Tuesday, May 24, 2022 Daily Archives

Introduction: Cell-Line Engineering and Development at BPI West

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Critical to the manufacturing of biotherapeutics is development of robust and stable cell lines that express high-quality products in large quantities. Chinese hamster ovary (CHO) cells are the “workhorse” expression host for manufacturing glycoprotein-based therapeutics — from antibodies to enzymes and hormones and beyond — making them the subject of most industry discussion regarding both cell-line development (CLD) and engineering. Most methods, technologies, and strategies apply regardless of the type of protein to be expressed or the type of cells…

May 24, 2022

Genome Editing for Cell-Line Development

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At BPI Europe in April 2019, Dirk Gewert (business unit leader of bioproduction at Horizon Discovery) told BioProcess Insider that Chinese hamster ovary (CHO) cell lines haven’t changed much in the 30 years since they were first used in biomanufacturing (1). Only a few companies offered commercially available, production-ready CHO cell lines for large-scale manufacturing of biotherapeutics. “In all cases,” he said, “cell lines were selected by identifying high-expressing clones and focusing on process optimization to improve expression and other…

May 24, 2022

Cell-Line Development for Expressing IgM Antibodies

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Immunoglobulin G (IgG) antibodies have been studied and applied as biopharmaceuticals for decades, and they remain dominant in the monoclonal antibody (MAb) pipeline. By contrast, immunoglobulin M (IgM) molecules are much larger and consequently more challenging for biomanufacturing and therapeutic application. Essentially, they appear as clusters of the familiar Y-shaped IgG molecules, joined at their bases in pentameric (Figure 1) or hexameric forms. That structure gives them 10 and 12 binding moieties, respectively, which translate to superior binding power (avidity)…

May 24, 2022

Pseudomonas fluorescens: Cell-Line Development of a Commercially Proven Platform for Biopharmaceutical Manufacturing

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A number of factors contribute to delivering a robust, highly productive, and reliable process for manufacturing a therapeutic protein. They begin with a cell-host system and a gene-expression strategy that determine a developer’s ability to optimize growth and expression titers. But for many therapeutic proteins, initial attempts to develop a production process are based on evaluation of limited factors and tend to yield only small quantities or poor product quality. Automation can enable parallel building and expression screening of diverse…

May 24, 2022

Ask the Expert: Analytical Tools to Accelerate Cell-Line Development Workflows

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Cell-line development (CLD) involves screening thousands of clones to identify the most stable and productive candidate for an upstream manufacturing process (Figure 1). Such assessment requires considerable time and resources for preparation and execution of multiple cultivations and analytical assays. In March 2022, Lukas Klein and Dirk Müller (scientist and manager of media and process development, respectively, at Sartorius) delivered a BPI Ask the Expert webinar about integrating their company’s Ambr 15 Cell Culture bioreactor and Octet label-free biolayer interferometry…

May 24, 2022