GMP Manufacture and QP Release

Two scientists in full protective gear manage a GMP (Good Manufacturing Practice) biomanufacturing process, monitoring a large stainless steel bioreactor. One operates a control panel while the other handles tubing connections, ensuring compliance for QP (Qualified Person) release. This process ensures product quality and safety before distribution.

GMP Manufacturing and QP Release Services

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 manufacture of gene therapy products.

Our world-class, cGMP manufacturing facility is purpose-designed for viral vector manufacture.  We have expertly trained cGMP staff consistently delivering drug substance to high quality standards with our ‘right first time’ approach.

A scientist in full protective gear operates a large biopharma manufacturing machine, ensuring GMP standards and quality control via a computer interface.

GMP Manufacture

  • Up to 500L scale bioreactors
  • Suspension-based cell culture
  • Chromatography-based purification solutions
  • Purpose-built manufacturing facility
  • State-of-the-art manufacturing scale validated equipment
  • Flexible and independent manufacturing suites
  • cGMP controlled warehouse
  • cGMP controlled cell bank storage facility
A scientist in full protective gear, including a hairnet and mask, operates equipment in a GMP manufacturing facility. They handle a large stainless steel vessel, ensuring compliance with sterile production protocols.

Services

  • Starting material production, management and release
  • Phase-appropriate method validation and method transfer
  • Advanced analytical toolkit for process & product characterization
  • Qualified and/or validated in-process monitoring and release testing for GMP release
  • Rapid transition from development to clinical manufacture, utilizing Pharmaron’s established platform processes and multi-skilled process sciences team
  • cGMP controlled storage of cell banks, raw materials and consumables
  • Effective scale-up and technical transfer to one of our GMP viral vector suites