Lonza Expands Parenteral Dosage Form Capabilities
The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.
Lonza announced on Nov. 5, 2018 that its Pharma & Biotech segment has expanded its footprint for parenteral dosage form development by further building out its drug product services (DPS) at its facility in Stücki Science Park, Basel, Switzerland.
In response to market demand, this latest investment significantly increases both its DPS capability and capacity. The company is also nearing completion of recruitment that will extend the DPS group to 125 staff.
The expanded offering includes new capabilities for:
- Clinical administration and compatibility testing
- Lyophilization cycle, process development, and robustness testing
- Containment for highly potent and biosafety level 2 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 enzyme-linked immunosorbent assay-based)
- Device functionality testing.
DPS opened its laboratories in November 2016 with an initial focus on formulation development, drug product analytics and quality control (QC), and special drug product services. The facility was granted a GMP license in June 2017 after an audit by Swissmedic, which allowed QC release and stability testing of drug products for clinical and commercial use. Lonza DPS has since 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, in a company press release. “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.”
Source: Lonza
