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We’ve traveled the route so often, we can steer you past common hazards and handle unexpected problems with confidence.

Pfizer CentreOne has been providing sterile injectables fill-finish for more than 30 years. During that time, we’ve helped our biopharma partners overcome many technical challenges, such as:

  • Uncommon interactions between API and container closure systems
  • Hard-to-procure commodities that could threaten launch timelines
  • Impediments to scale-up, such as rapid compound degradation
  • Unexpected or unidentified impurities in the API

We’re intimately familiar with the regulatory landscape, too. Having practical regulatory filing knowledge of markets around the world, we can assist you in designing a regulatory strategy that helps you steer clear of mishaps and do-overs.

Our collaboration with you begins as early as Phase II. Development activities include:

Formulation optimization

  • Small and large molecules; liquid and lyophilized formulations; and sterile suspensions
  • Drug characterization for physical and chemical properties
  • Solubility and solution stability studies, including pH profiles
  • Excipient/compound compatibility studies
  • Container closure system selection
  • Extractable and leachables (E&L) testing

Analytical method development

  • cGMP-compliant laboratories
  • Impurities and degradation identification
  • Compendial method verification
  • Method development for bacterial endotoxin, sterility, preservative effectiveness, bioburden and low endotoxin recovery

Process development

  • Cleaning method development, validation and recovery studies
  • Solution path compatibility studies
  • Sterilization cycle development and validation
  • Sterility process development testing and bioburden validation
  • Scalability studies
  • Lyo-cycle optimization

Regulatory support

  • Registration and post-approval strategies
  • Regulatory agency inquiries and inspections
  • Lifecycle management support, such as new country registrations, scale-up and label-content changes