Our CDMO leverages Pfizer’s cutting-edge development and commercial manufacturing solutions to offer contract development & manufacturing services from small to large scale for oral solids, sterile injectables, small molecules and biologics; as well as regulatory services.
Pfizer CentreOne harnesses Pfizer’s manufacturing network, expertise and capabilities across the spectrum of drug substance, drug products and pharmaceutical delivery methods.
- Oral Solid Dosage
Experts in oral solid dosage, Pfizer CentreOne draws on its global network to support our partners in developing and manufacturing tablets, capsules, pellets and other solid dosage forms using advance manufacturing capabilities in semi-solids, wet/dry granulation, blending, coating, extrusion, compression, printing, high containment and hormone manufacture.
- Sterile Injectables
Around the world, our Pfizer scientific and manufacturing experts leverage their decades of experience supporting a broad range of complex therapeutics - alongside our specialized facilities to unlock the potential of your SI drug substance (liquid or lyophilized) and product (PFS, vials, cartridges).
Our sterile injectables platform includes deep knowledge and experience helping partners with:
- aseptic manufacturing and sterilized fill-finish manufacturing
- powder and suspensions
- pre-filled syringes
- IV bags/bottles
- Large Molecule Biologics
Pfizer CentreOne’s biologics production capabilities include:
- antibody drug conjugate (ADC)
- microbial fermentation
- monoclonal antibodies (mAbs)
- mammalian cell culture
- Small Molecule APIs
Pfizer CentreOne supports our partners in custom small molecule API manufacturing, with significant experience in:
- complex multi-step synthesis
- cryogenic chemistry
- milling and micronizing
- Pharmaceutical APIs & Intermediates
A steady supply of critical ingredients for over 50 years. Off the shelf pharma APIs and intermediates available in reliable supply in both clinical and commercial quantities:
- Enviero Progesterone
- Steroid Intermediates
- Cell and Gene Therapy
Contract Pharmaceutical Development Services
Pfizer CentreOne’s pharmaceutical development services cover the entire pharmaceutical development lifecycle, including:
- 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
We offer lifecycle support to our partners, drawing upon the scientific mastery of Pfizer CentreOne’s team of creative scientists and problem-solvers.
Drawing on decades of experience and our global network of regulatory specialists, Pfizer CentreOne helps plan and execute complex pharmaceutical tech transfer projects at scale.
Pfizer CentreOne provides pharmaceutical contract regulatory services including support and guidance across our portfolio of modalities. We have regulatory intelligence for more than 150 countries, to support you with many regulatory requirements around the globe.
We offer our partners our expertise and experience in:
- 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
Discover what makes Pfizer CentreOne altogether different
For decades, 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.