BioZyme Inc. Fermentation Capabilities

BioZyme Inc. Fermentation Capabilities

BioZyme is SQF, SFSF, NASC, GMP and FSMA compliant and has a HAACP (Hazard Analysis Critical Control Point) program. We are also FAMI-QS certified, so our facility operates at the highest level of cleanliness, sanitation, traceability, and accountability.

We follow extensive quality control checkpoints to ensure safe, accurate product from start to finish.

BioZyme is SQF, SFSF, NASC, GMP and FSMA compliant and has a HAACP (Hazard Analysis Critical Control Point) program. We are also FAMI-QS certified, so our facility operates at the highest level of cleanliness, sanitation, traceability, and accountability.

We follow extensive quality control checkpoints to ensure safe, accurate product from start to finish.

Overall Production Parameters

  • Media preparation executed in a mix tank with transfer to a holding tank via heat or filter
    • Powder Induction Mixer for media preparation with shear pump to ensure maximum ingredient dispersion and dissolution.
  • Typical seed train includes:
    • Glycerol stock or isolation plate
    • Shake flask
    • Seed fermenter
    • Production fermenter
  • All sterile seeding procedures of fermenters occurs via:
    • Glycerol stock/isolation plate to seed shake flask in biosafety cabinet
    • Seed shake flask to seed fermenter through steam docking
    • Seed fermenter to production fermenter through steam sterilized transfer line
  • Available nitrogen sources:
    • Organic and inorganic
    • Ammonia at 19% concentration

Utilities

Our facility is set-up with redundant utilities and generator back-up power.

  • Chiller
    • 60-ton air cooled water chiller with 40° F discharge
    • 1000 tons of glycol chilled capacity capable of -10° C discharge
  • Air
    • Ingersoll Rand and Atlas Copco compressors capable of producing >1vvm of fermentation capacity with oil free air
  • Steam
    • 150 HP Clayton steam generator
    • 400 HP Clayton steam generator
    • Clean steam generator
  • Water treatment
    • Softened and de-chlorinated (carbon filtered) processed water
  • Electricity
    • 600 amps on backup generator
    • Substation within 0.25 miles for expanded capacity

Micro Lab

  1. Biosafety cabinet
  2. Bright field/phase contrast microscope with camera (100X oil)
  3. Multiple incubators/shakers
  4. Multiple minus 80° C freezers
  5. Microcentrifuge

Analytical Lab

  1. Microwave Digestor and ICP-OES
  2. Ash Oven
  3. Leco Protein Determination
  4. UV/VIS
  5. HPLC – RID/DAD
  6. Ion Chromatography
  7. GC-FID
  8. Laser Diffraction Particle Size Analysis

Fermentation Capabilities

  1. 5L and 14L New Brunswick
  2. 20 L Sartorius fermenter
  3. 60 L Applikon fermenter
  4. 150L Sartorius fermenter
  5. 300L Applikon fermenter
  6. 260 L Sartorius fermenter
  7. 2000 L ABEC fermenter Two 10,000 L fermenter
  8. Two 15,000 L fermenters
  9. Four 25,000 L fermenters
  10. Heat sterilization
  11. Filter sterilization

Downstream Processing

  1. Surge tanks
    1. 2 x 11,000L
    2. 1 x 30,000L
  2. Blending tanks
  3. Ekonek pulse combustion dryer—700kg/hr Evaporation Capacity
  4. Micro/ultra/nano/RO filtration system
  5. Shear mill
  6. Premier Tech (PT) powder bag (5 to 10 kg) filling (fed from tote bags) and palletizing

Waste Processing

  • Frac Tank
  • 7,000-gallon waste tank with heat treatment capabilities, 30,000-gallon waste tank, limited chemical pretreatment options.

Other Support

  • 24-hour staffing 7 days a week
  • Loading docks
  • Warehousing (4° C to 22° C)
  • Refrigeration room (forklift accessible)

30 minutes north of Kansas City International Airport

Ready to take the next step?

With a foundation built on decades of expertise and a full suite of contract manufacturing services, BioZyme is uniquely positioned to meet your needs. Let us be the partner you can rely on for results that are safe, accurate, and on time.