Range of Services: Clinical Phases to Lifecycle Management 

 

Pfizer CentreOne Manufacturing Site in Melbourne, Australia

Made with intelligent collaboration

We’re embedded within Pfizer so you’ll be supported by our team and backed by the tools, processes and experience of one of the world’s leading injectables manufacturers. 

With its own portfolio of biopharmaceuticals and injectables, Pfizer continually invests in our manufacturing sites to maintain them at the cutting edge of technology. 

We have regulatory knowledge on a global scale and established regulatory approvals in multiple markets including the U.S. FDA (United States), EMA (European Union), ANVISA (Brazil) and PMDA (Japan). 

We’re known for our manufacturing expertise in Biologics, Small molecules, Cytotoxics (liquid), and Lyophilization. 

Lyophilization is challenging. Proudly, we’ve been doing it for more than 40 years. 

Lyophilized product development and manufacturing is complex. We have the expertise to optimize and scale-up your lyophilization process to match the needs of your unique compound at commercial scale. 

Our experts carefully consider your drug’s formulation, attributes and our lyophilization capabilities to ensure proper cycle design. 

Tim Fairbanks, Pharmaceutical Attendant, United States

Manufacturing

  • Clinical 
  • Commercial 

 Manufacturing network includes: 

  • Australia (Melbourne)
  • Belgium (Puurs) 
  • China (Hangzhou) 
  • Croatia (Zagreb) 
  • Ireland (Grange Castle) 
  • 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 
  • Liquid cytotoxics 
  • Inactivated vaccines 
  • 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 (PFS): 1mL – 3 mL (tub configuration) 
  • Ampoules: 2mL - 10mL 

Secondary Packaging

  • Secondary packaging development including customized kits 
  • Bulk (bright stock) 
  • Single-/multi-unit cartons 
  • Kitting