BPI White Papers

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Characterization and Engineering Performance of the Allegro™ STR 2000 Single-Use Stirred Tank Bioreactor

Process performance in bioreactors is strongly influenced by the efficiency of bulk fluid mixing and the oxygen mass transfer coefficient (kLa). The success of traditional stainless steel STR systems lies in their direct impeller driven agitation that can deliver a wide range of specific power inputs to the fluid. The Allegro™ range of single-use stirred tank bioreactors has adopted this direct driven impeller technology, which allows a wide range of specific power inputs to be achieved. In addition, modifications to…

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The Standardization of Single-use Components for Bioprocessing

As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology. This paper discusses standardization in…

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New Genderless Sterile Connection Technology – A Quality By Design (QbD) Approach For Greater Sterility Assurance From Manufacturing To Use

Single-use pre-sterilized systems can potentially offer a higher level of sterility assurance and a lower risk of product contamination by eliminating some of the operational procedures of traditional processing. The importance of this benefit was highlighted by the FDA’s product recalls in 2015 where 78% of recalls were attributed to lack of sterility assurance or to contamination of the drug product, with the primary reason being failure to follow written procedures. A key requirement for multi-component, single-use sterile systems is…

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Pegasus™ Prime: Robust Retention after Pressure Interruptions (Stop and Start)

Virus filtration is a vital part of the viral clearance strategy in bioprocesses. In filtration, size exclusion mechanisms are orthogonal to other inactivation or removal techniques and target the physical dimensions of the virus to achieve a high degree of virus reduction. Any flow or pressure interruption during filtration has been shown to increase the risk of virus passage. This application note reviews the PegasusTM Prime virus removal filters and demonstrates robust, high viral clearance in the presence of prolonged…

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MiniTEM speeds up ‘time-to-insight’: automated purity analysis of two different Adenovirus samples

MiniTEM™ is a low-voltage transmission electron microscope system designed for nanoparticle characterization. The high-quality images it acquires reveal particle morphologies that can be transformed into accurate metrics. A metric for sample purity based on the ratio of the total area of debris to that of intact Adenovirus particles is presented in this study. The automated analysis that MiniTEM offers encompasses a far larger number of particles compared with studies performed manually using conventional electron microscopy, resulting in accurate and statistically…

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A summary of how to develop a cell therapy from concept to market authorization

Cell therapies offer new opportunities for the treatment of disease and injury but considerable infrastructure and a complex range of activities and expertise are required to translate a promising cell therapy product into clinical use. Suppliers, developers, regulators, and care givers need to interact cooperatively in order to bring therapies to patients in the most efficient, safe, and economically viable way and GE Healthcare is working with the Karolinska University Hospital to investigate more effective routes for bringing potential cell…

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An Example of Evaluation of protein A Multicolumn Processes for the Capture of Large-Volume, High Concentration Bioreactors, Based on BioSC® Predict Optimization Software

The present paper provides some recent data regarding the optimization of BioSC® processes using three commercially available protein A resins, based on the BioSC® Predict software. A rapid description of the first steps to develop a multi-column process guided by simulation is provided to avoid generating unrealistic conclusions. Other approaches could however be applied depending on the objectives targeted. Examples of multicolumn systems based on three commercially available protein A resins are also provided, for the purification of a 15,000-L…

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How to Boost Profits with Single-Use Powder Transfer in Biopharmaceuticals Manufacturing

For many years, media and buffer ingredients used in powder form were transferred from stock containers using open scoops, weighed and mixed in buckets or open-top bags, and then carried in and dumped from those buckets or open-top bags directly into production vessels—based on the premise that sterility wasn’t required at that early stage of manufacturing. While much of this process was often carried out in a separate room from the production line to contain airborne contaminants, final transfer to…

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Fast monoclonal antibody titer determination with the TSKgel® Protein A-5PW column

The antibody therapeutics market is enjoying high growth rates, the major areas of therapeutic application being cancer and immune/inflammation-related disorders. Six of the top ten best-selling global drug brands are monoclonal antibody-based. This market is predicated to show continued growth for many years to come, with more monoclonal antibodies (mAbs) designed and produced for treatments of specific diseases. Early in mAb development there are many harvested cell supernatant samples which contain mAbs that are secreted by cell cultures. These samples…

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Getting Big Benefits from Small Components

Like a chain, a biopharma transfer system depends on each of its links being strong enough to protect the integrity of the materials being transferred. In order to prevent problems associated with contamination, the system must be able to maintain a pure environment. Container closures and stopper systems are sometimes seen as small items, but choosing the right components is vital. The impact of specifying the appropriate closure or stopper system can be felt throughout an entire fluid transfer process.…