Analytical Development and Quality Control

Pharmaron’s biologics analytical development team provides both platform and bespoke physicochemical and biological characterization, as well as method services (development, optimization and qualification/validation).  Our team has a wide range of antibody, protein and peptide experience and can support biologics development projects of various protein-based modalities.

  • Molecule Characterization – Analytical and biological characterization with respect to physicochemical property and potency, from early-stage molecules to development-stage products
  • Method Development – Physicochemical method and bioassay development, optimization, qualification/validation, transfer and trouble-shooting and maintain method lifecycle management (following ICH guidelines)
  • Process and Manufacturing Support – Comprehensive set of analytical studies to understand process capability (e.g., support PC and PV) and manufacturing trouble-shooting
  • CQAs and Control Systems – Defining product CQAs and the control system (e.g., specifications and stability shelf-life) for GMP manufacturing per client needs
  • Data Package and Report – Technical reports to meet client needs and generate IND-enabling analytical data package in support of relevant CTD sections in the regulatory filings
  • Flexible Service – Integrated analytical service packages and standalone services

Quality Assurance

  • Quality oversight to GMP operations, from materials, production to final product release
  • Perform GMP supplier audit and qualification, GMP training and documentation management, deviation and change control assessment, qualification and validation lifecycle management
  • Conduct internal audits to ensure appropriate GMP and compliance status are maintained throughout product development and GMP manufacturing life cycle.
  • Audit support for clients and assistance with site inspections
  • Internal support to project teams and ongoing training programs for all GMP employees to ensure policies, and SOPs are appropriately implemented and followed

Quality Management System (QMS)

  • QMS follows ICH Quality Guidelines and in alignment with current cGMP and global regulatory requirements adopted by the US FDA, NMPA, MHRA and EMA
  • Quality Manual and Policy, SOPs and Records/Forms form 3-tiered document structure hierarchy
  • E-system TrackWise is implemented to enhance the effectiveness of QMS during the execution