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Sterile Injectables Development

Sterile Injectable Development
An exact SI-ence

Pfizer CentreOne is a leading global CDMO dedicated to unlocking the potential of your sterile injectable.

Time is life, and in the rapidly evolving sterile injectable space, expertise is key to helping ensure te safe, successful delivery of your innovative therapeutic to the patients who need it.

As an experienced partner with an uncompromising commitment to quality, flexibility and transparency, we can help you skillfully maneuver through complexities, keeping pace with both scientific advancements and regulatory requirements.

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Sterile injectable capabilities at a glance

Sterile injectables

Formulation development
Lyophilization cycle development and optimization
Process development
Aseptic process and terminal sterilizatio
Full development of analytical methods
Scale-up from lab to pilot to commercial

Specification development
Regulatory support - pre- and post-launch
Clinical manufacturing Phase I - III
Full range of OEB 1-5
Vials, Ampoules, Prefilled Syringes, Cartridges
Controlled substances (II - IV)

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Expert Content

Read how collaboration and the drive to find a workable solution led to a successful drug development program

Read the Case Study

Explore how successful CDMO collaboration sets the foundation for Sterile Injectable product success

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Explore Pfizer CentreOne Technology Transfer with Sterile Injectables

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Explore our global sterile injectables development capabilities

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 dose as well as combination product
Specialist CarpujectTM syringe system packaging site

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Andover, Massachusetts, USA

Supports the continuous innovation of a range of drug substance, drug product and vaccinations
Capable of multi-stage and multi-scale biological compounds microbial fermentation
Multi-product manufacturing expertise in Cold chain handling and warehousing and integrated inspection and packaging
Capabilities span from cell line development in R&D to 12kl scale commercial monoclonal antibody (mAb) production

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

Discover Puurs

Sterile Injectable Development An exact SI-ence