INSIGHTS ON UPSTREAM MANUFACTURING

  • Transient Lentiviral Vector Production In HEK 293T Cells Using The BioFlo 320 Control Station With A BioBLU 5p Single-Use Packed-Bed Vessel
    Transient Lentiviral Vector Production In HEK 293T Cells Using The BioFlo 320 Control Station With A BioBLU 5p Single-Use Packed-Bed Vessel

    Lentiviral vectors (LVs), which are especially applicable to gene therapy, are promising vector types for the clinical trials of such treatments. Current bottlenecks in the production of LVs are caused mainly by the disadvantages of classical two-dimensional culture forms. Switching to bioreactors can eliminate those disadvantages and offer the benefits of process automation, tight regulation of production conditions, and reduced labor input. This application note describes the first successful experimental setup to cultivate LVs in HEK 293T cells adherently grown on Fibra-Cel® disks in a BioBLU 5p Single-Use Vessel.

  • Precise Control Of Gas Flows Within The BIOSTAT® B-DCU

    To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.

  • Automated Glucose Control

    Ensuring that the cells do not have too much or too little, enables them to grow fast and maximize the product secretion. Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.

  • UniVessel® Single Use Bioreactor For CHO Fed-Batch Cultures

    The motivation for utilizing single use (SU) bioreactors is the reduced turn-around time and labor required for cleaning and autoclaving traditional glass vessels as well as the associated costs for maintenance and repair.  Sartorius’ 2L UniVessel® SU has an option for an external water jacket system controlled by Sartorius’ BIOSTAT® controllers. In this study, we determined the feasibility of the UniVessel® SU and BIOSTAT® B-DCU II combination by performing detailed comparability studies of cell growth, viability, monoclonal antibody (mAb) productivity and product quality attributes (aggregation, charge variation and glycosylation) using three recombinant CHO cell lines.

  • Closed And Semi-Automated Processing Of CAR T Cells

    Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

  • Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

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UPSTREAM MANUFACTURING MULTIMEDIA

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UPSTREAM MANUFACTURING SOLUTIONS

  • Product Characterization Assay Package - Interlot And Biosimilar Comparability

    Monoclonal antibodies (mAbs) are highly complex biomolecules easily affected by changes in the biopharmaceutical manufacturing process. Something as simple as a temperature fluctuation can produce a change in higher order structure (HOS) that renders the mAb less active or inactive. Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production.

  • Product Characterization Assay Package - Cell Line Development

    Our Product Characterization services offering combines mAb physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug—its critical quality attributes. All testing is performed in a GMP qualified laboratory and is compliant with ICH guidelines, FDA, and EMA regulations.

  • Product Characterization Assay Package - Impurities

    Many different impurities are present in or generated during the mAb manufacturing process. We work to make sure your biotherapy’s development program isn’t derailed by process or product contaminates that can arise from raw input materials, occur as residual processing agents, or formed as reaction by-products.

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