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Biologics Development

Biologics Development

Backed by the scientific resources and global manufacturing network of Pfizer, we deliver science at its best and global regulatory support for your biologics development. We provide access to large molecule biologics experience and compelling science to help partners reach key development milestones with confidence.

We’ll help guide your large molecule biologics from development to commercial-scale manufacture, and our unwavering commitment to your IP confidentiality means the secret to your success is always safe with us.

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Biologics development capabilities at a glance

We’re experts in the production of therapeutic proteins using expression in recombinant organisms including:

Vaccines including native and conjugated polysaccharides, lipoproteins and soluble proteins in monovalent or multivalent presentations.
Proteins including monoclonal antibodies (mAbs), bi-specific clonal antibodies (BsAbs) fusion proteins and native proteins, with or without conjugation to payloads or half-life extenders (e.g. PEG).
We deliver reliable lyophilization as well as comprehensive vial and syringe drug product capabilities.

Other development capabilities include:

Cell culture medium development and optimization
Upstream and downstream process development and optimization
Full development of analytical methods
Scale-up from lab to pilot to commercial
Specification development
Regulatory support - pre and post-launch
Clinical manufacturing Ph I - III
Biosafety levels 1-2
Vaccines & monoclonal antibodies

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Expert Content

Read about how to navigate the antibody landscape in our technical application note

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A CDMO with experience enabling accelerated tech transfer success

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Read about our approaches to drug product development

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Gene and cell therapy analytical and development methods: A path to success

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Explore our global biologics development capabilities

sanford

Sanford, North Carolina, USA

Employs over 1,400 colleagues
35 years in operation
Highly skilled workforce with patient focused culture
Sustainably-focused energy and utility systems
Warehousing with multiple temperature storage conditions

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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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McPherson Site

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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Melbourne, Australia

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

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ascoli

Sanford North, North Carolina, USA

State-of-the-art mammalian drug substance manufacturing facility
Targeting first half of 2024 for GMP readiness
Current build includes: four manufacturing suites, QC analytical and micro labs, a warehouse, office areas, central utility building
Analytical and microbiological testing (in-process and release)
Ability to handle high titer processes via perfusion capability

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