GMP Scale Up Services

To realize large-scale production of live biotherapeutics products for industrial applications, Creative Biolabs provides GMP process scale-up service from laboratory scale batches to manufacture scale batches step by step. Our scale-up packages include developing effective technologies to meet different scales process, scale-up process development, and industrial production including fermentation, freeze-drying, formulation, and packaging.

GMP Scale-Up Facility

Creative Biolabs has developed and established a series of facilities to support GMP scale-up manufacturing and production of live biotherapeutics products for experimental research and clinical trials. Our scale-up units are integrated into a full GMP suite and contain the following materials:

GMP Scale Up Services
  • Fermenters with working volume from 20 to 3500 liters (20 liters fermentor for pre-clinical models; 300 liters fermentor for phase II or small phase III; 3500 liters for phase III with large population)
  • Freeze drying equipment with a large freeze-drying capacity
  • Single-use bioreactors with the capability to 40 liters scale
  • Temperature control, including fermentation stabilization by cooling
  • Biomass concentration, with the possibility to enrich the culture medium with any kind of gas (ex: oxygen, nitrogen, etc.)
  • Plate centrifugation
  • Cryoprotectant mixing tank
  • Homogenizer Mixer
  • Microfluidizer
  • Milling Machine
  • Filling Machine
  • Packaging of concentrated powders in pouch, vacuum sealed and at -20 ℃

In addition to the scale-up unit facility, we also establish a set of equipment for quality control in the scale-up process, including:

  • HPLC
  • Spectrophotometers
  • PCR
  • Plate readers fluorescent and UV
  • Fume hoods

Our Capacity

GMP Scale Up Services

Our facility is designed to support GMP scale-up service for the production of live biotherapeutics products. With our state-of-art scalable processing equipment, Creative Biolabs help you achieve efficient, stable, consistent process scale for live biotherapeutics products from process development, laboratory scale, pilot scale to GMP production, thereby accelerating the transition to industrial production. We are skilled in process design, closed system design, bioburden control, defining valid specifications, and GMP-compliant production and control records.

  • Single-use system and reactors
  • Laboratory scale
  • Pilot-scale
  • Industrial-scale

Advantages

  • Sophisticated cGMP facilities for the production of live biotherapeutics products
  • A professional expert team providing optimal customization solutions
  • Strict quality control
  • High-quality products delivery
  • Shorter production cycle

If you are interested in our GMP scale-up services for the production of live biotherapeutics products, please contact us to discuss your project.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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