• Introduction and clearance of beta‐glucan in the downstream processing of monoclonal antibodies

    1 month ago - By Wiley

    Abstract
    β‐Glucan process‐related impurities can be introduced into biopharmaceutical products via upstream or downstream processing or via excipients. This study obtained a comprehensive process‐mapping dataset for five monoclonal antibodies to assess β‐glucan introduction and clearance during development and production runs at various scales. Overall, 198 data points were available for analysis. The greatest β‐glucan concentrations were found in the depth‐filtration filtrate. Load volume correlated with β‐glucan concentration in the filtrate, whereas flush volume was of secondary...
    Read more ...

     

  • Development of an activated carbon filtration step and high throughput screening method to remove host cell proteins from a recombinant enzyme process

    1 month ago - By Wiley

    Abstract
    An increasing number of non‐mAb recombinant proteins are being developed today. These biotherapeutics provide greater purification challenges where multiple polishing steps may be required to meet final purity specifications or the process steps may require extensive optimization. Recent studies have shown that activated carbon can be employed in downstream purification processes to selectively separate host cell proteins from monoclonal antibodies. However, the use of activated carbon as a unit operation in a cGMP purification process is relatively new. As such, the goal of this...
    Read more ...

     

  • Expression of NLRP3 inflammasome proteins in ExpiCHO‐S mammalian cells reveals oligomerization properties that are highly sensitive to solution conditions

    1 month ago - By Wiley

    ABSTRACT
    The NLRP3 inflammasome is a key intracellular component of the innate immune response. It is a 3‐protein complex essential for the production of mature interleukin 1‐β. The complex, which is comprised of three proteins, NLRP3, ASC, and pro‐caspase‐1, has been implicated in the physiological response to pathogenic elements of cardiovascular disease and Alzheimer's disease. Investigations into the properties of the three proteins can be aided by larger‐scale recombinant expression to produce adequate amounts. In the current study, a variety of NLRP3 inflammasome proteins were...
    Read more ...

     

  • Characterization of soy protein hydrolysates and influence of its iron content on monoclonal antibody production by a murine hybridoma cell line

    1 month ago - By Wiley

    Abstract
    A challenging aspect with the use of protein hydrolysates in commercial manufacturing processes of recombinant therapeutic proteins is their impacts on the protein production due to a lack of understanding of batch‐to‐batch variability. Soy hydrolysates variability and its impact on fed‐batch production of a recombinant monoclonal antibody expressed in Sp2/0 cells were studied using 37 batches from the same vendor. The batch‐to‐batch variability of soy hydrolysates impacted cell growth, titer and product quality. Physicochemical characterization of batches confirmed that soy...
    Read more ...