PiazaBio Set to Launch Ops at CPhI

PaizaBio is a New Mexico-based contract manufacturing organization (CMO) and marketing agent designed to provide Western pharmaceutical companies with high-level support and rapid entry into the rapidly growing Chinese aseptic drug market. Operating under the vision of “In China, For China, To Western Standards,” PaizaBio is committed to quality, integrity and an innovative approach to products and services, including Asia’s first dedicated “Sterile University” training program.

According to the company, 90% of pharmaceutical company executives surveyed include China in their growth plans. With a population of 1.4 billion, China is larger than North America, South America and Europe combined. It’s also the third largest drug market in the world, valued at $150 billion. According to PaizaBio, many Western drug companies are on the sidelines.

Led by pharmaceutical industry veteran Stuart Rose, PaizaBio is offering something it says is novel to Western pharmaceutical companies: immediate, low risk, low cost, high value entry into China’s growing sterile injectables market. Mr. Rose’s company gets its name from a gold medallion called a “paiza” presented to Marco Polo by the Emperor Kublai Khan in the 13th century, assuring Polo of safe travels while trading in China. PaizaBio’s official launch is October 12 during CPhI Worldwide in Madrid, Spain.

“Then, as now, China offered tremendous business opportunities to the West. Marco Polo was fortunate that Kublai Khan welcomed him, reducing his risk of doing business in China,” said Mr. Rose. “With PaizaBio, we have created something similar—a safe ‘portal’ to the Chinese sterile injectables drug market for Western pharmaceutical companies.”

Mr. Rose is drawing on four decades of experience in global pharmaceutical manufacturing and logistics and a decade-long relationship with Shaofeng Huang, the founder of Ausia BioTech, a contract manufacturing organization (CMO) with two decades of experience in aseptic fill-and-finish. Located in Hangzhou, China, Ausia BioTech is among China’s largest CMOs, with annual capacity in excess of 300 million units.

Operating under the mantra “For China, In China, To Western Standards,” PaizaBio has implemented a number of processes and services to ensure quality, competitiveness, and transparency in China, issues of paramount importance to Western pharmaceutical companies. These include the Trans-Pacific Aseptic Training Institute (TPA-IT), a multi-million dollar on-site, full-scale “sterile university” for training a qualified aseptic workforce; BAO-Gong, the pharmaceutical industry’s most comprehensive real-time digital and video production monitoring system; and sophisticated lyophilization services, that dramatically reduces drying cycles, maximizing output and lowering cost.

PaizaBio’s current manufacturing presence in China includes a 40,000-square-meter compound, encompassing a 25,000-square-meter production facility and 10,000-square-meter warehouse. Production equipment includes nine high-speed, automated filling lines for vials, cartridges and syringes; ten high-speed capping lines; full packaging facility with automated and manual options; four formulation tanks with total capacity of 3,000 liters; and laboratory facilities for testing, validation, analysis, and development. Additionally, PaizaBio offers clients expertise in Chinese regulatory compliance.

Mr. Rose envisions some pharmaceutical companies will want an ongoing relationship, while others will use PaizaBio to test the Chinese market before constructing their own facility. “China is not an easy market to enter successfully. Our clients will enjoy rapid entry in the Chinese market with no significant capital outlay, and with a partner that provides manufacturing innovation and quality products that meet China’s regulations, in the formats and packaging the market prefers.”