Basel, Switzerland

Parenteral drug product services

The Drug Product Services group is located in Basel, Switzerland with state-of-the-art analytical, formulation and drug product processing equipment, and unparalleled expertise in parenteral drug product development, manufacturing and testing.

Our DPS activities are performed in Basel, Switzerland. Drug product development services are based in a 3000 m² facility in the Stücki Technology Park Basel. 

The site focuses on formulation and drug product process development, drug product analytical development and quality control. Specialized services are available for particulate identification, characterization and quantification, excipient and surfactant characterization, extractables and leachables assessment, product comparability and testing of container closure integrity and drug/device combination products.

The DPS Team is highly skilled in the development, manufacture and analysis of parenteral formulations and finished drug products for injection, infusion or implant of a variety of product types and molecules. The drug product analytical development and quality control (QC) group has industry-leading technical, scientific and regulatory expertise in method development, product characterization and testing of biopharmaceuticals and parenteral small molecule formulations.

Technologies and products

Biologics formulation development capabilities and expertise

• Development of Target Product Profile (TPP)
• Formulatability studies
• Early stage formulation development
• Late stage and commercial formulation development
• Formulation robustness studies
• Formulation of drug product for different parenteral administration routes (e.g. intravenous, subcutaneous, intramuscular, intravitreal or intrathecal injection)
• Highly concentrated protein solutions formulation
• Rheological characterization and developing stable formulations for viscosity reduction
• Formulation development for multi-dose preparations
• Preclinical and clinical simulated in-use stability and compatibility testing
• Microbiological in-use time definition and testing
• Pharmacy manual and trainings

Process development capabilities and expertise

• Lyo cycle development
• Sterile filter sizing and selection
• Compatibility with contact material and hold time studies
• Pump selection and filling curve optimization
• Mixing parameters
• Freezing and thawing set-up and optimization
• Process characterisation and robustness studies
• Process validation

Non-GMP DP manufacturing for GLP tox and supportive stability studies

• Non-GMP manufacturing as liquid or lyophilisate
• Non-GMP manufacturing for highly potent compounds including ADCs

GMP drug product manufacturing of biologics or small molecules

• Primary packaging development and qualification 
• Tech transfer
• GMP manufacturing as liquid or lyophilisate
• GMP manufacturing for highly potent compounds
• Investigation support

Special services and expertise

• Extractables and leachables
• Subvisible and submicron particle characterization
• Particle identification
• Packaging and device characterization (surface morphology, computer tomography)
• Characterization, Higher Order Structure and Comparability
• Drug/Device combination product functionality testing 

Small molecule formulation development and expertise

• Development of Target Product Profile (TPP)
• Solubility testing and Solubilisation screening
• Preformulation, in silico preformulation 
• Early-stage formulation development
• Late-stage and Commercial formulation development
• Formulation robustness testing
• Life-Cycle management and Line Extension formulations
• In-use stability and compatibility testing 
• Formulation Compatibility testing (e.g., Hemolysis )
• Stability (autoclavability, Arrhenius, alternative sterilization methods).

Quality systems and regulatory inspections

Basel operates under the global quality management system which complies with internal policies as well as with national and international regulations. Since receiving the GMP certificate in 2017, Lonza Drug Product Services has had multiple successful inspections from health authorities, in addition to successful customer and self-inspections.