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Sterile Injectables Manufacturing

Sterile Injectables Manufacturing
An Exact SI-ence

As an experienced partner with an uncompromising commitment to quality, flexibility and transparency, we can help you unlock the potential of your sterile injectable.

By skillfully maneuvering through the complexities of sterile injectable manufacturing, we keep pace with both scientific advancements and regulatory requirements.

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Sterile injectables capabilities at a glance

Services and processes

Aseptic fill-finish
Terminal sterilization
Lyophilization
Combination products
Secondary packaging and global supply chain services
Container closure systems including vials, syringes, ampoules and cartridges

Compounds

Biologics
Small molecules
Controlled substances (II-IV)
Liposomal Cytotoxics (liquid)
Vaccines (inactivated)
Monobactam
Sterile suspensions
Potent drugs
Hormones, steroids and prostaglandins
Diluents

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Lyophilization is challenging. We've been proudly doing it for more than 40 years

There are many complexities facing lyophilized product development and manufacturing. Using our extensive experience, we can optimize and scale-up your lyophilization process to match the needs of your unique compound at commercial scale.

By carefully considering your drug’s formulation, attributes and our lyophilization capabilities, our team of experts ensure proper cycle design every time.

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Capabilities at a glance

Sterile injectable manufacturing

Clinical
Commercial

Manufacturing network includes:

Australia (Melbourne)
China (Wuxi)
Croatia (Zagreb)
Spain (Algete)
United States (Kalamazoo, Michigan; McPherson, Kansas; Rocky Mount, North Carolina)

Services & processes

Aseptic fill-finish
Terminal sterilization
Lyophilization
Combination products

Compounds

Biologics
Small molecules
Controlled substances (II-IV)
Liposomal
Cytotoxics (liquid)
Vaccines (inactivated)
Monobactam
Sterile suspensions
Potent drugs
Hormones, steroids & prostaglandins
Diluents

Global supply chain services

Serialization/track-and-trace programs
On-site regulatory experts
Gateway services, including quality release support and multi-lingual secondary packaging, labelling and package inserts
Drug product storage and distribution: ambient (+15°C to +30°C), controlled room temperature (+15°C to +25°C), refrigerated (+2°C to +8°C), frozen (-15°C to -25°C)

Container closure systems

Glass vials: 2mL – 100 mL
Syringes (pre-filled syringes): 1mL – 5mL (tub configuration)
Ampoules: 2mL – 10mL
Cartridges

Secondary Packaging

Bulk (bright stock)
Single-/multi-unit cartons
Kitting

Expert Content

Explore Pfizer CentreOne Technology Transfer with Sterile Injectables

Access our Webinar

Considerations for migrating a drug product presentation from Vial to Pre-Filled Syringe

Download White Paper

Identifying ways to achieve a more resilient Sterile injectable supply chain

Read the Article

Explore our global sterile injectables manufacturing capabilities

Kalamazoo Site

Kalamazoo, Michigan, USA

The largest manufacturing site in the Pfizer network
Produces approximately 1 million kg of API and 10 million kg of intermediates every year
Manufactures antibiotics, hormones and vaccines as well as rare disease and oncology treatment
Designated a National Chemical Historic Landmark by the American Chemical Society

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Algete, Spain

Specialist site for complex sterile injectable solutions
State-of-the-art high-speed pre-filled syringe line
Spacious, expertly managed warehouse facilities
Aseptic filling of proteins and small molecules that require high customer touch

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Algete Site

McPherson Site

McPherson, Kansas, USA

125+ million drug product units produced annually
Manufactures biologics, mAbs and complex vaccine
Dosage form flexibility including low, single and dual doses as well as combination products
Specialist CarpujectTM syringe system packaging site

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Melbourne, Australia

Manufactures antibiotics, pain medication and oncology products
Produces material for both the Australian and international markets
Has a collaborative relationsip with research and academic institutions
Clinical and commercial supply for complex injectable high-potent cytotoxic, liposomal and nanoparticle formulations

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Pearl River Site

Pearl River, New York, USA

Pfizer’s hub for highly potent and cytotoxic bioconjugates and complex molecule manufacturing, primarily ADCs
Over 100 years of manufacturing and developing oncology therapies and vaccines
Inspected and approved for global commercial product supply
In-house QC labs for in-process, release and stability testing

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Puurs, Belgium

Supplies over 400m doses annually to 170+ countries around the world
Clinical and commercial supply for controlled drugs and substances as well as highly active compounds
Specialist EU site for complex vaccine manufacturing
Highly flexible fill/finish including pre-filled syringe, ampoules, dual chamber vials, cartridge siliconization and lyophilization

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Rocky mount site

Rocky Mount, North Carolina

This site provides around 50% of all Pfizer sterile injectable products in the US
Providing clinical and commercial supply for diluents, injectable high-potent and licensed for controlled substances
Multi-product manufacturing expertise including drug product and packaging services
Approved for clinical supply (manufacturing and primary packaging)

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Zagreb, Croatia

Clinical and commercial supply for biologics drug substances and drug products manufacturing
Highly technically capable team with R&D background
Site approved for clinical manufacturing
A range of analytical, packaging, drug substance and drug product capabilities

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Sterile Injectables Manufacturing An Exact SI-ence