BioLogistics

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BioLogistics

• What Memphis Offers to The World

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Converging Medical Trends

• Increasing awareness of the advantages of
  personalized medicine designing therapy for an
  individual based on that individuals unique
  characteristics.
• Increasing awareness that biotechnical
  applications offer the optimal or only effective
  treatment of some medical conditions.

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Personalized Medicine

• Therapy developed to maximize an individuals
  unique and inherent ability to eliminate or
  suppress a specific disease process.
• Developing therapy based on molecular genetics.
• Enhancing the inherent capacity of an
  individuals immune system to eliminate or
  suppress disease.
• Enhancing the inherent capacity of an
  individuals cells and tissue to repair
  themselves.
• Biotechnology will be the dominant force in all
  of these markets.

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Expanding Biotech Markets
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Nine Metros Dominate
Seattle
Biotech Leaders
Boston
New York-New Jersey
San Francisco
Philadelphia
Washington-Baltimore
Los Angeles
Research Triangle Park
San Diego
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Potential Of Advanced Cellular Therapies
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Personalized Cellular Therapies

• Require collection of living cells or tissue from
  patients across the US (World).
• Cells or tissue are sent to a central or regional
  site for manipulation and manufacture of
  personalized therapeutic.
• Cellular therapeutic is returned to the patient
  for infusion or implantation.
• All steps are time sensitive.

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Biological Product Shipment

• Many biotech products are composed of living
  cells or tissues whose functional capabilities
  must be preserved to assure effective treatment.
• Must eliminate opportunity for deviation from
  manufacturer-defined and FDA-approved storage
  requirements during transport.
• Minimize time product is out of direct control of
  manufacturer
• Minimize handling
• Minimize shipment time
• No disruption of validated storage environment
• Single carrier for all stages of shipment
  preferred
• Assure continuous traceability and trackability

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Biological Product Shipment

• Northwest Airlines hub (over 200 direct
  flights/day)
• Drop FedEx shipments at 1159 PM for 830 AM next
  day delivery across US and Canada.
• AirNet Express Learjet Gateway for shipment of
  time-critical materials.
• Daily flight to/from Amsterdam for entry to/from
  EU and established agreement with biologics
  re-shipper in EU.
• Shortest in-transit time for product shipment to
  sites in US or Canada.

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Biological Product Manufacturing

• Each facility that manufactures a biological
  product must be inspected and approved by the FDA
  prior to going on line and will be inspected
  annually or biennially thereafter.
• Cost of development of a cGMP compliant
  manufacturing facility can reach 1,000/sq ft.
• Therefore, creation of a single national
  biological product manufacturing site reduces
  costs and regulatory burden.
• Memphis is The Natural Site for a National Site
  because of its biologistical advantages and
  relatively low operating costs.

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Memphis has an overnight shipping hub which is
established and in place, its a centralized
location which will help ensure the efficient
transport of tumor cells and make sure the
vaccine gets back to patients in a timely manner
with a minimum of changing hands. Additional
factors were the attractive real estate market
and the burgeoning biotech market in the Memphis
area. Cell Genesys, Inc. spokesman, quoted
in Memphis Medical News, September 2002
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Leukapheresis Growth
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Mononuclear Cell Customers
Seattle
Portland
Milwaukee
Hackensack
Minneapolis
Pittsburgh
Boston
San Francisco area
Ann Arbor
Denver
Philadelphia
Gaithersburg
St. Louis
Research Triangle
Little Rock
San Diego
Memphis
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Cell Therapy Applications
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Biological devices and therapeutics

• Devices and therapeutics created from living
  materials or composed in part of materials or
  elements derived from living materials.
• Cell-based therapeutics
• Human derived raw materials e.g., cellular
  vaccines
• Non-human derived raw materials e.g., bovine
  hemoglobin based oxygen carrier
• Composite devices using living cells
• Human derived raw materials e.g., skin grafts
  on biological or artificial scaffolding
• Non-human derived raw materials e.g.,
  artificial liver using porcine liver cells in a
  bioreactor.

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Memphis has an overnight shipping hub which is
established and in place, its a centralized
location which will help ensure the efficient
transport of biological materials and make sure
our product gets back to patients in a timely
manner with a minimum of changing
hands. Additional factors were the attractive
real estate market, the burgeoning biotech market
in the Memphis area and the willing and capable
partners we have in Lifeblood, Federal Express,
the Memphis Biotech Foundation and the Memphis
Chamber of Commerce. Your companys spokesman,
quoted in Memphis Medical News, January 2005
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Biological Product Manufacturing

• Regulated by Food and Drug Administration
• Must adhere to applicable sections of the Code of
  Federal Regulations (CFR).
• Must adhere to applicable current Good
  Manufacturing Practices (cGMP).
• Must adhere to applicable current Good Tissue
  Practices (cGTP).
• Increasing number of regulations are being
  applied to manufacture of these products