Outsourcing Biologics Manufacturing in Europe

1
Outsourcing Biologics Manufacturing in Europe

• Kent Iverson
• Biopharmaceutical Manufacturing and Development
  Consultant

2
Scope of Presentation

• Subject biologics (recombinant protein and
  monoclonal antibody products)
• Based upon experience with
• Managing the outsourced production of clinical
  and commercial stage biologics (including Enbrel
  and Bexxar )
• Projects conducted with Lonza Biologics (Slough,
  UK) and Boehringer Ingelheim Pharma (Biberach,
  Germany)

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Biologics CMO Market

• Results of a recent CMO market assessment
  project
• GMP E.coli capable CMOs
• Europe 18
• North America 16
• Asia/Pacific 6
• Other 1
• GMP Cell Culture capable CMOs
• North America 24
• Europe 19
• Asia/Pacific 4
• Other 1
• Relatively high percentage of new entrants to
  market
• New CMOs tend to have some teething issues

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Why Europe?

• High probability of successful execution
• Oldest biologics production operations in the
  contract mfg space BI Pharma, Biochemie,
  Biovitrum, Lonza all have gt10 years of operation
  and commercial experience
• Relatively low personnel turnover and high
  experience retention
• Cultural bias towards reliability and
  systematically constructed, iteratively refined
  technology and procedures
• Commercial Biologics contract manufactured in
  Europe for the US market include Bexxar,
  Campath, Enbrel, Natrecor, Synagis, Zenapax
• Unique technical capabilities (within the
  contract mfg market)
• Well established commercial scale facilities (BI
  Pharma and Biochemie)
• Well established mammalian expression technology
  (Lonza)
• Capabilities covering virtually all CMC
  activities from pre-IND development through
  commercial supply can be sourced in Europe

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Why Not Europe?

• Cost Relatively high labor cost region and
  currency exchange currently works against
  US-based buyers
• Relationship management requires more skill,
  effort and acceptance
• Time difference and physical distance reduces
  frequency of face to face interactions
• Language and cultural differences can pose
  communication and relationship management
  challenges
• Quality emphasized over time and cost

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Outsourcing Biologics Mfg to a European Site

• The Clients team needs to include
• A senior management representative who
  participates in the relationship
• Team members who plan, coordinate and prioritize
  their activities
• Business practices that produce clear,
  prospective and detailed plans and communications
  to the CMO
• Team members who do not mind traveling (up to
  once a month for a week at a time during certain
  phases of the project)
• Team members who are willing to invest time in
  relationship building (dinners, etc. with the
  CMOs representatives)
• Things to consider
• Europeans generally are non-confrontational and
  their communications can contain layers of
  meaning (what sounds like a yes may be a no)
• Europeans tend to anticipate long term
  relationships
• Europeans tend to respect organizational
  hierarchy and expect the same from their partners
• Europeans expect to receive consistent
  messages/instructions from representatives of
  their partners
• Europeans tend to value reliability and keep
  their commitments within the boundaries of what
  they know is achievable

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European CMOs

• Are a good fit for Clients that
• Value certainty/reliability over cost and
  flexibility
• Need to access to, and are willing to share
  responsibility for CMC development and
  manufacturing
• Dont mind travel

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Closing Comments

• The international biologics contract mfg market
  is changing rapidly distinctions between
  technical capabilities of different regions are
  diminishing
• Biologics production and development skills take
  more time to develop than production capacity (a
  facility is not necessarily capability)
• Success in outsourcing is dependent in part upon
  inter-organizational management skills and
  greater skills are needed when outsourcing
  outside of the US
• Maintain pragmatism and mutual respect