Sterile Injectables Manufacturing Services | Pfizer CentreOne

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Sterile injectable manufacturing services

Excellence in every injection

Advance your sterile injectable program with Pfizer CentreOne’s flexible liquid and lyophilized manufacturing capabilities.

With decades of experience and regulatory intelligence spanning over 150 countries, we help tailor sterile injectable manufacturing to your program. From vials to pre-filled syringes (PFS) and cartridges, we provide sterile fill-finish services that support late-stage clinical supply, commercialization, and lifecycle management.

Automated fill-finish lines, single-use technologies, and dedicated Pfizer quality experts help safeguard sterility, data integrity, and patient safety across every dose. Because when time is life, speed matters—but never at the expense of quality.

Speak to our sterile injectable experts today

Our sterile injectable manufacturing capabilities at a glance

Compounds

Biologics
ADCs
Microbial therapies
Small molecules
Combination products
Controlled substances (II-IV)
Cytotoxics (liquid)
Hormones, steroids, and prostaglandins
Vaccines (inactivated and novel technologies)
Monobactam

Delivery systems

Liposomal
Microspheres
Fat emulsions
Nanocrystals
Albumin nanoparticles
Micelles
Sterile suspensions

Aseptic manufacturing processes

Sterile fill-finish
Terminal sterilization
Lyophilization
High-containment processing

Analytical services

Method development
Method validation
Method transfer
Stability testing
End-user studies

Container closure systems*

Glass vials (2 mL–100 mL)
Pre-filled syringes (1 mL–5 mL)
Cartridges (1.5 mL–5 mL)
Ampoules (2 mL–10 mL)
Secondary packaging

*Subject to change, inquire for specific requests

View brochure

Why choose Pfizer CentreOne for sterile injectable manufacturing?

Global expertise. Specialized capabilities

We support advanced delivery systems and complex therapeutics, including mAbs, ADCs, and novel vaccines.

Dedicated quality and analytical teams develop and optimize scalable manufacturing processes, while digitized technologies—including integrated lyophilizers and fill lines, automated loading and unloading, and single-use systems—help strengthen sterility assurance and process consistency.

Efficiently delivering reliability and quality.

With multiple filling lines, flexible packaging formats, and a global presence, we aim to accommodate shifting volumes and demand.

Transparent communication, real-time data visibility, and structured tech transfer help maintain alignment and control.

That discipline extends across our supplier network, where comprehensive evaluation helps strengthen supply chain continuity for safe, secure product delivery.

Flexible and transparent support you can rely on.

Our experts help deliver innovative sterile injectable manufacturing strategies and solutions tailored to your molecule and timeline.

Guided by our “right-first-time” approach and lightspeed principles, we help identify lead-time efficiencies without compromising quality.

This structured execution is supported by coordinated, strategically positioned global sites and regulatory support aligned to requirements across 150+ countries.

Our sterile injectable manufacturing network

Wherever your product is destined for market, we have the expertise and capabilities to help you deliver high-quality therapeutics.

Our global sterile injectable manufacturing network includes sites in Belgium, Croatia, Spain, Sweden, and multiple U.S. locations, including McPherson, Kansas. With purpose-built facilities, we support the production of complex biologics and small-molecule sterile injectables, including highly potent and cytotoxic oncology compounds.

Our facilities meet cGMP inspection standards across global regulators, including but not limited to:

FDA
EMA
MHRA
Health Canada
NMPA
PMDA
TGA

Discover our SI manufacturing network

Aseptic manufacturing excellence built on decades of experience

For over four decades, Pfizer CentreOne has supported aseptic lyophilization and liquid fill-finish for complex sterile injectables.

Our teams develop and validate freeze-drying cycles that protect stability and potency, particularly for sensitive biologics, while automated fill lines and controlled environments strengthen sterility assurance for liquid formulations.

Beyond sterile fill-finish, we provide customized secondary packaging, serialization, and controlled storage and distribution under ambient, refrigerated, and frozen conditions to protect drug product integrity.

Speak to our sterile injectable experts

Expert content

Overcome sterile injectable complexity through effective CMO collaboration

Download whitepaper

Get expert insights on sterile injectable development and manufacturing

Download the application note

Explore our sterile injectable manufacturing capabilities

Download the brochure

Discover key considerations for vial-to-PFS migration

Download the whitepaper

Podcast: Navigate sterile injectable fill-finish with us

For patients waiting for your medicines, time is life.

In this episode, Pfizer CentreOne sterile injectable leaders discuss emerging trends in complex biologics, tech transfer best practices, and the importance of transparency in capacity planning.

Together, these insights highlight how structured collaboration helps support confident progression from development to commercial supply.

Listen to the podcast

Meet our sterile injectables experts

Our scientific and manufacturing experts bring decades of experience to help advance your complex sterile injectables, so you can deliver life-saving treatments to patients worldwide.

Mietje De Volder

Sr Manager Supply Chain & Business Development

Mietje brings over 25 years of pharmaceutical experience to her role at Pfizer CentreOne Puurs. She draws on deep expertise across validation, quality compliance, supply chain, and contract manufacturing to enable successful partnerships and deliver high-quality products to patients worldwide.

Eva Sanchez

Manager of Business Development

Eva leads Pfizer CentreOne business development at the Algete site, bridging technical expertise and commercial strategy to help bring your medicines to patients. With over 18 years at Pfizer across technical services and operations, she brings extensive experience in sterile manufacturing and commercialization.

Jayma Alcala

Director, Pfizer CentreOne Site Lead

Jayma brings more than 23 years of aseptic manufacturing experience to her role as McPherson Pfizer CentreOne Lead. She oversees supply chain, technical transfer, and customer advocacy, drawing on extensive expertise in quality control, operations, and product launch execution.

Ready to advance your sterile injectable drug product?

Contact our experts to learn how we can help.

Let’s collaborate

FAQ

Can you handle highly potent or cytotoxic sterile injectables?

Yes. Our teams manage highly potent and cytotoxic compounds in purpose-built sterile injectable manufacturing facilities. We operate within controlled, high-containment aseptic environments and apply strict handling protocols to protect product integrity and operator safety.

Which Pfizer CentreOne sites have sterile injectable manufacturing capabilities?

Our sterile injectable manufacturing sites are located in Algete (Spain), Puurs (Belgium), Zagreb (Croatia), Strängnäs (Sweden), and across the U.S. in McPherson (KS), Andover (MA), and Pearl River (NY). Explore our global sterile injectable manufacturing network.

Do your facilities operate under cGMP standards?

Yes. Our sterile injectable manufacturing facilities operate under current Good Manufacturing Practice (cGMP) standards and undergo routine inspections by global regulatory authorities. Inspection experience includes FDA, EMA, PMDA, MHRA, Health Canada, ANVISA, NMPA, TGA, Korean FDA, GCC / GCC-DR, AIFA, COFEPRIS, Turkish MoH, Taiwanese MoH, EAEU, MOITRF, Kazakhstan, and Belarus.

Our regulatory team is well-equipped to support submissions to health authorities worldwide. Download our regulatory support brochure to learn more.

What is the difference between aseptic fill-finish and terminal sterilization?

Aseptic fill-finish involves sterilizing the drug product and its components separately, then filling and sealing the product in a controlled aseptic environment to maintain sterility. This approach helps preserve the stability of biologics and other temperature-sensitive compounds.

Terminal sterilization sterilizes the product in its final container after filling, typically using heat or radiation. It is often suitable for small molecules that can tolerate those conditions.

Pfizer CentreOne supports both aseptic fill-finish and terminal sterilization approaches.

Get in touch to discuss the best approach for your product.

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