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Biologics development capabilities at a glance

We’re experts in the production of therapeutic proteins using expression in recombinant organisms including:

  • Vaccines including native and conjugated polysaccharides, lipoproteins and soluble proteins in monovalent or multivalent presentations.
  • Proteins including monoclonal antibodies (mAbs), bi-specific clonal antibodies (BsAbs) fusion proteins and native proteins, with or without conjugation to payloads or half-life extenders (e.g. PEG).
  • We deliver reliable lyophilization as well as comprehensive vial and syringe drug product capabilities.

Other development capabilities include:

  • Cell culture medium development and optimization
  • Upstream and downstream process development and optimization
  • Full development of analytical methods
  • Scale-up from lab to pilot to commercial
  • Specification development
  • Regulatory support - pre and post-launch
  • Clinical manufacturing Ph I - III
  • Biosafety levels 1-2
  • Vaccines & monoclonal antibodies
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Explore our global biologics development capabilities

sanford

 

Sanford, North Carolina, USA

  • Employs over 1,400 colleagues

  • 35 years in operation

  • Highly skilled workforce with patient focused culture

  • Sustainably-focused energy and utility systems

  • Warehousing with multiple temperature storage conditions

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McPherson, Kansas, USA

  • 125+ million drug product units produced annually
  • Manufactures biologics, mAbs and complex vaccine
  • Dosage form flexibility including low, single and dual doses as well as combination products
  • Specialist CarpujectTM syringe system packaging site

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McPherson Site

Kalamazoo Site

Kalamazoo, Michigan, USA

  • The largest manufacturing site in the Pfizer network
  • Produces approximately 1 million kg of API and 10 million kg of intermediates every year
  • Manufactures antibiotics, hormones and vaccines as well as rare disease and oncology treatment
  • Designated a National Chemical Historic Landmark by the American Chemical Society

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Melbourne, Australia

  • Manufactures antibiotics, pain medication and oncology products
  • Produces material for both the Australian and international markets
  • Has a collaborative relationship with research and academic institutions
  • Clinical and commercial supply for complex injectable high-potent cytotoxic, liposomal and nanoparticle formulations

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Melbourne Site

ascoli

Sanford North, North Carolina, USA

  • State-of-the-art mammalian drug substance manufacturing facility
  • Targeting first half of 2024 for GMP readiness
  • Current build includes: four manufacturing suites, QC analytical and micro labs, a warehouse, office areas, central utility building
  • Analytical and microbiological testing (in-process and release)
  • Ability to handle high titer processes via perfusion capability

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