Pharmaceutical bioprocessing 

About: Pharmaceutical bioprocessing is an academic journal. The journal publishes majorly in the area(s): Chinese hamster ovary cell & Biomanufacturing. It has an ISSN identifier of 2048-9145. Over the lifetime, 191 publications have been published receiving 1435 citations.

On the way to commercializing plant cell culture platform for biopharmaceuticals: present status and prospect.

Abstract: Plant cell culture is emerging as an alternative bioproduction system for recombinant pharmaceuticals. Growing plant cells in vitro under controlled environmental conditions allows for precise control over cell growth and protein production, batch-to-batch product consistency and a production process aligned with current good manufacturing practices. With the recent US FDA approval and commercialization of the world's first plant cell-based recombinant pharmaceutical for human use, β-glucocerebrosidase for treatment of Gaucher's disease, a new era has come in which plant cell culture shows high potential to displace some established platform technologies in niche markets. This review updates the progress in plant cell culture processing technology, highlights recent commercial successes and discusses the challenges that must be overcome to make this platform commercially viable.

Developability assessment as an early de-risking tool for biopharmaceutical development

Abstract: Increasing attrition of therapeutic candidates during preclinical and clinical development affects productivity and causes spiraling costs, negatively impacting the development of new treatments. For biopharmaceuticals, product design, lead selection and manufacturing process development constitute significant areas of risk because of their decisive influence on product quality, biological activity and safety, as well as cost of goods. Risk-management developability assessments, introduced early on in development, can help identify and address potential causes of attrition in preclinical and clinical stages related to product manufacturing, safety, delivery and efficacy issues. This article discusses the utilization of in silico and in vitro surrogate assays early on in development as part of a comprehensive developability assessment for novel biotherapeutics, incorporating a closer interaction between discovery and development functions. It further suggests how such approaches can have a significant impa...

Computational fluid dynamics as a modern tool for engineering characterization of bioreactors

Abstract: Since design, construction and evaluation of bioreactors for large-scale production is costly and time consuming, computational methods may give some insights into the fluid mechanics within bioreactors. Thus, critical limiting factors, such as insufficient mixing as well as inhomogeneous nutrient and oxygen mass transfer, may be identified early in the design process. Although advanced experimental techniques such as laser Doppler anemometry and particle image velocimetry are also reliable, they are too time consuming to characterize the complete flow pattern in industrial scales and rely on optical accessibility. Therefore, the knowledge of flow characteristics provided by computational fluid dynamics (CFD) is indispensable for the rational design of bioreactors. Based on previously published reviews, the present work summarizes the latest publications on the usage of CFD to characterize and scale-up bioreactors used in biotechnological processes. Selected models that are used to predict the fluid flow pattern and key engineering parameters of commonly used bioreactors are described. Related issues, such as grid dependency of CFD results and the requirement for experimental verification are also addressed. Finally, an overview of proposed but not yet feasible CFD applications is presented, including fluid–structure interaction, the use of direct numerical simulation and the coupling fluid flow and chemical reactions.

Production and purification of the multifunctional enzyme horseradish peroxidase.

Abstract: The oxidoreductase horseradish peroxidase (HRP) is used in numerous industrial and medical applications. In this review, we briefly describe this well-studied enzyme and focus on its promising use in targeted cancer treatment. In combination with a plant hormone, HRP can be used in specific enzyme–prodrug therapies. Despite this outstanding application, HRP has not found its way as a biopharmaceutical into targeted cancer therapy yet. The reasons therefore lie in the present low-yield production and cumbersome purification of this enzyme from its natural source. However, surface glycosylation renders the recombinant production of HRP difficult. Here, we compare different production hosts for HRP and summarize currently used production and purification strategies for this enzyme. We further present our own strategy of glycoengineering this powerful enzyme to allow recombinant high-yield production in Pichia pastoris and subsequent simple downstream processing.

The impact of continuous multicolumn chromatography on biomanufacturing efficiency

Abstract: Over the past few years, the capacity bottleneck in biomanufacturing has shifted from the upstream process to the purification process. In particular, capture chromatography steps have become a limiting factor in facility throughput. This is a direct result of the discrepancy between expression levels, which have increased by a factor of ten, and the capacity of biochromatography media, which has at best doubled. Continuous countercurrent multicolumn chromatography is a promising approach to deal with the capacity bottleneck, particularly if designed in a single-use format. BioSMB™ technology is a disposable bioprocess technology that allows standard capture chromatography steps, such as Protein A capture, to be executed with much less installed chromatographic media using a multicolumn chromatography process. This allows an economically favorable, single-use option where none has previously been available. Various case studies have demonstrated the advantages of this technology for various separations. I...