Expert Insights On Cell Line Development
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
5/3/2024
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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Cell Counting Is Growing More Important Amid Advanced Therapy's Rise
4/12/2024
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing
2/14/2024
Amid the increasing need for greater volumes of therapeutic molecules, proteins, and viral vectors, a promising technology started to develop — the stable cell line.
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It's Time To Dethrone CHO When It Comes To mAb Production
2/1/2024
Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.
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Novel Approaches For Obtaining High-productivity Clones
1/30/2024
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Developing A Viral Gene Therapy Manufacturing Process
1/23/2024
There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.
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Why Lactococcus Lactis Might Be The Best Membrane Protein Factory
11/17/2023
The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.
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Balanced Sourcing Of Custom Media/Buffer Formulations: The Case For Outsourcing
8/10/2023
Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.
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How To Build Cell Culture Models With Purpose
8/9/2023
Building a successful cell culture model has two key requirements — a clearly defined purpose from the outset and good data that support the purpose. This article discusses aspects to consider when characterizing complex cell cultures through modeling.
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Here's How USP mAb Standards Support Fast-Evolving Platform Approaches
5/24/2023
Industry-accepted reference materials give drug manufacturers a competitive edge. Data shows that first-in-class mAbs hold a market lead over later entrants. This article discusses the benefits of using well-characterized reference materials instead of spending time and resources to develop them from scratch.