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ACCELERATING AND STREAMLINING DOWNSTREAM PROCESS DEVELOPMENT
September 25-28, 2017
Hynes Convention Center,
Boston, MA
About the Whitepaper
Some estimates target the worldwide market of monoclonal antibodies (mAb) with the projected approval rate of four per year, on the order of $125 billion by 2020. Besides, several immunotherapies originated in the 1980’s, and 1990’s are to end their patents in the next few years. That is going to draw capital to the production and commercialization of biosimilars. While the role of biologics in treating human diseases has evolved substantially over the past decade so has the technology to produce and the role of the manufacturing process on the structure and activity of the molecule.
This report discusses how to speed up the development and streamline up and downstream processing. You will see those opportunities at close reach to further increase speed to the clinic and accelerate biologicals purification processes.
You will find answers to the following questions: Are scaled-up, and budget operations with the predominant downstream processing (DSP) operations fit for a challenging market? Does DSP with state-of-the-art purification methods warrant biotherapeutics regulatory clearance? Does shifting processes from batch to continuous manufacturing pose unnecessary financial risks? Production processes for biopharmaceuticals using protein A chromatography still suffer from platform limitations. How can we overcome those setbacks and the high operation expenses associated?