A novel high-throughput process development screening tool for virus filtration

Tang, Alison; Ramos, Irina; Newell, Kelcy J.; Stewart, Kevin D.

doi:10.1016/j.memsci.2020.118330

Cited by 10 publications

(8 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In terms of available HTPD tools for viral inactivation and viral clearance, even though the participants indicated to be a considerable gap in development, recent studies have been published demonstrating the potential of developing a virus filter micro‐scale HTPD model. Tang et al ( 2020 ) used, in combination with an automated liquid handling system, a 96‐well filter plate to assess its suitability to be a novel microscale HTPD scaledown model. With these types of tools, HT virus filtration optimization is now an option, enabling rapid process development for continuous biomanufacturing.…”

Section: State‐of‐the‐art In Continuous Biomanufacturingmentioning

confidence: 99%

“…Filtration process development usually needs a large amount of materials and time‐consuming work. The use of HTS equipment for such a system emphasizes on reducing reagent consumption in process development while avoiding the oversizing of equipment, the consequence of a poorer process knowledge (Tang et al, 2020 ).…”

Section: Current Needs In the Integrated Continuous Bioprocessingmentioning

confidence: 99%

“…considerable gap in development, recent studies have been published demonstrating the potential of developing a virus filter micro-scale HTPD model Tang et al (2020). used, in combination with an automated liquid handling system, a 96-well filter plate to assess its suitability to be a novel microscale HTPD scaledown model.…”

mentioning

confidence: 99%

See 2 more Smart Citations

White paper on high‐throughput process development for integrated continuous biomanufacturing

Pedro

Silva

Patil

et al. 2021

Biotech & Bioengineering

View full text Add to dashboard Cite

Continuous manufacturing is an indicator of a maturing industry, as can be seen by the example of the petrochemical industry. Patent expiry promotes a price competition between manufacturing companies, and more efficient and cheaper processes are needed to achieve lower production costs. Over the last decade, continuous biomanufacturing has had significant breakthroughs, with regulatory agencies encouraging the industry to implement this processing mode. Process development is resource and time consuming and, although it is increasingly becoming less expensive and faster through high‐throughput process development (HTPD) implementation, reliable HTPD technology for integrated and continuous biomanufacturing is still lacking and is considered to be an emerging field. Therefore, this paper aims to illustrate the major gaps in HTPD and to discuss the major needs and possible solutions to achieve an end‐to‐end Integrated Continuous Biomanufacturing, as discussed in the context of the 2019 Integrated Continuous Biomanufacturing conference. The current HTPD state‐of‐the‐art for several unit operations is discussed, as well as the emerging technologies which will expedite a shift to continuous biomanufacturing.

show abstract

Section: State‐of‐the‐art In Continuous Biomanufacturingmentioning

confidence: 99%

Section: Current Needs In the Integrated Continuous Bioprocessingmentioning

confidence: 99%

See 1 more Smart Citation

White paper on high‐throughput process development for integrated continuous biomanufacturing

Pedro

Silva

Patil

et al. 2021

Biotech & Bioengineering

View full text Add to dashboard Cite

show abstract

“…flux decay ) can be performed rapidly. Initial work by Tang et al (Tang, Ramos et al 2020) provided a framework for HTPD filter plate screening with recombinant proteins. These tools can rapidly screen out failure mode conditions early in process development.…”

Section: Study Modelsmentioning

confidence: 99%

Viral Filtration: A Review of Current and Future Practices in Bioprocessing

Johnson¹,

Chen

Bolton

et al. 2021

Preprint

View full text Add to dashboard Cite

For drug products manufactured in mammalian cells, safety assurance practices are needed during production to assure that the final medicinal product is safe from the potential risk of viral contamination. Virus filters provide viral retention for a range of viruses through robust, size-based retention mechanism. Therefore, a viral filtration step is commonly utilized in a well-designed recombinant therapeutic protein purification process and is a key component in an overall strategy to minimize the risks of adventitious and endogenous viral particles during the manufacturing of biotechnology products. This review summarizes the history of viral filtration, currently available viral filters and prefilters, and viral filtration integrity test methods and study models. There is also discussion of current understanding and gaps with an eye toward future trends and emerging filtration technologies.

show abstract

“…A high-throughput filtration system has been developed as a screening tool for viruses. This setup is a 96-well plate format, allowing multiple samples to be filtered simultaneously (Tang et al, 2020). The requirement for the fluorescence microscope might be considered another constraint of this method.…”

mentioning

confidence: 99%

Quantitative Imaging of Bacteriophage Amplification for Rapid Detection of Bacteria in Model Foods

Wisuthiphaet

Young

et al. 2022

Front. Microbiol.

View full text Add to dashboard Cite

Rapid detection of bacteria in water and food samples is a critical need. The current molecular methods like real-time PCR can provide rapid detection after initial enrichment. However, these methods require significant preparation steps, specialized facilities to reduce contamination, and relatively expensive reagents. This study evaluates a novel approach for detecting bacteria based on imaging of bacteriophage amplification upon infection of the target host bacteria to mitigate some of these constraints and improve the specificity of discriminating live vs. dead bacteria. Thus, this research leverages the natural ability of lytic bacteriophages to rapidly amplify their genetic material and generate progeny phages upon infecting the host bacterium. This study uses a nucleic acid staining dye, a conventional fluorescence microscope, and quantitative image analysis for imaging the amplification of bacteriophages. The sensitivity and assay time for imaging-based quantification of phage amplification for detecting Escherichia coli were compared with RT-PCR and the standard plaque-forming assay for detection phage amplification in model systems, including coconut water and spinach wash water. The results demonstrate that the imaging approach matches both the sensitivity and speed for detecting E. coli using the RT-PCR method without requiring isolation of nucleic acids, expensive reagents, and specialized facilities. The quantitative imaging results demonstrate the detection of 10 CFU/ml of E. coli in coconut water and simulated spinach wash water with a chemical oxygen demand (COD) of 3,000 ppm within 8 h, including initial enrichment of the bacteria. In summary, the results of this study illustrate a novel phage amplification-based approach for detecting target bacteria in complex food and water samples using simple sample preparation methods and low-cost reagents.

show abstract

A novel high-throughput process development screening tool for virus filtration

Cited by 10 publications

References 12 publications

White paper on high‐throughput process development for integrated continuous biomanufacturing

White paper on high‐throughput process development for integrated continuous biomanufacturing

Viral Filtration: A Review of Current and Future Practices in Bioprocessing

Quantitative Imaging of Bacteriophage Amplification for Rapid Detection of Bacteria in Model Foods

Contact Info

Product

Resources

About