We drive our customer’s development projects

A thoroughly crafted CMC strategy is vital to navigate your projects through the various development stages without losing sight of the important elements.

In our assessments, we not only provide a tailored process development plan but also evaluate sourcing of adequate starting materials, include analytical, formulation, stability aspects and account for regulatory and quality compliance. With our CMC roadmaps, we significantly elevate your chances of success, guiding you seamlessly from conception to market launch.

We are committed to Quality by Design (QbD) principles, fostering comprehensive process understanding, regulatory compliance, and exceptional product quality. We support implementation of these principles, definition of (quality) target product profiles, and identification of critical quality attributes as well as associated process parameters. Ultimately, we translate our findings into a phase appropriate process control strategy.

From defining individual unit operations to developing complete upstream, downstream, or end-to-end manufacturing processes, our focus remains on enhancing process efficiency while ensuring scalability and robustness. We develop a streamlined process to bring your product candidate to clinical proof-of concept and beyond.

By refining and optimizing your existing manufacturing procedures we deliver scalable and robust processes primed for commercial success.

Establishing tailored scale-down models, we support process characterization activities of your late-stage development project, providing valuable insights for process performance qualification (PPQ).

By employing advanced biological and biochemical assays, we precisely measure product titers and analyze product impurities to refine production processes to perfection.

Using state-of-the-art biophysical methodologies, we characterize viral particles, including particle size distribution and aggregation status. For AAV-specific projects we are able to distinguish between full and empty particles and assess optimal transgene delivery.

Harnessing cutting-edge Process Analytical Technology (PAT) tools, we enable real-time monitoring and fine-tuning of every production aspect, enhancing both efficiency and quality control.

Ultimately, our comprehensive range of analytical services includes strategic planning for product release and characterization, ensuring adherence to regulatory standards and quality benchmarks.