China-based TOT BIOPHARM Starts Stage II Construction for Commercial Production of Monoclonal Antibody Drugs

Monday, October 17, 2016 Drug News J E 4

SUZHOU, China, Oct. 17, 2016 /PRNewswire/ -- Chinese bio-pharmaceutical developer, manufacturer and marketer of anti-cancer drugs TOT BIOPHARM Company Limited today formally broke ground on  its stage II construction of the second phase monoclonal antibody drug production facility at Suzhou Industrial Park.

Industry leaders, officials and invited guests, including Director of Taiwan Affairs Office of Suzhou City Yang Jun and Deputy Director of Suzhou Industrial Park Administrative Committee Sun Yan Yan, attended the ceremony where they witnessed a new milestone in China's biopharmaceutical industry.

Ms. Sun and Chairman of China Medical University Hospital and Asia University Cai Changhai delivered a passionate speech at the event, expressing the hope that TOT BIOPHARM can leverage the opportunity to further improve corporate performance, take the lead in the transformation of the industry, optimize the industrial structure, increase the firm's participation in international exchanges, continue to make progress through collaborations, and promote sustainable and healthy development.

Established in Suzhou Industrial Park in 2010, TOT BIOPHARM adheres to the management philosophy of "a balance between humanity and technology" and aims to discover and develop innovative anti-cancer drugs and therapies that address the world's unmet medical needs.

The company develops new drugs with high technical barriers and economic value as well as anti-cancer products specifically designed for the healthcare environment in China, offering patients the most suitable and affordable product portfolio for the benefit of the greater good.

TOT BIOPHARM completed construction of its Stage I plant and put it into operation in 2012. The company continued to increase investment, resulting in the establishment of a new monoclonal antibody drug factory in 2016, a facility that will focus on manufacturing monoclonal antibody drugs and antibody-drug conjugates (ADCs).

The new factory is scheduled to undergo a series of tests and be put into trial production in 2018, followed by formally rolling out commercial production in 2019. Once construction is completed, the facility will have five production lines with a cell culture capacity of 2,000L and a production capacity of 10,000L of monoclonal antibody drugs.

The company's monoclonal antibody drug factory will use disposable bioreactor systems to increase process safety and reduce manufacturing costs. In addition, the facility plans to establish three production lines for preparations, which can output tens of thousands of monoclonal antibody drugs and fulfill the diversified filling specifications for different products in one pass. The factory will be able to produce millions of pre-filled preparations and up to 1.5 million lyophilized preparations annually.

An OEL-5-level ADC workshop, with an annual production capacity of 120 kilograms, will make extensive use of isolators during the manufacturing process in a move to be ready and able to address market supply needs as demand for its ADC products increases.

TOT BIOPHARM's monoclonal antibody drug factory is designed to be flexible in terms of production capacity ramp-up and adjustments in space allocation. After formally being put into operation, the factory, combined with an existing 500L biopharmaceutical pilot-scale platform, is capable of meeting top-down demand from the biopharmaceutical sector for upstream research and development, pilot-scale production, clinical test drugs and commercial production, while simultaneously or alternatively producing over ten types of antibody drugs with an annual production capacity reaching hundreds of kilograms.

China has been in the process of deepening reform, facilitating innovation and entrepreneurship and providing companies with new opportunities. Biopharmaceuticals, especially antibody drugs, are highly valuable in terms of treatment of tumors and other critical illnesses.

The factory, with its strong industrial competence and efficient production capabilities, can be expected to provide high-quality yet low-cost drugs to patients, acting to cut the country's medical costs while enhancing the global competitiveness of China's domestically-produced drugs.

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