Technician testing a sample in biosafety cabinet

Reach Our ADC Experts:

adc@lonza.com

Antibody Drug Conjugate (ADC) manufacturing is demanding and requires focus and extensive expertise.  The safety requirements for ADC development and production are stringent and different from conventional small molecule production.  For safe and effective ADC manufacturing, the environment must be designed to protect not only personnel from exposure to cytotoxic substances but also must maintain an aseptic processing environment.  Lonza meets industry standards for the safe handling of highly potent active pharmaceutical ingredients in ADC operations.

Lonza’s Quality Control Capabilities for ADC Manufacturing:

  • QC team / labs dedicated to ADC production
  • Method development
  • Method transfer and validation
  • Raw material testing
  • In-process testing (24/7), PAT
  • Cleaning (swab / rinse by TOC; conductivity)
  • Stability testing
  • Environmental monitoring
  • Quality Control Methods
  • HPLC /UPLC, LC-MS, GC
  • CE
  • UV, IMS
  • Bioassay (enzyme and protein assays)
  • ELISA
  • SDS-PAGE / PAGE
  • Western blot testing
  • Microbiology (Bioburden, Endotoxins)
  • Karl-Fischer titration units
  • Osmolality
  • Turbidity

 

Lonza strives to set future industry standards of safety by focusing on health and the environment throughout the production process:

  • Cleaning-in-place (CIP)
  • Steaming-in-place (SIP)
  • Water for Injection (WFI)
  • Area classification
  • Gowning requirements
  • Dedicated and well-trained staff
  • Validated cleaning procedures
  • Safe-change air filters
  • On-site incineration for disposables
  • Aseptic operation experience
  • Scalable equipment
  • GMP clinical ADC batches released with high success rates
  • GMP suites for clinical supply (50-150g)