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.
