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
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