CSL Bioplasma

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CSL Bioplasma Rodger Hyde Issues in
Contract Fractionation
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GeneralIssues
About CSL
Process
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GeneralIssues
About CSL
Process
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Countries that collect blood have three options
for surplus plasma
GeneralIssues
Most of the developed world France, Netherlands,
Belgium, Sweden, Australia, Canada, New Zealand,
Malaysia, Singapore, Japan
FRACTIONATE IT
USE IT
US / Germany / Switzerland
SELL IT
PLASMA
DISCARD IT

• Only done where plasma is substandard
• UK
• Developing countries with poor quality standards

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Why fractionate?
GeneralIssues
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• Security of supply
• Not dependant on another countrys surplus plasma
• Maximising the use of a valuable and scarce
  resource
• Control

It makes sense to fractionate surplus plasma
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Self-sufficiency for plasma products requires
Government support to succeed
GeneralIssues
GeneralIssues

• In times when products from some fractions are in
  oversupply, major international exporters can
  sell products below full cost
• To protect against this, self-sufficiency is
  protected by support mechanisms
• Regulated preference in the market
• Australia, New Zealand, Japan, China, Korea,
  Taiwan, Hong Kong, Malaysia
• Protection from economic forces
• Government ownership and subsidy (e.g. BPL in UK)
• Free plasma

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Product Mix is an important consideration
GeneralIssues
GeneralIssues

• Fractionation costs are driven by litres of input
  plasma not product output
• Fractionators seek to maximise the number of
  products from a litre of plasma
• The higher the number of products from each litre
  of plasma, the lower the cost of each product

Fixed and Joint Costs
Product 1
Product cost where 1 product is manufactured
Product 1
Product 3
Product 2
Product cost where 3 products are manufactured
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GeneralIssues
About CSL
Process
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Selecting a contract fractionation partner
GeneralIssues
Process

• Experience, history and reliability
• Understanding of regional issues
• Commitment to ongoing development
• Safety record
• Technology
• Product Yields
• Product Portfolio

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Ensuring appropriate support mechanisms are in
place
GeneralIssues
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Process

• Legislative support
• Working with Government to establish legislative
  frameworks to ensure product has preference in
  the market
• Cost structure
• Ensuring little or no cost is assigned to plasma
• Provision of products that are equal to the best
  in the world
• Support from the medical community

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Understanding product requirements
GeneralIssues
GeneralIssues
Process

• Product Mix
• Understanding clinical requirements for each
  product
• Plasma volumes
• Type of services required

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Qualifying plasma supply
GeneralIssues
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Process

• Plasma and blood collection centres must be
  approved by the regulator governing the
  fractionation partner
• Can often take a significant amount of time
• Work with fractionation partner to audit blood
  collection centres and implement required systems
• Requires investment of resources and
  collaboration between Blood Service and
  fractionation partner
• Approval of Plasma Master File

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Implementing contract fractionation
GeneralIssues
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Process

• Registration of products
• Selection of logistics provider
• Qualifying the supply chain
• Implementation of operational systems
• Ongoing product and clinical support
• Medical Education

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GeneralIssues
About CSL
Process
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CSL Group is the worlds largest supplier of
contract fractionation services
About CSL

• Long history of working with nations committed to
  self-reliance for plasma products
• Australia, Denmark, New Zealand
• CSL Bioplasma is the leading contract
  fractionator in the South East Asian region
• Hong Kong, Singapore, Malaysia
• World-leading range of plasma therapeutic
  products
• 2 dedicated viral inactivation steps
• Very high purity
• Excellent yields
• Outstanding safety record

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World leading chromatographic technology
About CSL

• Key features and advantages of chromatography
• Higher yields
• Higher purity
• Lower adverse reaction rates i.e. IgA in IVIG
• Prion and virus clearance