Shape your development masterpiece
For over 40 years, Pfizer CentreOne has been listening, solving, and guiding its partners’ drug projects on the journey to patients. By taking an open and collaborative approach to drug development and manufacturing, our CDMO assures full transparency by continually striving to deliver on our promises.
Products & Services
Draw upon the scientific mastery of Pfizer CentreOne’s team of creative scientists and problem-solvers to overcome your greatest drug development and manufacturing challenges.
With expertise across a global network, our CDMO delivers the development, manufacturing, technical, quality, regulatory, and supply requirements you need at scale across every step of your journey.
Dedicated to a culture of confidentiality, Pfizer CentreOne strives to ensure that your IP is given the highest level of protection, so your secrets are always safe with us.
- Development services
- Clinical manufacturing
- Development of cell cultures and lab-based fermentation processes
- API synthesis
- Specialized lyophilization development and optimization technology
- Manufacturing process optimization
- 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
- Clinical & commercial manufacturing
Small Molecule APIs
- Fermentation, biotransformations, complex multi-step synthesis, cryogenic chemistry, hydrogenation, chromatography, halogenations, milling and micronizing
Oral Solids- Tablets, capsules, semi-solids, wet/dry granulation, blending, coating, extrusion, compression, printing, high containment and hormone manufacture
Large Molecule Biologics- Microbial fermentation, mammalian cell culture, viral cell culture, vaccines, cytotoxin production, purification and pegylation
Sterile Injectables- Aseptic and terminally sterilized filling of liquids, powder and suspensions, lyophilization, vials, ampoules, pre-filled syringes, IV bags/bottles, auto-injectors and surgical hemostatic devices
- Regulatory affairs & lifecycle management
Development
- Scope opportunities: Due diligence
- Regulatory strategy: Clinical trial application author and support
- Quality/supply agreement input and review
Commercial- Authoring/review of the initial submission
- Review Agency meetings: Serve as liaison with site CMC and QA & support for deficiency responses
- Labeling development for drug products
- Support for launch
Lifecycle Management- Post approval submission: Strategy development and documentation authoring/review
- Annual reports: Due date tracking, maintenance and compilation
- International registration support
- Review and assessment of change controls
- Management of associated DMFs
Press Releases
November 2023
11.28.2023
11.21.2023
11.16.2023
11.02.2023
11.02.2023
11.01.2023
Corporate Partnerships Stanford Medicine Launches New Global Health Scholars Program for African Physicians
October 2023
10.31.2023
10.26.2023
10.20.2023
10.15.2023
10.13.2023
10.13.2023
Prescription Medicines Medicines U.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC)
Pfizer Partnerships
Partnerships save lives. We’re eager to work with innovators who share our values and our focus to discover and develop breakthroughs that change patients’ lives.
