Lonza Expands Capabilities for Parenteral Dosage Forms

• Operational since November 2016, new expansion triples floor space and further increases number of staff
• Expansion adds new capabilities and enhances existing service offering
• Together with its expertise in oral solids, Lonza will be able to provide high-end solutions for both oral and parenteral dosage forms

Basel (CH), 5 November 2018 – Lonza announced today that its Pharma & Biotech segment has expanded its footprint for parenteral dosage form development with a further build-out of its Drug Product Services (DPS).

In response to market demand, this latest investment significantly increases both capability and capacity of DPS at the Stücki Science Park in Basel (CH). Lonza is also nearing completion of its recruitment that will extend the DPS group to 125 staff.

The expanded offering includes new capabilities for:

• Clinical administration and compatibility testing
• Lyophilization cycle and process development and robustness testing
• Containment for highly potent and BSL2 drug product handling, enabling formulation and drug product development of highly potent conjugates, viruses, cell therapies and small-molecule parenteral preparations
• Aseptic manufacture of liquid/lyophilizate dosage forms for stability and pre-clinical studies
• Lifecycle management line extension
• Bioassay (cell- and ELISA-based)
• Device functionality testing

DPS opened its laboratories in November 2016 with an initial focus on formulation development, drug product analytics and QC, and special drug product services. The facility was granted a GMP license in June 2017 after a successful audit by Swissmedic, which allowed QC release and stability testing of drug products for clinical and commercial use. Since opening, two years ago, Lonza DPS has developed solutions for 88 molecules for 57 customers; and it complements Lonza's extensive service offering in biologics with end-to-end capabilities.

“Including drug product services in the portfolio provides our customers with a single supplier for their clinical outsourcing requirements,” said Karen Fallen, Senior Vice President and Head of Clinical Development and Manufacturing, Lonza Pharma & Biotech. “DPS customers recognize our commitment to their challenges. We have built an experienced team with the ability to solve problems based on scientific, industry and regulatory know-how.”

About Lonza Drug Product Services

The DPS team provides a holistic approach to drug product development that anticipates and prevents problems early and helps ensure the product is optimal for manufacture, supply chain and patient use. The DPS team provides a complete portfolio of services for parenteral dosage forms including products for injection and infusion for intravenous, subcutaneous, and intraocular routes of administration. These offerings also include specialized services, such as:

• Particulate identification, characterization and quantification
• Excipient and surfactant characterization
• Extractables and leachables assessment
• Container closure integrity testing

Based on more than 30 years of experience in biopharma drug substance development, our integrated gene-to-drug product offering accelerates and de-risks pharmaceutical product development and commercialization.