Pilot and Commercial Scale Manufacturing

Accelerating, transforming challenge into success

Manufacturing Facilities

Scale Up and cost effective China manufacturing operations, summarized as follows:
  • Two active RSM & GMP Intermediate approved China manufacturing facilities for late-stage development and commercial production
  • Highly flexible, multi-purpose production capacity
  • Staff of 130, including highly skilled chemists, production operators, QA and QC teams.  
  • cGMP-like Kilolabs for Early Phase Delivery
  • Pilot and commercial production vessels from 50L to 5000L
  • Operating Temperature Range – 80°C To + 250°C
  • Highly skilled in lengthy multi-step chemistry, hazardous reactions, sensitive processes
  • Experienced Quality Assurance professionals team following Q7A principles
  • Well trained QC analytical chemists to release in-coming raw materials, perform in-process assays and to release intermediates and API as well as develop and validate methods used during production.
  • Batch records are prepared specifically for each individual project and provided upon request.
  • One additional commercial production site currently under construction. Upon completion, 523m3 of new RSM & cGMP production volume capacity and staff of 300 will be added