Speciality Chemicals Magazine MAR / APR 2022 | Page 33

PHARMACEUTICALS

‣ Many companies have joined the chiral intermediate market using chiral technologies . Takasago industrialised the asymmetric transition metal catalyst explored by Noyori , while Kaneka and API Corporation developed the enzymatic transformation examined by Shimizu as a commercial manufacturing method . Japan is one of the leading countries in flow chemistry . Yoshida and Nagaki established the concept of ‘ flash chemistry ’, which facilitates chemical reactions not amenable to the usual batch process . ⁷ Kobayashi established the concept of flow ‘ fine ’ synthesis and achieved the flow total synthesis of several APIs using a heterogeneous column catalyst . ⁸ Several industrial consortia are working on the installation of continuous production for commercial processes . Fujifilm Wako Chemicals has a large-scale continuous GMP production capability , which reduces costs in the BuLi process . Continuous stirred-tank reactor ( CSTR ) technology also plays an important role in chemical production innovation , and various chemical companies in Japan have announced the application of CSTR technology for fine chemical production . Juzen Chemical recently started to develop the CSTR process for the Grignard reaction , which has a low yield in batch processing but was still successfully scaled up at a GMP production plant using this technology . The demand for highly potent APIs ( HPAPIs ) is increasing due to the advances in anticancer drug discovery . The total number of new drugs in the oncology pipeline reached almost 3,500 in 2020 ,

HPAPI facility at Juzen Chemical

increasing by 75 % since 2015 , marking a large investment and research focus to address many clinical needs . ⁹ The number of dedicated containment facilities for HPAPIs is also increasing for many API manufacturers in Japan . Juzen Chemical , for instance , constructed a multi-purpose HPAPI plant in 2015 ( pictured ) and several anticancer drugs have been commercially produced . Along with the expansion of modalities in pharmaceutical research , business opportunities for the manufacturers of medium-sized drugs , such as peptide and nucleic acid drugs , are increasing . In particular , the development of RNA vaccines against COVID-19 has become a driving force for expanding the medium-sized drugs sector and has accelerated the development of therapeutic tools that target the RNA . Many CDMOs in Japan , such as Nitto Denko , Ajinomoto and Nippon Shokubai , are working on peptide or nucleic acid synthesis at a commercial scale . Juzen Chemical is also working on efficient synthesis of new amidites and oligonucleotides . Currently , many pharmaceutical start-ups have been established in Japan . As they focus on drug discovery , the demand for chemistry , manufacturing , and control ( CMC ) solution services , such as route selection , process refinement , analytical development , and formulation , is increasing . Large pharmaceutical companies are also following the trend to save the resources devoted to CMC functions , and the expectation from CDMOs for CMC support is increasing . Juzen Chemical began its CMC solutions service in 2017 . Recently , the ‘ ecosystem ’ that accelerates open innovation among pharmaceutical companies , start-ups , and academia has been recognised as a key factor in drug discovery . Shonan iPark , a research hub established around Takeda ’ s Shonan Laboratory , now houses 120 companies that specialise in various domains of pharmaceutical production and next-generation biotechnology . Juzen Chemical became the first CDMO to establish a laboratory there in 2020 . •

Kazuya Okano

JUZEN CHEMICAL CORPORATION k + 81-3-3527-1560 J k . okano @ juzen-chem . co . jp j www . juzen-chem . co . jp /

MAR / APR 2022 SPECCHEMONLINE . COM

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