Lonza Basel, Switzerland

About Lonza:

Lonza offers broad capabilities which span across biologics, small molecules, bioconjugates, and cell and gene therapies, and capsules & health ingredients. Lonza manages projects from the pre-clinical stage through to commercialization, and their capabilities cover both drug substance and drug product.

Service Offerings:

• Biologics formulation development capabilities
• Development of Target Product Profile (TPP)
• Formulatability studies
• Early-stage formulation development
• Late-stage and commercial formulation development
• Formulation of drug product for different parenteral administration routes (e.g. intravenous. subcutaneous. intramuscular. intravitreal or intrathecal injection)
• Highly concentrated protein solutions formulation
• Formulation development for multi-dose preparations
• Preclinical and clinical simulated in-use stability and compatibility testing
• GMP drug product manufacturing of biologics or small molecules
• Primary packaging development and qualification
• Tech transfer
• GMP manufacturing as liquid or lyophilizate
• GMP manufacturing for highly potent compounds
• Investigation support Extractables and leachable
• Subvisible and submicron particle characterization
• Particle identification
• Packaging and device characterization (surface morphology. computer tomography)
• Higher-Order Structure & Comparability
• Drug/Device combination product functionality testing
• Small molecule formulation development and expertise
• Development of Target Product Profile (TPP)
• Solubility testing and Solubilization screening
• Pre-formulation
• In silico pre-formulation
• Early-stage formulation development
• Late-stage and Commercial formulation development
• Formulation robustness testing
• Life-Cycle management and Line Extension formulations
• In-use stability
• Compatibility testing
• Formulation Compatibility testing (Hemolysis )

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