Search results for " biologic" in Articles / App Notes
Article
Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
…eers, and technicians who work in process development and biomanufacturing of biopharmaceuticals and biologics. Through the 25,000-ft2 flexible facility at Spring House Innovation Park in Lower Gwyne…
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Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
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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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Fundamentals of Viral Clearance Studies with a Focus on Chromatography
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This…
Article
Cytiva Announces Digital Collaboration with Amgen To Improve Biomanufacturing Performance Reliability
Cytiva announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability…
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The Good and Bad of Biosimilars
A number of companies have found success in the biosimilars market, having experience in biological drug manufacture, financial muscle, and brand recognition. You will be facing steep competition whil…
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Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
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Modeling the Degradation of mAb Therapeutics
It can, either directly or indirectly, affect mAbs’ biological activity as well as toxicity (4).
The instabilities associated with mAbs can be broadly classified as either physical or chemical…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…tography Techniques: Get the Right Purity/Yield of Protein
• Impurity Testing of Biologic Drug Products
• Tools and Solutions for Separation of Charged mAb Variants
• Modern Manuf…
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Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.