Source: TaiMed Biologics
TaiMed Biologics (TaiMed) announced today that its board approved a plan to expand its business model from biologic drug innovator to Contract Development and Manufacturing Organization (CDMO).
In response to the international market demand for biologic drugs and commissioning of its Zhubei cGMP production plant last year, TaiMed has the capability and capacity to produce monoclonal antibodies meeting clients’ needs.
According to statistics from Global Information Inc., the market size of biologic medicines is growing at a compound annual growth rate of 8.3%, and is expected to reach a scale of US$394.2 billion in 2026. In the past two years, the COVID-19 epidemic accelerated the trend, which boosted the global demand for CDMO services. Considering this trend, TaiMed has decided to enter the CDMO business.
Since its establishment in 2007, TaiMed has devoted itself as the developer and manufacturer of innovative biologic drugs. The company successfully developed a first-in-class anti-HIV antibody drug TMB-355 (trade name Trogarzo®) which the US FDA and EU EMA approved in 2018 and 2019, respectively. Recently, TaiMed also completed a Phase 3 label extension clinical program in the United States and submitted an sBLA marketing application to the FDA at the end of last year. In addition, TaiMed has additional novel antibody drugs in clinical trials in the United States.
In 2017, TaiMed invested US$35 million to construct a cGMP monoclonal antibody manufacturing facility in Zhubei Biomedical Park in Taiwan. The construction of the Zhubei Plant was completed last year, and the design complies with the cGMP requirements of the US FDA, the EU EMA, and the latest ICH guidances. The 60,000 square foot plant is equipped with state-of-the-art cell culture bioreactors, purification skids, and analytical instruments. The manufacturing capacity is one of the largest in Taiwan.
TaiMed has more than 10 years of experience in monoclonal antibody development and production and has successfully produced supplies from this facility for clinical studies conducted in the United States. The facility utilizes single-use technology to maximize manufacturing flexibility cost-effectively. It is also equipped with qualified single-use bioreactors at 200L to 2000L sizes, adequately sized AKTA downstream purification systems, and UF/DF skids to handle production needs. The available CDMO services include process development and scale-up, analytical method development and validation, formulation development, GLP/GMP production, and regulatory services. The preparation of regulatory CMC documents is one of the strengths of TaiMed. Over the years, TaiMed prepared multiple global IND and BLA regulatory filings. TaiMed strives to provide customers with high-quality contract services at a competitive cost.