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cGMP Manufacturing

Protein/Plasmid DNA Production With a range of production scales, outstanding regulatory record, and significant microbial-based manufacturing expertise, we provide a tailored and cost-effective manufacturing solution for each microbial drug substance.

As your program advances in the clinic, we provide the capacity and quality to scale your process to larger product volume requirements without changing facilities. Leveraging this capacity eliminates the need for redundant technology transfer and qualification of additional service providers.

Product Types

  • Recombinant proteins
  • Fusion proteins
  • Antibodies and antibody fragments
  • Plasmids
  • Peptides
  • Vaccines

Fermentation & Product Recovery Ajinomoto Bio-Pharma Services offers complete cGMP production of bacterial and yeast expression-based drug substances.

  • 30 L, 100 L and 1,000 L fermenters
  • Microfluidizer
  • Homogenizers
  • Single use mixers up to 2,000 L scale
  • Dead end and continuous centrifuges

We utilize well-established protocol-based technology transfers to bring in customer developed processes; alternatively, we can employ the efficient processes developed and/or optimized by our own process development scientists.

Purification & Formulation Our purification suites are equipped with a wide range of qualified equipment that accommodates a variety of methods and scales of primary recovery, inclusion body preparation, solubilization with refolding, chromatography and filtration required to support production up to 1,000L scale.

  • Depth and Tangential Flow Filtration (TFF) systems
  • Chromatography systems

The final substance can be packaged as purified bulk drug substance or seamlessly transferred to our Fill Finish facilities for final drug product manufacturing.