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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
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- 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
April 2023
04.27.2023 Vaccines U.S. FDA Approves PREVNAR 20®, Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children 04.27.2023 Corporate Finance Pfizer Announces 2023 Shareholder Meeting Preliminary Results 04.26.2023 Financial Finance Pfizer Declares Second-Quarter 2023 Dividend 04.13.2023 Financial Finance Pfizer Invites Shareholders to Attend Virtual-Only 2023 Annual Meeting of Shareholders on April 27 04.04.2023 FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
March 2023
03.21.2023 Financial Finance Pfizer Invites Public to View and Listen to Webcast of May 2 Conference Call with Analysts 03.16.2023 Medicines Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer 03.16.2023 Covid-19 Medicines FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™ 03.14.2023 Vaccines Covid-19 Vaccines Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years 03.13.2023 Financial Investments Pfizer Invests $43 Billion to Battle Cancer 03.10.2023 Medicines Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval 03.01.2023 Vaccines Covid-19 Vaccines Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years
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.
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