T he cell therapy industry (CTI) is poised to grow rapidly over the next decade, treating millions of patients and generating annual revenues into the tens of billions of US dollars (1, 2). To meet that high-growth demand, large CTI system manufacturers (e.g., Corning, Nunc/Nalgene, and GE Healthcare) and leading contract manufacturing organizations (CMOs, such as Lonza) are developing and inte...

Chromatography has become an indispensable tool for the purification of proteins. Since the regulatory demands on protein purity are expected to become stricter, the need for generating improved resins for chromatographic separations has increased. More advanced scientific investigations of protein structure/function relationships, in particular, have also been a driving force for generating mo...

2015 The commercial potential of monoclonal antibodies (mAbs) has been continuously increasing during the last years alongside with the number of approved mAb-based drugs and clinical trials. Despite their effectiveness and safety, the general access to this class of biopharmaceuticals is barred by high selling prices. Downstream processing is now considered the bottleneck in the manufacturing ...

The microbial exopolysaccharides are water-soluble polymers secreted by microorganisms during fermentation. The biopolymer gellan gum is a relatively recent addition to the family of microbial polysaccharides that is gaining much importance in food, pharmaceutical and chemical industries due to its novel properties. It is commercially produced by C. P. Kelco in Japan and the USA. Further resear...

AIM To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. MATERIALS & METHODS A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. RESULTS Tangential flow filtration was generally more cost-effective for the lower...

Plants offer the tantalizing prospect of low-cost automated manufacturing processes for biopharmaceutical proteins, but several challenges must be addressed before such goals are realized and the most significant hurdles are found during downstream processing (DSP). In contrast to the standardized microbial and mammalian cell platforms embraced by the biopharmaceutical industry, there are many ...

An ever increasing focus is being placed on the manufacturing costs of biotherapeutics. The drive towards continuous processing offers one opportunity to address these costs through the advantages it offers. Continuous operation presents opportunities for real-time process monitoring and automated control with potential benefits including predictable product specification, reduced labour costs,...

s of Papers, 232nd ACS Meeting, San Francisco, CA, 2006. Yigzaw, Y. , Piper, R. , Tran , M. , Shukla , A.A. ( 2006 ). Exploitation of the adsorptive properties of depth filters for host cell protein removal during monoclonal antibody purifi cation. Biotechnology Progress 22, 288–296. Roque, A.C.A. , Silva, C.S.O. , Taipa, M.A. (2007). Affi nit...

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