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Sterile injectables capabilities at a glance

Services and processes

  • Aseptic fill-finish
  • Terminal sterilization
  • Lyophilization
  • Combination products
  • Secondary packaging and global supply chain services
  • Container closure systems including vials, syringes, ampoules and cartridges

Compounds

  • Biologics
  • Small molecules
  • Controlled substances (II-IV)
  • Liposomal Cytotoxics (liquid)
  • Vaccines (inactivated)
  • Monobactam
  • Sterile suspensions
  • Potent drugs
  • Hormones, steroids and prostaglandins
  • Diluents
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Lyophilization is challenging. We've been proudly doing it for more than 40 years

There are many complexities facing lyophilized product development and manufacturing. Using our extensive experience, we can optimize and scale-up your lyophilization process to match the needs of your unique compound at commercial scale.

By carefully considering your drug’s formulation, attributes and our lyophilization capabilities, our team of experts ensure proper cycle design every time.

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Capabilities at a glance

Sterile injectable manufacturing

  • Clinical 
  • Commercial 

 Manufacturing network includes: 

  • Australia (Melbourne)
  • China (Wuxi)
  • Croatia (Zagreb) 
  • Spain (Algete) 
  • United States (Kalamazoo, Michigan; McPherson, Kansas; Rocky Mount, North Carolina)

Services & processes

  • Aseptic fill-finish 
  • Terminal sterilization 
  • Lyophilization 
  • Combination products 

Compounds

  • Biologics 
  • Small molecules 
  • Controlled substances (II-IV) 
  • Liposomal 
  • Cytotoxics (liquid)
  • Vaccines (inactivated)
  • Monobactam 
  • Sterile suspensions 
  • Potent drugs 
  • Hormones, steroids & prostaglandins 
  • Diluents 

Global supply chain services

  • Serialization/track-and-trace programs 
  • On-site regulatory experts 
  • Gateway services, including quality release support and multi-lingual secondary packaging, labelling and package inserts 
  • Drug product storage and distribution: ambient (+15°C to +30°C), controlled room temperature (+15°C to +25°C), refrigerated (+2°C to +8°C), frozen (-15°C to -25°C) 

Container closure systems

  • Glass vials: 2mL – 100 mL 
  • Syringes (pre-filled syringes): 1mL – 5mL (tub configuration) 
  • Ampoules: 2mL – 10mL 
  • Cartridges

Secondary Packaging

  • Bulk (bright stock) 
  • Single-/multi-unit cartons 
  • Kitting

Expert Content

Explore Pfizer CentreOne Technology Transfer with Sterile Injectables

Access our Webinar

Considerations for migrating a drug product presentation from Vial to Pre-Filled Syringe

Download White Paper

Identifying ways to achieve a more resilient Sterile injectable supply chain

Read the Article

Explore our global sterile injectables manufacturing capabilities

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

Discover Kalamazoo

 

Algete, Spain

  • Specialist site for complex sterile injectable solutions
  • State-of-the-art high-speed pre-filled syringe line
  • Spacious, expertly managed warehouse facilities
  • Aseptic filling of proteins and small molecules that require high customer touch

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Algete Site

McPherson Site

 

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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Melbourne, Australia

  • Manufactures antibiotics, pain medication and oncology products
  • Produces material for both the Australian and international markets
  • Has a collaborative relationsip 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

Pearl River Site

Pearl River, New York, USA

  • Pfizer’s hub for highly potent and cytotoxic bioconjugates and complex molecule manufacturing, primarily ADCs
  • Over 100 years of manufacturing and developing oncology therapies and vaccines
  • Inspected and approved for global commercial product supply
  • In-house QC labs for in-process, release and stability testing

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Puurs, Belgium

  • Supplies over 400m doses annually to 170+ countries around the world
  • Clinical and commercial supply for controlled drugs and substances as well as highly active compounds
  • Specialist EU site for complex vaccine manufacturing
  • Highly flexible fill/finish including pre-filled syringe, ampoules, dual chamber vials, cartridge siliconization and lyophilization

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Puurs Site

Rocky mount site

Rocky Mount, North Carolina

  • This site provides around 50% of all Pfizer sterile injectable products in the US
  • Providing clinical and commercial supply for diluents, injectable high-potent and licensed for controlled substances
  • Multi-product manufacturing expertise including drug product and packaging services
  • Approved for clinical supply (manufacturing and primary packaging)

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Zagreb, Croatia

  • Clinical and commercial supply for biologics drug substances and drug products manufacturing
  • Highly technically capable team with R&D background
  • Site approved for clinical manufacturing
  • A range of analytical, packaging, drug substance and drug product capabilities

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Zagreb Site