cGMP Manufacturing

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KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical, clinical and commercial supply.

KBI’s experienced team produces high quality therapeutics and vaccines through processes developed in-house or through processes transferred in from our clients.

GMP_200L-1-smOur state of the art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing for maximum flexibility and short turn-around times.

Our cell culture and microbial manufacturing facilities are fully separated including independent utility systems serving only their assigned production areas. Multiple HVAC zones, unidirectional flow of personnel and materials and strict environmental monitoring schema ensure the highest environmental quality for your process.

The following equipment is assigned to GMP service and exceeds the industry expectation for equipment qualification.  To learn more about KBI’s deployment of single-use technologies, please download our single-use schematic.

 Cell Culture Manufacturing

  • GMP_Akta_sm20L/50L Wave
  • 40L to 200L single-use (Xcellerex)
  • 400L to 2,000L single-use (Xcellerex)
  • Disposable POD Clarification
  • 2 AKTA Ready Chromatography (GE Healthcare)
  • Mobile TFF Skid using disposable membranes (UF/DF capability)
  • Nanofiltration
  • Disposable technology for buffer preps, product transfer, etc.
  • Cell Culture Analytical Tools:
  • Beckman Coulter Vi-Cell Counter
  • Radiometer ABL80 Flex BGA
  • Nova Biomedical Bio Profile Analyzer
  • Advanced Instr Osmometer model

Microbial ManufacturingGMP_Microbial_sm

  • 10L (Applikon)
  • 140L with max 100L WV (Applikon)
  • 2,000L fixed stainless steel fermentor with max 1,500L WV
  • Centrifugation- continuous flow
  • Centrifugation – intermittent discharge (Alfa Laval)
  • Homogenization (Niro)
  • Chromatography (GE Healthcare Bio-Process Skids)
  • Ultrafiltration / Diafiltration (UF/DF)
  • Nanofiltration
  • Bulk Fill

KBI possesses on-site warehouse capabilities for raw material and consumable storage awaiting use in the GMP manufacturing facility. This system comprises independent Quarantine, Release and Rejected areas. In addition, we maintained qualified cold storage space (2-8°C, -20°C and -80°C) for storage of materials and/or finished bulk drug substance.