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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Worldwide Therapeutic Protein Production Capacity

    Abstract

    This chapter describes the worldwide market size and capacity for biopharmaceutical manufacturing. This includes number of companies, total capacity for mammalian and microbial systems, fill finish operations, and other data such as clinical production capacity. There are a total of 288 companies operating GMP compliant facilities manufacturing biopharmaceutical products for clinical trials and inmarket supply located in the UK, Europe and the US. This total includes both primary manufacturing (i.e. mammalian/microbial cell culture and purification) and secondary manufacturing (i.e. aseptic liquid fill and freeze drying). Of the companies analyzed, many are involved in primary manufacturing. The majority of manufacturing capacity resides in the Europe and US with a small but growing amount located in Asia. It should be noted that this analysis excludes Asian companies which manufacture for their local market. The situation in Asia is changing rapidly, and there have been a number of announcements in the last year indicating significant investment in GMP manufacturing capacity in Asia. Some examples include Celltrion in South Korea and the recently announced investments in Singapore by Novartis, Lonza, and Genentech.

    About the Authors

    Andrew Sinclair, Co-Founder, Managing Director, BioPharm Services UK
    Andrew has over 20 years design experience in the biopharmaceutical industry, from the first recombinant insulin process through to large-scale monoclonal antibody manufacturing. He has had direct experience of and responsibility for manufacturing, logistics, maintenance and capital programme management. Most recently he was Director of Engineering and Logistics at Lonza Biologics. Andrew has an MSc in Biochemical Engineering from University College London. He has published widely and has presented at numerous industry conferences.

    Claire Hill, Bioprocess Engineer
    Claire has experience in financial analysis, market research, and software development. At Biopharm Services she is responsible for market analysis and business development as well as bioprocess modelling. Claire has an MSc in Biochemical Engineering from University College London and an MBA from the University of Notre Dame.


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