Ann Marie McCormack, Quality Control, Ireland

Listening. Solving. Guiding.

We can help take your molecule all the way from early clinical phases through commercial launch and lifecycle management. Worldwide, our sites have been developing and manufacturing Pfizer’s broad array of innovative molecules for decades, and this legacy can help ensure a successful collaboration.


We offer an expert suite of development and optimization services including formulation, manufacturing, analytical testing, validation and method development. Access our wide range of capabilities to stay ahead of today’s therapeutic trends.

Development Services

 

Capabilities at a glance

  • Clinical manufacturing
  • Development of cell cultures and lab-based fermentation processes
  • API synthesis
  • Specialized lyophilization development and optimization technology
  • Manufacturing process support

 

  • Safety screening and hazard evaluations
  • Chemical and analytical development
  • Scale-up from pilot to commercial
  • Plant scale fermentation development
  • Regulatory support – pre and post-launch

Drug Substance

Small Molecule APIs

  • Full development of synthetic route
  • Raw material analysis
  • Process safety
  • Process optimization
  • Scale-up from lab to pilot to commercial
  • Full development of analytical methods 
  • Impurity assessment, fate and purge studies
  • Characterization of API
  • Specification development
  • Regulatory support - pre and post-launch
  • Clinical manufacturing Ph I - III
  • Optimization of cell cultures and lab-based fermentation processes
  • Plant scale fermentation development 

Large Molecule Biologics

  • 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

Drug Product

Oral Solids

  • Early stage formulation development
  • Process validation 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
  • Full range of OEB 1-5
  • Tablets, capsules, granules
  • Controlled substances (III - IV)

Sterile Injectables

  • Formulation development
  • Lyophilization cycle development and optimization
  • Process development
  • Aseptic process and terminal sterilization
  • 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
  • Full range of OEB 1-5
  • Vials, Ampoules, Prefilled Syringes, Cartridges
  • Controlled substances (II - IV)