With over 25 years of experience in successfully developing numerous lyophilized products, including more than twenty commercial products, Dr. Kamat is widely considered as a proven expert in lyophilization technology. Under his supervision, we offer comprehensive and practical assistance in all aspects of development of lyophilized products and processes to our clients. We provide lyophilization support for small molecules as well as biologicals in a variety of dosage forms. 

Formulation Development

Formulation Development: Small Molecules and Biologicals/Proteins

  • Pre-formulation Studies
  • Rational Selection of Excipients and Product Design
  • Process Development
  • Diluent/Compatability Studies

Methods Development: Identifying Critical Quality Attributes (CQAs)

  • Frozen material: Thermal Analysis to Determine Critical Temperatures.
  • Final product: Moisture Determination (KF), Visual Inspection, Reconsititution Studies, Chemical Tests

Container Closure: Vials/Syringes/Ampules

  • Selection and Characterization of Packaging Components
  • Glass Studies
  • Container Closure Integrity Testing (CCIT)

Lyophilization Cycle Design and Optimization

  • Cycle Process Development
  • Dual-Chamber Syringe/Cartridge Freeze-Drying
  • Non-aqueous Lyophilization for Water-insoluble Drugs

Manufacturing Support

  • Scale-up and Transfer from Laboratory to Commercial
  • Process Validation
  • QbD Experimentation
  • Bulk Freeze Drying in Trays
  • Controlled Nucleation
  • Remote Temperature Sensing
  • Organic Solvents and Non-aqueous Systems

Supply of Materials

  • Toxicological Samples
  • Stability Sample Manufacturing and Storage
  • Analytical Reference Standards
  • Biological Materials: Bacteria, Enzymes, Food, Reagents

Regulatory Support

  • Consultancy for CMC Issues
  • Regulatory Compliance
  • Regulatory Filing Support: US and International
  • QbD Principles Implementation
  • Support in Plant Inspectional Observations and Corrective Actions