Specialty Chem Manufacturing

Ricerca has a broad range of Specialty Chemical Manufacturing capabilities to suit your needs. From small batch scale up to larger batch manufacturing, our Process Engineers and Chemists have manufactured complicated industrial products serving the specialty chem market.

Ricerca offers first–class analytical chemistry, synthetic chemistry, engineering, radiochemical synthesis, and chemical manufacturing services that are designed to meet your needs throughout all phases of product development. Our highly experienced scientific team has a proven history of achievement with complex chemistry challenges and provides a complete solution for your specialtychem product development needs.

Ricerca’s analytical chemistry services include:

  • Salt, polymorph & co–crystal screening
  • API drug substance & drug product method development & validation
  • Impurity identification & structural elucidation
  • Impurity isolation & synthesis
  • Materials characterization & release testing
  • Dose formulation analysis
  • Stability programs
  • Radiochemical analysis
  • Extractable and leachable programs

Ricerca’s synthetic chemistry services include:

  • Process research and route selection
  • Radiochemistry synthesis (non–GMP and cGMP)
  • Stable labeling synthesis
  • Metabolite/degradant identification and synthesis
  • Process optimization
  • Robustness and process limits testing
  • Process justification
  • Synthesis of analytical reference standards
  • Preparation of cGMP–grade API for preclinical and clinical needs

Process chemistry

  • Route discovery and definition
  • Process improvement and optimization
  • Robustness and process limits testing

Process development and engineering

  • Process scale up and demonstration
  • Process validation
  • Engineering data acquisition
  • Technology transfer to commercial scale

Manufacturing

  • Preparation of active pharmaceutical ingredients (APIs) under cGMP controls
  • Preparation of intermediates, regulatory starting materials and performance chemicals
  • Multi–kilogram to multi–ton amounts (process–dependent)
  • Manufacturing in support of pre–clinical, clinical and commercial requirements