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Confidence Beyond Compliance
PharmaLex has many years experience in proposing robust and innovative statistical solutions for the development, validation and control of processes, in particular bio-processes for mABs, vaccines and cell cultures. Combined with expertise in analytics, PharmaLex ensures that the robustness of (bio) processes is guaranteed.
Our services include:
Lifecycle and Quality by Design methodology
- Strategies for stage 1, stage 2 and stage 3
- Advanced Design of Experiments (DoE)
- Computation of multi criteria Design Space
- CPV
- Robustness metrics and predictive capability
- Statistical Process control
- Strategies and report of transfer
- Optimization and modeling of scale-up scale-down
- Definition of specifications
- Development and implementation of PAT methodologies
Continuous manufacturing
- Setup and justification of sampling plan
- Development and implementation of PAT
- Methodologies for release testing
- Assessment of content uniformity
Stability
- Design of optimized stability studies
- Computation of shelf-life
- Internal Release Limits for linear and non-linear degradation
- Accelerated modeling and prediction
Formulation
- Specialized Design such as mixtures design
- Advanced Modeling for optimization
- Combined prediction with stability assessment
