Biologics

With decades of experience in taking your molecules from lab to patient, we’ve learnt invaluable lessons in the development and manufacturing of a wide range of biologics. At Pfizer we can help in the development and manufacturing of a range of therapeutic proteins and antibodies using expression in recombinant organisms including vaccine drug substance and intermediates, therapeutic proteins, monoclonal antibodies (mAbs), antibody drug conjugates (ADCs) and mAb biosimilars. Our global network of scientists, analysts and manufacturing experts are ready to help bring your breakthrough to light. 

Collaborating with Pfizer CentreOne means accessing the expertise and experience of a partner that has been on the journey before and therefore reaching biologic clinical and commercial milestones with confidence. 

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Capabilities at a glance

Biologics development capabilities

  • 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 and monoclonal antibodies

Biologics manufacturing capabilities

  • Lyophilization of intermediates
  • Raw material sourcing
  • Cell bank storage
  • Wave expansion
  • GE X cellerex XDR 2000 bioreactor
  • Viral filtration
  • Tangential Flow Filtration (TFF)
  • Chromatography
  • Extractables and Leachables (E&L) studies
  • Comprehensive sterile filling capabilities including lyophilization and pre-filled syringe

Biologics Development

We provide you with access to biologics experience and compelling science to help you reach your key development milestones with confidence. Our team has rich experience in biologic development including gene and cell therapy scientist, leveraging many years of working in this space to build and optimise our gene and cell therapy platform.  Access our capabilities and teams integrated with broader Pfizer technical and development expertise now.

Discover our biologics development expertise

Biologics Manufacturing

Harnessing Pfizer’s extensive scientific expertise and global manufacturing network, we deliver science at its best and global regulatory support to help bring your biologic to patients. We deliver end-to-end analytical and manufacturing expertise and provide molecule support from early clinical phases through to commercial launch. We leverage our development and technology transfer expertise to help bring your product to market as quickly as possible!

Discover our biologics manufacturing expertise

Expertise to bring your mammalian and microbial derived biotherapeutics to market, including monoclonal antibodies (mAbs)

Extensive experience

  • Proven history in producing therapeutic proteins and antibodies using expression in recombinant organisms
  • Therapeutic proteins, monoclonal antibodies (mAbs) and mAb biosimilars
  • Extensive testing experience, bioassays and protein-specific techniques
  • Partnering with customers to enable seamless integration across the entire lifecycle of your molecule

A solid foundation for success

  • 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
  • Clinical manufacturing Ph 1-3
  • Biosafety levels 1-2

Support with innovation and scalability

  • State-of-the-art manufacturing facilities located around the world
  • Single-use facilities with the ability to switch to stainless steel in solutions prep and centrifugation
  • Clinical manufacturing to commercial capability
  • Cold-chain handling and warehousing
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20+ years of antibody drug conjugate (ADC) innovation

Experts at the forefront of ADC progression

  • The world’s first commercial approved ADC product (Mylotarg™️)
  • Experts with advanced degrees and extensive ADC manufacturing experience
  • A track record of outstanding safety performance, successful technical transfers and on-time delivery

Integrated capabilities

  • End-to-end capability from cytotoxic compounds and drug substance intermediates to sterile drug products
  • Fermentation, recovery, chemical synthesis and purification capabilities
  • High-value formulations in a wide range of vial sizes and doses
  • The entire product flow path is single-use, eliminating the risk of product cross contamination and facilitating product changeover

Specialized facility to support ADCs’ unique needs

  • Pearl River ADC operation provides a full range of contract manufacturing services from a single site
  • Fully qualified facility producing commercial and clinical ADCs following cGMP practices
  • Approximately 94,000 sq ft of world-class manufacturing space
  • Site designed for cytotoxic drug processing
  • Bulk packing of vials in containment trays
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Here to help bring your gene and cell therapy to light

Technical expertise

  • 70+ experienced gene and cell therapy Pfizer scientists
  • Several years of experience from Pfizer’s internal research and pipeline optimization
  • Expertise developing and manufacturing scalable viral vectors across multiple serotypes

Capabilities and quality

  • World-class manufacturing space in North Carolina, USA (approximately 300,000 sq ft)
  • Clinical to commercial capability
  • Single-use mobile equipment Industry leading yield and productivity ratios
  • Batches ranging from 200-2000 liters
  • 40+ GMP batches and 100+ transfections

Time is life

  • Global network of scientists, regulatory experts, and analytical and quality control engineers that help reduce:
    • Wait times for manufacturing suite access
    • Process scale-up time
    • End-to-end process cycle time
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Vaccines made with compelling science and decades of expertise

Leveraging Pfizer’s history of expertise

  • Experience in producing therapeutic proteins in recombinant organisms
    • Including vaccine drug substance/intermediates
  • Success in commercial and clinical trial material production
    • Including critical vaccine starting material and protein drug substance intermediate (DSI)
  • Robust quality systems: reliable lyophilization vial and syringe drug product capability

Specialist solutions

  • Cold chain qualification and handling across entire manufacturing and packaging process
  • Process development (upstream, downstream, conjugation)
  • Analytical development and validation
  • Process characterization
  • Yields optimization expertise
  • Pfizer's robust quality systems

Full scope of manufacturing capabilities

  • Multi-product trains for manufacturing vaccine intermediates and drug substances for both commercial vaccines and clinical trial materials
    • Pneumo DSI and DS, and polysaccharides and toxoid DSI
  • Large-scale microbial fermentation, purification, conjugation, cell banking
  • BSL 2+ facility design
  • Packaging and distribution
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Expert Content

Read about Liposomal and Nanoparticle Technology at Pfizer Melbourne

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Read about our Large Molecule Biologic Expertise in our Brochure

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What to look for in a gene and cell therapy CDMO partner

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