scientist hand holding a lab glass

Lonza’s Drug Product Services Team has technical expertise in analytical development & quality control (QC). The analytical development & QC team offers specialized contract laboratory services including:

  • Drug product non-GMP (R&D) and GMP (QC) release & stability testing
  • Submicron and subvisible particle characterization
  • Physical and chemical analytical laboratory services
  • Forensic chemistry including:
  • particle identification
  • extractable & leachable characterization
  • excipient (e.g. surfactant) degradant characterization

Drug product QC release and stability testing is supported by analytical method development and cGMP Drug Product stability testing according to ICH guidelines. The Drug Product QC Team can help to define shelf-life, specifications and develop a drug product control strategy for IND/IMPD or BLA/MAA, and design Quality-by-Design and Breakthrough therapy submissions.

The state-of-the-art particle lab is able to characterize submicron and subvisible particles using complementary methods covering the entire nano- and micro-particle ranges: DLS, SLS, AF4, NTA, RMM, CC, MFI, LO, SEM, and visual inspection. The particle lab can help design an adequate subvisible particle control strategy including specification setting to meet current health authority requirements and beyond.

The forensic chemistry group offers extractable/leachable studies for container closure systems and process & manufacturing equipment. The team has exceptional industry experience in the design and execution of drug product extractable/leachable control strategies and risk assessments. Together with the particle lab, the forensic chemistry group offers fast-track particle contamination root cause investigation in drug product processing and manufacturing.

For more information, please contact our Drug Product Services Experts at: