lab glasses

Reach Our Drug Product Services Experts:

drugproduct@lonza.com

Lonza’s Drug Product Services team is highly skilled in the development of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates, and vaccines, as well as viral- and cell-based therapies.

Formulation development services are available for liquid and lyophilized drug product dosage forms and are performed integrating relevant container closure systems such as vials, stoppers and caps or syringes and appropriate drug product process manufacturing designs.


The service offerings comprise the complete array of development activities:

  • Pre-formulation, developability, and candidate selection support
  • Early stage formulation development
  • Late phase formulation and process development
  • Container-closure system selection and qualification
  • Rapid automated high-throughput formulation screening
  • In-use stability (simulated administration testing)
  • Manufacturing of pre-clinical GLP drug product (e.g. toxicology testing)
  • Long-term and accelerated drug product stability studies according to ICH guidelines
  • Drug product manufacturing process setup and design, selection of unit operations and process ranges, selection of processing materials such as disposable tubing and filters and process development and characterization
  • Technical transfer and scale-up support for clinical and commercial drug product manufacturing
  • Regulatory support for Drug Product sections IND/IMPD, BLA/MAA documentation

Special expertise is provided for:

  • Surfactant characterization
  • Ocular delivery and related requirements
  • Highly concentrated protein formulation and products for subcutaneous administration
  • Container closure system requirements, design and qualification
  • Quality-by-Design (QbD)
  • Breakthrough Therapy submissions

 

The Drug Product Services team works closely with the Drug Substance sites across the Lonza network enabling an integrated and high quality One-Stop-Shop from a single service provider.

All services are available as standalone services.