Bioprocessing White Papers
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Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
6/21/2023
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Calculating Your Business Case For Continuous Manufacturing
6/16/2023
Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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How Can DOE Help Optimize Your Purification Workflow?
6/9/2023
Improve your downstream purification process and utilize design of experiments (DOE) to help in selecting appropriate chromatographic techniques and account for variation among mAbs.
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The Business Case For Pharmaceutical Continuous Manufacturing
6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Pharma Research, Development, & Launches Save Lives — & The Earth
6/1/2023
Understand how a defined framework and way of measuring allows companies to align priorities, short- or long-term goals, and what ESG success looks like.
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The Growth Of Sterile Injectables
6/1/2023
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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Modeling The Economics Of Vaccine Manufacturing
5/26/2023
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Improve Your Molecular Cloning Process With Synthetic Biology Automation
5/25/2023
Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.
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Fc-fusion Cell Line Development: Expression And Analytical Strategies
5/15/2023
Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.