Advancing the chemistry of pharmaceutical manufacturing in Japan

A strategy providing sustainable value to the global pharmaceutical industry increasingly involves outsourcing with contract development and manufacturing organisations (CDMO) that are positioned operationally, technically and geographically to effectively serve global markets. Currently, the worldwide pharmaceutical sector is expanding at a robust compound annual growth rate (CAGR) of 6.3% and according to EvaluatePharma, global pharmaceutical R&D spending is also increasing annually at approximately 2.8%.¹ This worldwide spending is driving global growth and is expected to increase added revenues derived from new products currently in the R&D pipeline by 50% in 2022.¹

Tapping the legacy of Takeda’s CMC R&D technology

In the context of global pharmaceutical trends, Japan has seen the emergence of its own contract research, development and manufacturing services industry, including Bushu Pharmaceuticals Group, which operates Bushu Pharmaceuticals Ltd. Bushu has been steadily growing to compete for global Pharma 3.0 business in Japan and the Asia-Pacific region.

Bushu has deep roots when it comes to fielding integrated operations and a highly developed quality culture — stemming from its Japanese heritage and legacy affiliations with Sandoz, Novartis and Japan’s Shionogi & Co. Since 2005, the company has worked to establish its “one-stop” business model, becoming one of the few single-source, end-to-end chemistry, manufacture and control (CMC) contract services providers in Japan.

Bushu has provided supply chain services to a broad range of multinational pharmaceutical companies during the past decade and is the country’s largest comprehensive contract development and manufacturing organisation (CDMO) with operations aligned to suit its clients’ international go-to-market strategies.

Bushu’s one-stop capabilities gained new depths in July 2017 when Takeda spun-out part of its pharmaceutical sciences chemistry, manufacturing and controls (CMC) business — a move that paved the way for Bushu’s acquisition of a major element of Takeda’s R&D business — known now as Spera Pharma, Inc. The Spera Pharma subsidiary integrates Takeda’s Pharmaceutical Sciences business and facilities, including approximately 200 employees from three main divisions: Chemical Research and Development, Pharmaceutical Technology Research and Development, and Analytical Research and Development.

With Spera, Bushu now offers the full range of CDMO services, from preclinical CMC R&D through regulatory filing and technical transfer stages, and on to clinical trial materials (CTM) and commercial manufacturing. Under the Bushu umbrella, Spera Pharma is responsible for the entire CMC process, from R&D through to application.