Contract Pharmaceutical Manufacturing
Pfizer CentreOne specializes in commercial manufacturing for oral solids, sterile injectables, and biologic drug products. With seamless process optimization, scalable production, established IP protection and regulatory excellence to give you the confidence you need throughout your journey.
We harness Pfizer’s manufacturing network, expertise and capabilities across the spectrum of drug substance, drug products and pharmaceutical delivery methods.
- Oral Solid Dosage
Our scientific experts bring decades of experience and a strong track record of delivering high-quality OSD products, including highly potent, cytotoxic, controlled and low-bioavailability drugs. From pellets, capsules and tablets to innovative release profiles, we’re here to help you master your complex OSD needs, seamlessly and simply.
- Sterile Injectables
Pfizer's global network of scientific and manufacturing experts leverages decades of experience to support a broad range of complex therapeutics. Our specialized facilities are designed to unlock the full potential of your SI drug substance (liquid or lyophilized) and product (PFS, vials, cartridges). Including those for oncology medicines, novel vaccines, monoclonal antibodies (mAbs) and beyond.
- Antibody-drug conjugates
With over two decades of experience in antibody-drug conjugate (ADC) innovation, Pfizer CentreOne offers comprehensive manufacturing capabilities, encompassing cytotoxic compounds, drug substance intermediates, specialized cytotoxic payloads, linkers, final ADC assembly & drug product needs.
- Microbial Fermentation
Pfizer CentreOne offers scalable microbial fermentation manufacturing services, encompassing late-stage clinical and commercial support with experienced Pfizer teams, integrated upstream fermentation and downstream purification, cell banking, and GMP quality and analytical expertise.
Our Manufacturing Services
By using the latest technologies and harnessing the scientific excellence of our highly-skilled experts and manufacturing sites around the world, we’re on a mission to help deliver the quality and flexibility you need to lead your project to success – because for patients time is life.
Analytical support
- cGMP-compliant laboratories
- Full suite of analytical tools
- Cleaning method development, validation and recovery studies
Process development
- Process optimization, including: Telescoping and reaction monitoring through PAT
- Process throughput
Manufacturing
- Scale-up
- Stability studies
- Process safety management
- Regulatory submission support
Regulatory, Tech Transfer and Lifecycle Support
With access to some of the best regulatory minds in the industry at Pfizer, we can help you with your regulatory affairs challenges.
Pfizer CentreOne brings your project into advanced digital infrastructure, batch strategy and quality systems — helping meet the rising demand for seamless, efficient and accelerated tech transfer.
Pfizer CentreOne supports customers throughout the product lifecycle by sharing Pfizer’s extensive regulatory and manufacturing experience. Our regulatory intelligence spans 150+ countries to support a wide range of global regulatory requirements.
Our regulatory support includes:
- Post-approval submission support
- Annual report support
- International registration support
- Change control and review assessment
- Drug Master File (DMF) support
Ready to help build your lasting legacy
Your breakthrough therapies deserve the support of a CMO as committed as you are. Pfizer CentreOne can help bring your life changing treatments to the patients waiting globally.
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