These drug product services will focus on parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous, intraocular and other routes of parenteral administration. Services will include options for monoclonal antibodies, other biologics, drug conjugates, peptides and small molecules that require a parenteral dosage form.
Drug product services will be offered in the fourth quarter of 2016 from laboratories based in Basel, Switzerland with an initial focus on formulation development and drug product analytical development and quality control. Specialized services will also be available for customers, such as particulate identification, characterization and quantification, excipient and surfactant characterization, extractables and leachables assessment and testing of container closure integrity. Drug product manufacturing capabilities for preclinical and clinical use (cGMP) will be available in late 2016.
Heading the drug product business is Hanns-Christian Mahler, who for 10 years led the departments of pharmaceutical development and supplies and formulation R&D biologics for Roche.
“Expansion of our portfolio into drug product services fits well with our existing and future customers’ needs and is an important step in becoming a one-stop-shop for all clinical outsourcing requirements,” said Marc Funk, chief operating officer, Lonza. “Beginning with our GS and XS Gene Expression Technologies, continuing with cell line construction, process and analytical development through to clinical supply, our new drug product services team enables Lonza to provide world-class services.”