Insights On Polish & Viral Filtration

  1. Ensuring Everything is A-OK At AKBA 9/2/2020

    With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical their equipment and systems meet the strict operational needs of the manufacturing systems used by their clients.

  2. 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.

  3. Eshmuno® CMX — A Novel Mixed Mode Cation Exchange Resin For The Purification Of Glycoproteins 6/29/2020

    With the outbreak of COVID-19, the most severe pandemic in the 21st century so far, a feverish search for therapeutic treatment and vaccinations has just started. A substantial number of approaches are focusing on the coronavirus S glycoprotein, a surfaceexposed protein that mediates the entry of the virus into the host cells. The aim of this technical note is to provide a description of the capture and subsequent purification of glycoproteins.

  4. Is Your Complex Formulation Process Set Up For Success? 10/1/2019

    A formulation is considered complex if it requires additional steps beyond simple mixing and filtration. Discover six major types of complex formulations as well as the necessary equipment and processes to develop GMP-compliant formulations.

  5. Virus Reduction Of An Affinity Capture Step: Viral Clearance For Protein A 5/17/2019

    Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.

  6. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  7. Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins 8/3/2016

    Native and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.

  8. Selecting The Optimal Resins For Endotoxin Depletion In Process Purification 8/3/2016

    A guide to effectively remove endotoxins with versatile process resins.

  9. Downstream Protein Purification 7/27/2016

    Bio-therapeutic manufacturing requires precise control of process parameters throughout production to ensure high yield and high quality products that are safe for patient use.

  10. Development Of An Efficient Manufacturing Process For Adenovirus 7/14/2016

    Here, we present purification results of a process developed for the manufacturing of a recombinant adenovirus. This two-column process results in an adenovirus preparation comparable to clinical grade products, with high yield and very low host cell protein (HCP) and DNA contamination.