Flexible modeling for process design and scale-up

PAS-X Process Development solution

PAS-X Process Development simplifies and speeds up the modeling of manufacturing processes for pre-clinical and clinical production. It is available as an entry-level solution or an integrated business function of the PAS-X MES.

Sales

Shawn Opatka

Phone: +1 973 646-3408

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Goals and drivers

Business

  • Accelerated and enhanced MBR development, MBR validation and batch record review
  • High process visibility due to a single system for all stages
  • Agile response to changing clinical trials demands
  • High flexibility while maintaining GMP-compliant status

Knowledge transfer

  • Simplified transfer of processes from development stage to commercial production using structured information
  • Supporting an open, flexible approach for development of technical batches
  • Collection of all GMP-relevant data
  • Predefined library elements to accelerate scale-up process ensuring flexibility and observing compliance requirements
  • Supporting a collaborative approach
  • Allowing on-the-fly definition of the batch record structure at early development stages

Process development

  • Design of Experiments (DoE) features to identify Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) to enable Quality by Design (QbD)

Why PAS-X Process Development

  • Fast and flexible MBR development
  • High degree of flexibility in early-stage batch recording
  • DoE approach for CPP and CQA identification to enable QbD
  • Improved process visibility, data analysis and information transfer