One of the characteristic technologies that Spera Pharma took over from Takeda Pharmaceutical Company is chiral technology developed over many years in the Process Chemistry Division. All equipment and researchers related to the chiral technology were transferred to Spera Pharma, and the business will begin as a part of CMC one-stop service on July 1.
Chiral technology at Takeda Pharmaceutical Company started about 20 years ago under the supervising by the scientist who had returned from research at the ERATO Noyori molecular catalysis project. Since then, we have worked on a wide range of initiatives such as the research and development of asymmetric hydrogenation and other asymmetric organometallic catalysis, chiral column technologies for analysis and preparative HPLC, enzyme technologies with high enantioselectivity, and diastereomeric salt technologies that are indispensable process for practical manufacturing, all in order to develop manufacturing methods of new chiral drugs. Spera Pharma will offer solutions that meet customer needs using one or a combination of these technologies. In particular, screening services such as the selection of chiral stationary phases, selection of asymmetric catalysts, selection of enzymes and selection of diastereomeric salts that utilize high throughput screening technology are offered at speeds to meet customer satisfaction. We have also skilled capability of scale-up manufacturing using these chiral technologies. For GMP manufacturing we have autoclaves (300, 500 L) and filtration dryers specialized for air-sensitive catalyst preparation. We have conducted asymmetric hydrogenation at a commercial scale of 10,000 L. Further, as peripheral technology, Spera Pharma can conduct metal scavenger screening for residual metals and set up the deoxygenation conditions for organometallic catalysis.
For asymmetric catalysis we have conducted not only catalyst screening using commercial catalyst libraries, but has also developed high-performance catalysts with improved enantioselectivity and reactivity through the fine tuning of catalyst depending on the various substrates. We have also been contributing to the progress of the chiral technology by publication of our achievements through a wide range of media such as patents, academic papers and presentations at conferences. Mitsuhisa Yamano will present our case studies of the catalytic asymmetric hydrogenation for practical API manufacturing processes as the keynote lecture at Chirality 2017 (http://chiralitytokyo2017.jp/plenary_lectures.html) held at Waseda University in July 2017.