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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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