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Formulation Development Services
FromCELONIC Group
ProJect Pharmaceutics* builds quality into formulation and processes and applies high-throughput predictive stability technologies (Predictive Formulation Analytics, PFA) to ensure manufacturing consistency. Using such a regulatory-compliant Quality by Design (QbD) step at an early stage will result in an accelerated and risk-mediated downstream process (DSP) development. It will also generate a more stable final drug substance formulation that, ideally, results in a consistent formulation for drug substances and products.
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- Quick identification of protein’s likes/dislikes (comfort zone) based on basic formulation profiling
- Optimized yield based on rationale design of stabilization concepts per DSP step within identified comfort zones
- Minimized aggregation tendency, even at high concentrations, based on rationale UF/DF development
- Accelerated drug product formulation based on thorough DSP groundwork
*A sister company of Celonic