Friday, November 4, 2022

Pfizer Pharma has operated in the fast lane for decades

11-24-09 Pfizer says to expand
R&D in central, western China By Reuters Staff HONG KONG, Nov 25 (Reuters) - Pfizer Inc PFE.N plans to expand its research and development operations in central and western China as it strengthens its biomedical infrastructure throughout the country, the company said on Wednesday. Pfizer (China) Research and Development Co Ltd will team up with its Chinese partnerm Wuhan National Bioindustry Base Construction and Management Office, to establish a new Pfizer R&D centre in Wuhan, expand its existing R&D facility in Shanghai and serve as a platform for global drug development and strategic biomedical alliances. “With plans to be a state-of-the-art facility, the Wuhan center will be an integral part of Pfizer’s global R&D operations while being closely aligned with the Chinese government’s strategy on biopharmaceutical industry development in the region,” Allan Gabor, the company’s Regional President for North Asia, said in the statement. Pfizer’s R&D operations in Wuhan will support global clinical drug development programs, including Phase I-IV clinical trials, and will utilize the resources of local staff and industry to develop research collaboration on drug innovation and development. The number of employees in the facility will grow to 200 within 3 years, it said. Shanghai will remain the operations hub of Pfizer’s R&D in China. It gave no further details on the investment. Many major drug makers are speeding up their investments for research and development in China in a bid to take advantage of the low cost of employees and high growth potential of the mainland market. Earlier in November, Swiss drugmaker Novartis AG NOVN.VX said it was investing $1 billion to build the largest pharmaceutical research plant in China, emphasising the importance of developing markets for future growth. [ID:nL3525806] (US$1=HK$7.75) (Reporting by Donny Kwok; Editing by Ken Wills) ((donny.kwok@thomsonreuters.com; +852 2843 6470; Reuters https://www.reuters.com/article/pfizer-research-idCNHKG35399420091125 (Pfizer later transferred their quality-control unit from India to China. -r) ………….. June 30, 2016  Americans and Europeans are most likely to die from heart disease. But in China the leading cause of death is cancer. The disease killed nearly 3 million Chinese in 2015 alone and the country's doctors have few drugs available to fight the epidemic. As grim as the numbers look, they could soon start changing. That's because healthcare reforms recently enacted by the Chinese government support local production of a next-generation class of drugs called biopharmaceuticals and new, flexible drug production methods. Global pharma companies like Pfizer Inc. are paying attention. The New York City-based drug maker recently announced it would build a new $350 million China Biotechnology Center focused on manufacturing biopharmaceuticals. Unlike ibuprofen with its simple chemical formula, biopharmaceuticals, also called biologics, are a class of medicines made from strings of complex living proteins that are used as therapies for ailments as different as autoimmune disorders, diabetes and, of course, cancer. Biologics account only for 4 percent of the medicines prescribed in China, compared with 22 percent in the United States. KUBio can help increase their reach. Image credit: GE Healthcare Life Sciences Biologics, which are manufactured in bioreactors from living cells, have mainly been available in wealthy countries. The new center is aiming to change that. It will use KUBio, an innovative prefabricated factory on wheels for making biologics developed by GE Healthcare Life Sciences. KUBio’s 62 portable modules come equipped with single-use bioprocessing technologies as well as the walls needed to enclose them. GE can deliver the plant to locations where it might otherwise take years to build a traditional biopharma facility. The KUBio at Pfizer’s center in Hangzhou, China, will be ready in 2018. The facility will be the drug maker's third global biotechnology center and its first in Asia to make biologics and biosimilars, licensed and highly similar drugs to already-approved biologic medicines. “The local production of high-quality, affordable biosimilar medicines will have the potential to significantly improve the lives of patients not only in China but across the world,” says Tony Maddaluna, Pfizer’s president of global supply. Pfizer says it chose a KUBio because it can help slash factory construction time in half, to 18 months from three years. The design also costs 25 percent to 50 percent less than building a traditional factory. The facility’s operation is also less harmful to the environment, reducing CO2 emissions by 75 percent and water and energy use by 80 percent. Frost & Sullivan's forecast has China’s biologics market reaching $9.32 billion in 2018 from $4.06 billion in 2013. Pfizer’s KUBio will make biologics in multiple 2,000-liter single-use bioreactors. Making drugs in single-use disposable plastic bags in reusable containers eliminates costly cleaning and sterilization and makes the plant more efficient. The factory can also quickly switch between drugs, allowing Pfizer to make new biopharma drugs should the need arise The KUBio modules are manufactured in Germany and the equipment inside comes from the United States and Sweden. “The KUBio modular factory allows biopharmaceutical companies to get their products to market quickly so they can respond rapidly to local healthcare needs,” says Kieran Murphy, chief executive and president of GE Healthcare Life Sciences. While most biotech factories are still built using conventional methods and based on stainless-steel equipment, the KUBio modules arrive 80 percent to 90 percent pre-equipped. The units include heating, ventilation and air handling systems, the clean room, most of the utility equipment, and all of the piping needed to run the plant The Chinese government is targeting biotechnology as part of its efforts to shift its manufacturing away from low-cost goods to high-value, high-tech products. In fact, the Chinese pharma company JHL Biotech opened its own KUBio plant in May in Wuhan, China. Of the top 10 therapeutics on the market today, seven are biopharmaceuticals, according to Genetic Engineering & Biotechnology News. These drugs are about to become even more commonplace — more than 5,000 biologic drug candidate products are in development. [1] The global market for these medicines is more than $170 billion and is growing 15 percent to 18 percent annually. [2] Biologics include synthetic insulin as well as medicines that battle rheumatoid arthritis, cancer and other diseases.  Source: BIOPLAN ASSOCIATES, INC, Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, Apr 2012) https://www.ge.com/news/reports/pfizer-will-use-ges-modular-factory-to-make-next-generation-drugs-in-china ………….. fizer, a leader among global biopharmaceutical companies, has been established in China since the 1980s. Pfizer’s presence and activities in China started with commercial offices and has evolved to include manufacturing (e.g., several plants commenced operations in China during the 1980s and 1990s, including Dalian and Suzhou), as well as R&D – with the establishment of Pfizer’s China R&D Center (CRDC) in Shanghai in 2005. The last decade has seen a significant expansion of Pfizer’s R&D footprint, facilities and capabilities, notably with the launch of CRDC’s sister satellite R&D site in Wuhan in 2010. Currently the market leader among multinational biopharmaceutical companies in China, Pfizer has approximately 1,500 R&D colleagues working in China, with a concentration in three key sites affiliated to CRDC – namely Shanghai, Wuhan and Beijing. CRDC supports Pfizer’s global biological and chemical pharmaceutical R&D programs across our clinical development pipeline, and serves as an important hub of Pfizer global and Asia-Pacific R&D activities. As such, CRDC is an integral part of Pfizer’s global R&D site network, providing support across many R&D disciplines, including clinical drug development, medical, regulatory and safety. CRDC has continually contributed to the biopharmaceutical R&D environment in China to promote the R&D of innovative medicines in China. We have partnered on many collaborative efforts with leading academic institutions and universities, including Peking University, Tsinghua University, Fudan University, and the China Academy of Sciences. CRDC has sponsored, chaired and presented at many external workshops, industry and academic conferences in China, including multiple workshops for the Center of Drug Evaluation (CDE) and Center of Drug Re-Evaluation (CDR) of the CFDA, on clinical pharmacology and pharmacometrics, pharmacovigilance and safety reporting, data mining, clinical data management, among other areas. CRDC’s aspiration is to help accelerate China’s transition to an innovative economy by catalyzing the upgrade of local R&D capabilities, systems, technologies/IP, and culture, to address unmet medical needs, and create a world-class biopharmaceutical R&D ecosystem for China, as part of the global R&D community. https://www.pfizer.com.cn/research/about_china_rd_center_en.html ..... see also https://balance10.blogspot.com/2021/10/pfizer-r-d-building-at-wuhan-china.html

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