Lonza To Launch Parenteral Drug Product Services
Lonza plans to expand its pharmaceutical and biotechnology segment by offering development and manufacturing services for clinical outsourcing of drug products. 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 Prof. Dr. Hanns-Christian Mahler, who for 10 years led the departments of Pharmaceutical Development & Supplies and Formulation R&D Biologics for Roche. His work experience in this field includes early- and late-stage formulation development, primary packaging and device development, drug product process development, process characterization and validation, protein analytics and drug product cGMP manufacturing.