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Enable Technical Excellence in Development and Manufacturing of Biologics 

Company

BioGENEXUS, LLC, was formed in 2012 by founder Dr. Steven S. Lee in Arizona. It was intended to provide consulting services based on his broad-spectrum experience and expertise in CMC for biologics to support and enable biotech companies in development of novel and follow-on biologics or biosimilars. To date, BioGENEXUS has led and supported directly many biotech startup companies including the filing and launch of the very first biosimilar and the startup of biologics business in China; commercialization of multiple biosimilars in India; buildup of CDMO business in Singapore; transformation of biotech company from development to CDMO service provider in Taiwan.

Services and Technology

Global CMC & business consulting services for biologics

  • Executive For Hire: Serve as acting CXO of challenged companies to lead changes

  • Build C-Suite Executive Team to transform companies in highly challenging situations

  • Grow/expand businesses via M&As, fund raising, business development

  • Construct strategic CMC capacity & capability planning

  • Support global regulatory CMC filings for biologics

  • Provide innovative solutions for highly challenging CMC issues

  • Engage business development and investment in Asia

  • Mentor/Coach high potential leaders and managers

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​Disruptive technology development for biopharmaceutical industry

  • Develop disruptive technology platforms for manufacturing biologics

  • Enable integrated continuous manufacturing of biologics

  • Provide trademarks for licensing of specific novel biologics and biosimilars

  • Develop novel analytics essential for fully automated chemical processing 

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Trade Marks

A continuous manufacturing platform for producing biologics including monoclonal antibodies which integrate upstream intensified perfusion animal cell culture and downstream crystallization purification enabling fully automated continuous operations.  This disruptive platform presents an integrated continuous manufacturing process which is much simpler and cost-effective than current fed-batch process employing multiple chromatography steps inherently batch-mode operations by nature. 

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A biologics product or a group of biologics products of a class of therapeutic proteins which consists of only single, or singular product molecular structure, as compared to existing commercial products composed of a mixture of highly complex and variable molecular species mainly attributed to biological nature of cell culture or cell lines.

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Meet Dr. Steven Lee

30+ years of experience in biologics development & manufacturing and executive leadership

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CEO and Founder, BioGENEXUS, LLC: Global biotech consulting & advisory company providing broad experience & entrepreneurial leadership in global business development, strategic planning, biologics CMC, disruptive manufacturing technology, executive mentor/coaching, acting CXO

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Global Biopharmaceutical Companies in USA [Developed Markets]:

  • Bristol-Myers Squibb Company, VP & GM, Biologics Manufacturing & Process Development; Head, Global Biotech Center of Excellence, built large scale plant in MA to establish franchise & launched internally developed antibodies, Orencia®, Nulojix®, Yervoy®

  • Merck & Co., Inc. & Co., Director/Program Leader. Bioprocess development & biologics manufacturing, fermentation & cell culture-derived commercial products including antifungal agent (Cancidas®) & vaccines of 100+ images: ProQuad®, MMR-II-V®  & VARIVAX PU®

  • Hoffman-La Roche, Inc., Senior Scientist & PM. Commercialized a-Interferon (Roferon-A®)

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Biotech startup ventures in SE Asia [Emerging Markets]:

  • Dr. Reddy’s Laboratories [NYSE], Global Head, Biologics Technical Operations [India] & CEO/Board, Singapore Operations [Singapore]. Leading biosimilar unicorn in Asia, launched & supplied world’s first 4 biosimilars: Reditux®, Cresp® ,Grafee® (Filgrastim), PEG Grafeel®.

  • Luye Pharma Group [SEHK], Global Head, Biologics Business. Developed first 3 biosimilars

  • A-BIO Pharma [Singapore government/MIT], CEO & BOD. Pioneering cell culture-based CDMO for global bio-pharmas.  Aimed to build Singapore’s biotech industry

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  • Ph.D. - Biochemical Engineering Massachusetts Institute of Technology, USA

  • MS - Chemical Engineering The University of Michigan, USA

  • BS - Agricultural Chemistry National Taiwan University, Taiwan

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Contact Us

Address

1938 East Osborn Road
Phoenix, AZ 85016, USA

Contact

1-623-241-2040

Opening Hours

Mon - Fri

8:30 am – 5:30 pm PST

Email: BioGenexuspt@gmail.com

Wechat, LINE, Whatsapp: ID sslbear

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