Formulation and drug product process development, drug product analytical development and quality control
Our drug product services (DPS) team has deep expertise 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.
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.
Biologics formulation development capabilities and expertise
- Development of Target Product Profile (TPP)
- Formulatability studies
- Formulation of drug product for different parenteral administration routes (e.g. intravenous, subcutaneous, intramuscular, intravitreal or intrathecal injection)
- Early stage formulation development
- Late stage and commercial formulation development
- Formulation robustness studies
- High-concentration formulations
- 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
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, our drug product services have had multiple successful inspections from health authorities, in addition to successful customer and self-inspections.