SERVICES

Step 1

PROCESS DEVELOPMENT

In addition to enzymes, our team has supported development programs during scale up and manufacture of proteins, antibody fragments and carbohydrates.

Step 2

PROCESS TRANSFER

Process Transfer follows four steps:

  1. Feasibility (technical and commercial)
  2. Process Transfer, which covers reproducing the current process, focusing on critical control points
  3. Process Development, including Design of Experiment (DOE), upstream and downstream optimization, and Pilot production
  4. Commercial Manufacture, which addresses Engineering, Validation, and Quality Assurance requirements
Step 3

CONTRACT MANUFACTURING

Our facilities and expertise include world-class fermentation based manufacturing, along with fully integrated Research and Development, Quality and Engineering.

Step 4

QUALITY EXCELLENCE

Committed to operating to the highest quality standards.

  • Compliant with ISO 9001 all operations certified
  • OHSAS 18001 Safety Management System
  • ISO 14001 Environmental Management System
  • FDA 21 CFR 820.30 GMP operations available for therapeutic manufacturing
  • ISO13485 plus other controlled processes (suitable for Biopharma processing)