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Mr. Shinya Takuma, President, Chugai Pharma Manufacturing, Japan

In a past interview with Mr. Shinya Takuma, President at Chugai Pharma Manufacturing Co. in Japan, shares valuable insights into the latest trends and challenges in the biopharma manufacturing space.


面试

| What is the approach to Personalised Healthcare (PHC) at Chugai Pharma?

Patients could be segmented by PHC, so more effective and more specific medicine for each segment would be desired. Accordingly the demand for each medicine could be smaller compared to widely used medicines. Under the situation, Chugai is trying to create an innovative medicine for a segment of patients using our proprietary antibody engineering technologies. We are also changing our facility strategy to decrease the bioreactor sizes; we have a range from 8 x 10kl, 6 x 6kl to 4 x 2k liters for clinical and commercial production so that smaller batches of products can be made

Source: Biopharmaceuticals in Perspective, 2016, PhRMA

Personalized Medicines use an individual’s genome for more accurate diagnosis and tailored prescription, which will decrease medical costs and unnecessary drug use. A total of 25% of drugs approved in 2015 were personalized drugs. 42% of new medicines in the pipeline and 73% of cancer medicines in the pipeline are personalized medicines.

| Are products manufactured in-house or through CMOs? What are the qualities that are considered?

Chugai works with many different CMOs in producing small molecules APIs, since we do not have enough capacity in house; the new Fujieda plant to begin construction at the end of 2019 is our own manufacturing facility for producing both small and medium size molecule APIs to improve process development and increase supply capacity. In the production of biologics, we have a new plant under qualification and expect to be validated by the year end with 6 x 6k liters capacity and 2 independent purification streams for simultaneous fed-batch production. In addition we value the added manufacturing capabilities brought by CMOs.Sustainability through Responsible Consumption and Production is also one of Chugai’s core strategy and we will take into consideration the sustainable supply of raw materials as well during manufacturing

| What are the key challenges facing Biopharma manufacturing at the moment?

The first is the need to decrease manufacturing cost through combinations of cutting edge technologies such as continuous manufacturing or ICT solutions. Aggressively speaking, the target could be halved or even more reduced. Secondly the pipelines of antibodies are quite robust at the moment but they cannot last forever and we will need to branch into new modalities such as midsize molecules or generative medicines


About Mr. Shinya Takuma

Mr. Shinya Takuma has been the president of Chugai Pharma Manufacturing Co., Ltd., a subsidiary of Chugai Pharmaceutical since 2016. He received the M.S. in Biotechnology from Osaka University in 1989 followed by entering Chugai Pharmaceutical, where he mostly worked in the field of Bio-API process development, mainly USP, including working for James M. Piret in the University of British Columbia for 2 years.

About Chugai Pharma Manufacturing Co., Ltd

Chugai Pharma Manufacturing Co. Ltd. is a subsidiary of Chugai Pharmaceutical Co. Ltd that is based in Japan. The company focuses on manufacturing drugs. The Company produces, processes, and sells drugs in pharmaceutical preparations for human and veterinary use.