Search results for " security of supply"
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Developing oligonucleotide therapeutics with confidence
In this video, we will look at key considerations for oligo therapeutic developers entering the market, such as scalability, flexibility, regulatory concerns, insource/outsource consideratio…
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What Makes a High-Quality Chromatography Resin?
Learn the process of what makes a high-quality chromatography resin.
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Cytiva and Pall Corporation Investing 1.5 Billion USD Over Two Years to Meet Growing Demand for Biotechnology Solutions
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An ongoing strategic growth plan from Cytiva and Pall Corporation, part of the Danaher (NYSE: DHR) Corporation, will expand manufacturing capacity and services acros…
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HyClone Characterized FBS – Origin Equivalence Study
FBS from a single origin may be limited, so qualifying FBS from other origins is one way to enhance security of supply. With that in mind, we evaluated HyClone-brand characterized FBS from the United …
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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Taking Prepacked Columns to Manufacturing Scale
Prepacked chromatography columns in biomanufacturing can save time, but also present concerns related to delivery lead times, capacity, and operational cost.
Learn more here about ways to address…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
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Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …