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Pilot Scale Production

A sterile and modern biomanufacturing lab with stainless steel fermentation tanks, control units, and various interconnected tubes and cables. The setup is well-organized and clean, indicating a controlled environment for bioanalytical development or pharmaceutical processes.

Pharmaron has established a dedicated non-GMP pilot-scale production facility with floor areas of more than 10,000 ft2.  The facility has been equipped with two 200L single-use fed-batch production lines, one downstream purification line and non-GMP product filling capabilities.

  • IND-enabling toxicology study material production
  • Process scale-up studies
  • Technology transfer support
  • Non-GMP batch production to meet NMPA filing requirements for process consistency and scalability
  • Process characterization studies

Capabilities

Developability Assessment
Process Development
Analytical Development and Quality Control
Pilot Scale Production
cGMP Drug Substance Manufacturing
cGMP Drug Product Manufacturing
Quality Assurance
purple abstract design

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