Bushu Pharmaceuticals’ Misato facility is being expanded with an investment of $100m. Credit: Bushu Pharmaceuticals Ltd.
A new cold chain warehouse is being constructed at the Misato facility for the storage of temperature-controlled sterile drugs and biologics. Credit: Bushu Pharmaceuticals Ltd.
The cold chain facility will be commissioned by the end of September 2020. Credit: Bushu Pharmaceuticals Ltd.

Bushu Pharmaceuticals unveiled a new expansion programme for its pharmaceutical manufacturing facility in Misato, Japan, in August 2020.

With the estimated investment of $100m, the new capital programme will expand the company’s footprint, capability, and range of services to the clients. The programme will be implemented over the next five years.

The additional capacity and inspection lines in the facility will facilitate the entry of greater volume of bulk goods into the country, making the clients’ logistics and supply chain processes competent.

Bushu Pharmaceuticals’ manufacturing facility location

Established by Eisai in 1981, the Bushu Pharma’s Misato facility is located in Misato-machi, Kodama-gun, in Saitama prefecture.

The site covers an area of approximately 173,000m², divided into a pharmaceuticals manufacturing area and welfare facilities area, including a gymnasium and park.

 The facility has a floor area of approximately 57,000m², encompassing a solid dosage manufacturing building, an injectables building, a warehouse, and a quality control (QC) space.

Details of Bushu Pharmaceuticals’ manufacturing facility expansion

The expansion programme of the manufacturing facility includes the addition of a new cold chain warehouse facility spanning 3,900m². It will be utilised to store temperature-controlled sterile drugs and biologics for export to the market in Japan.

The ground-breaking ceremony of the new cold chain centre was held in September 2019.

The centre was recognised as an advanced and productive business plan, under the Regional Future Investment Promotion Law, and obtained specific privileges and funding from the Ministry of Economy, Trade, and Industry and Saitama prefecture in May 2020. The facility will be commissioned and validated by the end of September 2020.

The new earthquake-resistant facility is crucial to the company’s ‘Asia hub’ initiative. The initiative helps foreign pharmaceutical firms in Japan to import bulk products for quality inspection, labelling, packaging, and marketing across Japan and other Asian countries.

A total of 26 inspection stations will also be added to the facility to improve the inspection capability, of which 23 will be equipped with cameras. The inspection stations will include 12 stations for pre-filled syringes, seven for liquid vials and seven for lyophilised vials.

Bushu will also add eight new packaging lines, including one pre-filled packaging line and a water-for-injection line to strengthen its sterile manufacturing filling suite at the facility.

The company will also update the production automation infrastructure and the laboratory information management system (LIMS) as part of its long-term information technology (IT) master plan.

Bushu’s collaboration with several pharmaceutical companies globally has underpinned the establishment of the company’s international technical transfer team.

The extended team will promote the transfer of analytical methods and allow the validation of foreign drugs into the two manufacturing facilities of the company.

Existing Bushu manufacturing facility details

The existing facility features a large area for manufacturing and packaging of solid dosage, which is double the size of the company’s Kawagoe facility.

Manufacturing Building 1 and the N1 Workroom in the solid dosage manufacturing area are utilised for the production and packaging of the sugar-coated, film-coated and plain tablets. The tabletting and coating machines in the building are run primarily during the night for enhanced output.

The packaging area for solid dosage contains a filling space, primarily for packaging, and a packaging space for secondary packaging.

Manufacturing Building 2 includes an area for manufacturing and packaging injectables, with extended capability for ampoules, vial, pre-filled syringe, and freeze-dried pharmaceuticals.

It has an integrated system for the processing, filling, and sterilisation of liquid pharmaceuticals (except aseptic packaging).

It contains three sterile ampoule lines, one vial line, one pre-filled syringe line, and one freeze-dried pharmaceutical line.

A structure called J Centre supports manufacturing at the facility. All the raw materials, packing materials, and goods move into the warehouse for dispatch. J Centre has large-scale automated racks to hold 3,860 pallets.

Marketing commentary on Bushu Pharmaceuticals

Founded in August 1988, Bushu Pharmaceuticals is a pharmaceuticals contract development and manufacturing organisation (CDMO) based in Japan.

Bushu undertakes contract manufacturing and packaging of clinical trials and commercial products in compliance with the new good manufacturing practice (GMP) guidelines.

The Misato manufacturing facility of Bushu Pharma has received GMP certification in Japan, the US, Europe, as well as in other regions, including South America and Africa. Its production business is capable of processing a range of over-the-counter (OTC) medicines and prescription medicines (anticancer medications, orphan medicines, regenerative medicines).