Process Development and Engineering

Process development and engineering support for new projects, trouble shooting and solutions for existing processes and unit operations. We can provide process development engineering from initial concept and laboratory demonstration to technology transfer into full scale manufacturing and start up support.

Services Include

  • Troubleshooting and problem solving for equipment, processes, and work flow
  • Optimization and scale-up of existing processes, including evaluations of cycle time, yield, quality, and unit operations
  • Statistical assessments 
  • Procedures for manufacturing operations and equipment cleaning to meet requirements of manufacturing, quality, regulatory, environmental, safety, and industrial hygiene
  • Feasibility studies / conceptual design / facility fit
  • Analysis of throughput in multiple plants or same-site train locations
  • Mass & energy balances, process flow diagrams (PFDs), and piping & instrumentation diagram (P&ID) development
  • Technology transfer and start-up support from lab to pilot to large scale
  • Hands-on and research-based engineering development at laboratory scale for reactions, actual mass balances, and unit operations including:
    • raw material handling and charging
    • reactions and separations
    • final product isolation & packaging
  • Support for in-house development, including testing protocols, data collection and laboratory analysis
  • Documentation support for regulatory filings for new drug applications (NDA)
Representative Projects

  • Filtration optimization to improve full scale yield worth $1.7M annually
  • Innovative material handling procedure to reduce project cost by $2.4M and reduce operator exposure of highly hazardous product (presented at ISPE)
  • $500K reduction in project cost through statistical data analysis
  • Design and implementation of solvent recovery to increase recovery by 18% (worth $2.3M/month)