product datasheets, catalogs, app notes
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Sterilizing Grade Filtration Unit Operations For Plasmid DNA Processes
11/19/2020
The large size of pDNA can present a challenge for sterile filtration unit operations within your gene therapy manufacturing since the product can be retained by the filters, leading to both yield loss and low filtration capacity. Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!
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Chromatographic Purification Of Plasmid DNA
11/19/2020
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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How Pattern Search Finds Anomaly Patterns In Historical Machine Data
10/21/2020
Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools.
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Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis
10/14/2020
A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.
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Cell And Gene Therapy Definitions For Raw Materials, Starting Materials, Drug Substance And Drug Product
8/25/2020
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components.
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Optimization, Validation And Implementation Of Retroviral Retentive Filters For Production of Adeno-Associated Virus (AAV)
8/19/2020
Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter.
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Considerations For Development Of A Platform Lentivirus Harvest Clarification Process For Cell And Gene Therapy
4/27/2020
One of the new technologies emerging in the biotech manufacturing market is the use of viral vectors for cell and gene therapy. One commonly used viral vector in this space is lentivirus, due to its robustness to package and deliver target DNA. This work explores a variety of lentivirus harvest clarification options and items for consideration during manufacturing platform development of viral therapy production using suspension cell lines.
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High Yield And Functionality In The 3 L Mobius Stirred Tank Bioreactor
3/17/2020
Stemline® XF MSC Medium promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality.
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Benzonase® endonuclease Safety Plus Emprove® Expert Data Sheet
1/15/2020
Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.
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Robust, Load Independent Viral Clearance In MAb Purification
11/15/2019
How the Natrix Q chromatography membrane overcomes diffusion and binding capacity limitations and improved cost efficiency in a study measuring the removal of 4 model viruses.