cGMP Manufacturing

Ajinomoto Bio-Pharma Services is a recognized leader in recombinant protein, plasmid DNA and critical raw material manufacturing

With a range of production scales, outstanding regulatory record, and significant microbial-based manufacturing expertise, we provide a tailored manufacturing solution for each microbial drug substance.

Product Types

Reliable, robust, tailored development and cGMP manufacturing services for wide variety of microbial programs.

  • Recombinant proteins
  • Fusion proteins
  • Antibodies and antibody fragments
  • Plasmids (therapeutic or as a critical raw material for gene therapies)
  • Peptides
  • Vaccines

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.

Upstream: Fermentation & Product Recovery

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

  • 100 L, 120 L and 1,000 L fermenters
  • Microfluidizer
  • Homogenizers
  • Single use mixers up to 2,000 L scale
  • Dead end and continuous centrifuges

Downstream: 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 Filtration and Tangential Flow Filtration (TFF) systems
  • AKTA Ready and Pilot 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.