Ensure comparable product quality and safety with phase-appropriate process development
The drug product manufacturing process involves several unit operations, which have significant impact on the drug product quality, if not carefully chosen. Our experts will evaluate instruments and material of contact for their suitability/compatibility, and identify critical process parameter.
Process characterization and robustness testing
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).
Lyophilisation cycle development, scale-up and robustness
We can support you in the early and late-stage formulation and dosage form decisions. You may need Lyophilisation 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, Lyophilisation cycle development and scale-up ensure a cost-effective manufacturing process that guarantees the product critical quality attributes and maintains a low rejection rate. Our experts use the latest modelling techniques combined with PAT tooling to evaluate the optimal lyo cycle process and ensure a smooth up-scaling and technical transfer to manufacturing sites.
Process validation transfers and design
We will help you manage successful process transfers to ensure overall manufacturing success. Each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes.
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.