Lonza announced that its Pharma&Biotech segment is expanding its footprint to offer customers a complete portfolio of development and manufacturing services for clinical outsourcing requirements by entering into Drug Product Services. This new service offering is part of Lonza’s drive to enable customers to meet some of the greatest challenges in patient treatment. 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 (CH), 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 & 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 extensive 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. He also has a strong track record in successful regulatory filings, including INDs/IMPDs and BLAs/MAAs.
Prof. Mahler is building a Drug Product Services team that has exceptional industry experience in Formulation Development, Drug Product process development, Drug Product Analytics and cGMP manufacturing. This new team will provide best-in-class services for parenteral dosage forms for several drug classes.
“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, COO of 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.“