CMC: The chemistry, manufacturing and controls (CMC) process plays an integral role in the success of a therapeutic compound.

The CMC Process:  The ability to assure, over time, the physical and chemical properties of an active pharmaceutical ingredient, drug product or nutraceutical is critical for regulatory approval and therapeutic success. The CMC process is necessary for an efficient and comprehensive development strategy. The major challenge for the manufacturing and control component of drug development is to assure the chemical and physical properties of the compound and product are monitored at all critical phases of the pathway.

The development of new pharmaceutical products and their manufacturing processes typically goes through the following formal stages of product/process development:

Product/Process Development Stages:

• Preformulation Studies
• Product Design and Development
• Process Development & Preparation of Clinical & Bio-batches
• Process Scale-up & Evaluation
• Formal Prospective Process Validation
• Production & Retrospective Validation

Product/Process Development Services that can be outsourced on CanBiotech include:

Process Development
  Analytical Methods
  Formulation
  Process Development
  Scale-up

Manufacturing
  Manufacturing, Clinical
  Manufacturing, Commercial
  Manufacturing, Preclinical
  Manufacturing, Product Registration

Packaging
  Aerosol Filling
  Delivery System
  Design and Testing
  Encapsulation
  Sterile Filling
  Storage
  Syringe Filling
  Tableting

Quality Assurance and Control
  Cleaning and Monitoring
  Compliance Audits
  Equipment Validation
  Facilities Design/Construction
  ISO
  QA Development