (ROI) is essentially a secondary objective.
The ultimate goal is to minimize cost, but in the event that a
slightly more expensive alternative leads to substantial returns,
this ROI will become a deciding factor. For this proof of
concept project it is important recognize that this technology
is not yet ready to dominate the market. Based on a demand
for 150 millions vaccines during the upcoming season, we will
aim to produce ~5% of the need which is in the region of 7.5
million doses. The target production rate is subject to
reexamination based on available vessel sizes.