Lonza expands capabilities with drug product development services
The firm aims to become a one-stop shop for all clinical outsourcing requirements
Lonza is expanding its Pharma&Biotech business by entering into drug product services to offer a complete portfolio of development and manufacturing activities for clinical outsourcing.
The service will focus on parenteral dosage forms for biologics, drug conjugates, peptides and small molecules for products for injection or infusion.
The service will be offered from the fourth quarter of this year from the Swiss firm's laboratories in Basel, with an initial focus on formulation development and drug product analytical development, in addition to quality control.
Specialised services such as particulate identification, characterisation and quantification, excipient and surfactant characterisation, extractables & leachables assessment and testing of container closure integrity will also be included.
Drug product manufacturing capabilities for preclinical and clinical use (cGMP) will be available in late 2016, the firm said.
The expansion into drug product services is an important step in Lonza becoming a one-stop-shop for all clinical outsourcing requirements
Heading the drug product business is Professor Hanns-Christian Mahler, who for 10 years led the Pharmaceutical Development & Supplies and Formulation R&D Biologics departments at Roche. His experience in this field includes early- and late-stage formulation development, primary packaging and device development, drug product process development, process characterisation and validation, protein analytics and drug product cGMP manufacturing. He also has a track record in successful regulatory filings, including INDs/IMPDs and BLAs/MAAs.
Prof. Mahler is building a drug product services team with experience in formulation development, drug product process development, drug product analytics and cGMP manufacturing. This new team will provide services for parenteral dosage forms for several drug classes.
Marc Funk, COO of Lonza, said the expansion into drug product services is an important step in Lonza becoming a one-stop-shop for all clinical outsourcing requirements.
'Beginning with our GSTM and XSTM 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,' he said.
