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Process Development and Validation

Your processes will be developed, optimized, and prepared for clinical and commercial production at our state-of-the-art research and development centers in Regensburg (ResCom®), Germany and Linz, Austria. In addition to the full range of standard process development technologies, we have capabilities for high throughput experimentation. There are also complete in-house analytical labs for in-time testing. Most importantly, both facilities are staffed by a team of experts with many years of experience.

Core competences of the Patheon process development team include:

  • Route scouting
  • Development batches
  • Clinical trial materials
  • Scale-up of new and existing manufacturing processes
  • Transfer and implementation of new processes coming from customers and implementation of internal manufacturing processes
  • Troubleshooting of development issues
  • Improvement of existing manufacturing processes
  • Expertise with difficult to manufacture APIs
  • High potency compounds and controlled substances

Chemical Development Capabilities:

  • Generation of comprehensive Development Plan
  • Chemistry evaluations
  • Mechanistic and kinetic studies
  • Reaction parameter optimization
  • Experimental design
  • Critical process parameters and quality attributes
  • Process sensitivity studies
  • Waste minimization and solvent recycling
  • Raw material supplier evaluations and qualifications
  • Cleaning procedures
  • Evaluation of solid state drug substances
    • Micromeritics
    • Solvation
    • Crystal habit
    • Polymorphism
    • Physical handling

Chemical Engineering Capabilities

  • Technical evaluations
  • Hazard evaluations
  • Critical process parameters and quality attributes
  • Proven acceptable ranges (PAR)
  • Waste minimization and solvent recycling
  • Critical process parameters and quality attributes
  • Process sensitivity studies
  • Waste minimization and solvent recycling
  • Environmental and industrial hygiene assessment
  • Optimization of unit operations and process controls
  • Equipment configuration and construction material evaluations
  • Final process definition
  • Evaluation of solid state drug substances
    • Micromeritics
    • Solvation
    • Crystal habit
    • Polymorphism
    • Physical handling

Once your process is developed, it will be scaled-up for production. This includes risk assessments, proven acceptable range (PAR) studies and validation of analytical methods and the manufacturing process. If needed, our QA / regulatory compliance team can provide all the data and support you need for the CMC portion of your submission.

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