Access a range of models for each unit operation of parenteral drug product manufacturing We can evaluate different unit operation parameter for its criticality based on risk assessments, and subject critical process parameters to study for potential impact on relevant product-quality parameters (including critical quality attributes).
We can support you in the early and late-stage formulation and dosage form decisions. You may need lyophilization or freeze-drying to stabilize a product against degradation that would otherwise occur in a liquid state to an unacceptable degree. Especially for late-stage development and intended commercialization, lyophilization cycle development and scale-up ensure a cost-effective manufacturing process that guarantees product critical quality attributes and maintains a low rejection rate. Our experts use the latest modeling techniques combined with PAT tooling to evaluate the optimal lyo cycle process and ensure a smooth upscaling and technical transfer to manufacturing sites.
Deviations are not uncommon during manufacturing, and root-cause investigations (RCIs) are necessary to identify the underlying causes, followed by putting the correct corrective and preventive actions in place. Our experts can support with a wide variety of challenges that may be encountered during development and/or drug product manufacture.
Our locations
Location where this service is provided
Basel, Stücki Technology Park, Switzerland
The Drug Product Services (DPS) 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.
The DPS team is highly experienced 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 group has industry-leading technical, scientific and regulatory expertise in method development, product characterization and testing of biopharmaceuticals and parenteral small molecule formulations.
