Process Chemistry

Our experienced team of Ph.D. Process Chemists will work to develop your chemistry into robust and commercially viable processes. This veteran team has scaled-up and optimized hundreds of challenging chemical processes. The Process Chemistry group supports each other and works closely with the Manufacturing and Process Engineering teams to overcome chemical and engineering issues.

Their work is supported by a host of analytical tools, including a 400 MHz NMR, LC/MS, HPLC, UPLC, DSC, TGA, XPRD, etc. The Process Chemistry team also works closely with an outstanding Analytical Research team that is engaged at the onset of the development work allowing the Analytical Team to not only help support the Process Group, but will also allow them to take an early look at your molecule, which helps them develop robust analytical methods later.

Image Of Analytical Equipment Used In Regis Technologies Process Development Optimization
Pictured Regis Technologies Identification Of Impurity Profiles For Raw Materials Intermediates In The Commercial Process
Chemical Process Design

Process Development & Optimization

  • Route scouting
  • Process development
  • Optimization of yields
  • Reduction of high reaction dilutions
  • Elimination of hazardous reagents or intermediates
  • Thermochemical profiling by ARC, RC1 or DSC
  • Elimination of costly unit operations such as chromatography
  • Evaluation of safety concerns
  • Evaluation of new synthetic routes
  • Solid State Chemistry
  • Flow Reactor capabilities
  • Mettler-Toledo EasyMax Reactor Systems
  • Jacketed Reactor Systems
Process Development to

Process Validation

  • Stability data for intermediates and final API
  • Identification of impurity profiles for raw materials and intermediates in the commercial process
  • Fate & Purge of impurities
  • Evaluation of chemical processes for environmental health and safety issues
  • Identification of site specific needs for processing equipment including scale up issues
  • Determination of acceptable and failure limits to establish Critical Process Parameters
  • Stability data for intermediates and final API
  • Identification of appropriate storage conditions
  • Validation documentation
  • Raw material vendor qualification
Pictured Regis Technologies Identification Of Impurity Profiles For Raw Materials Intermediates In The Commercial Process
Chemical Process Design

Process Development & Optimization

  • Optimization of yields
  • Reduction of high reaction dilutions
  • Elimination of hazardous reagents or intermediates
  • Thermochemical profiling by RC1 or DSC
  • Elimination of costly unit operations such as chromatography
  • Evaluation of safety concerns
  • Evaluation of new synthetic routes
  • Flow Reactor capabilities
Image Of Analytical Equipment Used In Regis Technologies Process Development Optimization
Process Research to

Process Validation

  • Stability data for intermediates and final API
  • Identification of impurity profiles for raw materials and intermediates in the commercial process
  • Fate & Purge of impurities
  • Evaluation of chemical processes for environmental health and safety issues
  • Identification of site specific needs for processing equipment including scale up issues
  • Determination of acceptable and failure limits to establish Critical Process Parameters
  • Stability data for intermediates and final API
  • Identification of appropriate storage conditions
  • Validation documentation
  • Raw material vendor qualification

Request for Information

Rely on our expertise to accelerate your project from preclinical to commercialization, fast. Connect with our team and learn how we can help expedite your project to the next phase.







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