Contract Manufacturing

U.S. and European pharmaceutical companies rely on contract manufacturing organizations (CMOs) to fill-and-finish highly technical and critically demanding parenteral pharmaceuticals. These CMOs are located in the United States and Europe, thus restricting a global organization’s full integration of operations and overall increased footprint into Asia, the geographic theater with the fastest and largest potential in both near and long term growth horizons. Other expansion options, such as green-fielding new aseptic operations in China, could prove both cost prohibitive per output, and highly time consuming to build, staff and train to internal a company’s standards.

PaizaBio offers an in-country solution that enables Western pharmaceutical companies to fast-track full operational integration of their manufacturing into the burgeoning China market, a solution that includes western cGMP quality standards and supportive, hands-on customer relations for successful Chinese commercialization.

PaizaBio has partnered with AUSIA BioTech, the leading Chinese CMO specializing in the sterile manufacture of parenterals for the pharmaceutical sector. Founded in 1993, AUSIA BioTech has established a reputation as China’s quality leader in the competitive and complex aseptic fill-and-finish market segment, with extensive capabilities in high volume filling of vials and lyophilization to Western standards.

AUSIA BioTech is unique in that it incorporates not only state-of-the-art equipment and techniques, but also emphasizes continuous improvement through sophisticated quality management systems. This includes a comprehensive digital and video-based management execution system, which captures both visual and process metrics allowing remote monitoring of aseptic fill-and-finish into final dosage forms in real time, offering client companies a new industry standard for quality validation and performance transparency.

To ensure only the highest level of cGMP quality manufacture, we have developed and staffed Asia’s only in-house, full scale aseptic training institute, The Sterile University, for the specific purpose of fostering optimal sterile technique and capability among our staff.


AUSIA BioTech at a Glance

  • Founded in 1993
  • Located in Hangzhou, China, approximately 120 miles/180 kilometers from Shanghai
  • 40,000-square-meter compound, including a 25,000-square-meter production facility and 10,000- square-meter warehouse
  • Laboratory facilities for testing, validation, analysis, and development
  • More than 600 employees
  • 9 high-speed automated filling lines
  • Full packaging facility with automated and manual options
  • Daily capacity of more than 1 million commercial vials

Capabilities

  • Aseptic vial filling
  • Lyophilization
  • Analytical services


Our true passion is delivering quality products with full transparency and complete confidence that advance patient care and quality of life. Quality always comes first. Start a conversation about your project. Contact Us.