GMP Production 2017-09-22T13:16:43+08:00

GMP Production

Amaran has excellent capabilities in providing process development, manufacturing, and analytical services for protein product. Amaran has experience and knowledge in standards appropriate to developing and manufacturing APIs.

Unique Manufacturing Capacities

  • Carbohydrate Synthesis, Ozonolysis, Thiolation & Conjugation of Protein
  • Protein Purification with High Pressure Columns (Chromatography)
  • Lyophilization

Compliance Capacities

  • Strong commitment to cGMP to comply with FDA, EU and PIC/S guidelines
  • Support “Common Technical Documents” (CTD) for NDA or ANDA

Analytical Capabilities

  • Analytical Methods Development & Validation: Identification, Quantification, Potency, Impurities, Biological study
  • Microbiological testing capabilities
  • Stability Studies using ICH standards

Project Management

  • Project Manager dedicated full-time and responsible
  • Customers’ extended arms in the plant
  • Regular teleconferences with customers
  • Leader of Project Management Program Reports to highest level committee
  • Extensive training program

Protecting the Environment

  • Amaran is fully committed to Responsible Care Program
  • Amaran complies with the international Environmental Health & Safety Standards for employees and environmental protection
  • High potency waste products are identified for specialized containment and appropriate treatment for all gaseous, liquid and solid emissions.

GMP Status

  • TFDA PIC/s GMP inspected and qualified
  • GMP quality system is in place
  • Quality system is compliance with TFDA, US FDA.
  • Flexible GMP system for early RD operation and clinic supply