Microbial CDMO Services

Creative Biogene is a biotech CDMO for bacterial and yeast-based production of Drug Substances. Our microbial production services include GMP production of recombinant proteins, plasmid DNA, single-domain antibodies, recombinant vaccines, nucleic acid drugs, etc. Our microbial GMP-manufacturing unit is equipped with state-of-the-art fermenters, harvesting equipment, and a choice of downstream purification capabilities. Manufacturing and purification options cover both secreted and intracellular products.

Service Capabilities

Microbial CDMO Services

Cell Banks Generation (RCB, MCB / WCB)

Items Assay RCB MCB WCB
Strain Identification Viable Bacteria
Colony Morphology
Microscopic Examination
Biochemical Characteristics
16s rDNA
Bacteriophage
Plasmid related Characteristics Antibiotic Sensitivity
Plasmid Retention Rate
Plasmid Copy Number
Yield
Plasmid Identification Homogeneity
Restrict Endonuclease Digestion
Purity
Sequence

Upstream Processes

  • Stirred Tank bioreactors
  • Bacteria and yeasts fermentation
  • Target protein expression
  • Tangential flow filtration or continuous centrifugation
  • Cell homogenization
  • Enzymatic treatment
  • Harvest clarification (TFF, continuous centrifugation or deep filtration)

Downstream Processes

  • Protein denaturation/Refolding
  • Chromatographic purification (AIEX, CIEX, Multimodal, SEC, Column and membrane chromatography)
  • Tangential Flow Filtration

Quality Assurance and Quality Control

  • Microbiological product-specific assays
  • Analytical Services and Safety Assays (sterility, Bioburden, and Endotoxin, etc)
  • Compendial analyses and full GMP documentation

Advances in synthetic biology and a shift towards sustainable manufacturing methods are helping to drive demand for the selection of CDMOs with best-in-class microbial fermentation capabilities. Creative Biogene has served as a reliable fermentation partner to pharmaceutical companies. We have leveraged our expertise across fermentation and biocatalysis technologies including strain development, process optimization and large-scale manufacturing. We are ready to support your upcoming projects regardless of scale or complexity.

If you are interested in our services, please contact us for more details.

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