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Pharmaceutical Engineering
Pharmaceutical engineering refers to the design and optimization of manufacturing processes
for the efficient and safe production of pharmaceutical products. MBRI has been focused for many years on
recombinant protein-related research including purification, formulation and drug delivery.
Purification process
We have now developed several purification processes for therapeutic recombinant proteins such as human
interferon alpha, G-CSF and PTH. In vitro protein refolding and pilot scale chromatography are central
techniques in this field and require accumulated skills in protein biochemistry, analytical chemistry, functional
assays and process engineering. We have previously established various strategies for large-scale protein
purification, which are currently being applied to our novel anti-angiogenic protein, rhLK8.
Formulation Research
Before conducting formulation work, we study the characteristics and chemical stability of purified recombinant
proteins using physicochemical methods. Information acquired in this way is then analyzed to design appropriate
formulations. Some therapeutic proteins, such as anti-angiogenic polypeptides, are required in large dosages and
to resolve this issue we designed a high concentration formulation method in either a liquid or a crystal type.
The crystal type formulation is superior in stability during storage and additionally has a reduced viscosity.
Long-acting Recombinant Therapeutics
Recombinant proteins often have the advantage of both specificity and low toxicity, but also have the serious
limitation of a short half-life in the body. To overcome this problem, we have applied PLGA microsphere and
pegylation technologies to the generation of recombinant protein drugs. PLGA microspheres enable the sustained
release of therapeutic proteins into the body and we have now established techniques for controlling the size
and encapsulating efficiency of our microspheres, and applied this technology to G-CSF. Pegylation technology is
also used to increase the half-life of therapeutic proteins. We have developed site-specific pegylation
technology, superior to conventional methods, and successfully applied this to the production of therapeutic
proteins, such as cytokines and anti-angiogenic protein.
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