GMP AAV Manufacturing

Pharmaron’s Gene Therapy CDMO, located in Liverpool, UK, leverages its industry-leading expertise in process R&D, cGMP manufacturing and advanced analytical capabilities to support our partners in the development and manufacturing of gene therapies. Our world-class, cGMP manufacturing facility is purpose-designed for viral vector manufacture. Our experience coupled with state-of-the-art analytical and manufacturing technologies ensures we design, develop and deliver high quality, approvable gene therapies.

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Services

  • Targeted process development using best-in-class analytics to drive scale-up to cGMP
    • Single-use technology
    • Suspension-based cell culture
    • Serotype dependent toolbox approach to downstream
      processing
    • Chromatography-based purification solutions
    • Automated and high-throughput development platforms
  • Starting material production, management and release
  • Phase-appropriate method validation and method transfer
  • Advanced analytical toolkit for process & product characterisation
  • Rapid transition from development to clinical manufacture, utilising Pharmaron’s established platform processes and multi-skilled process sciences team
  • Effective scale-up and technical transfer to one of our GMP viral vector suites
  • Quality assurance and qualified person batch release
  • On-site cryo storage

Capabilities

  • Scalable suspension culture systems
  • Range of GMP bioreactor scales (50L to 500L)
  • Single-use technologies
  • Chromatography-based purification
  • Purification by ultracentrifugation available
  • Comprehensive analytical toolkit
  • Unique viral vector characterisation analytics
  • Dedicated QC analytical capabilities

 

 

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