Biosimilar Manufacturing solution center
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Manufacturing Challenges With High Concentration Biologics
3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A New Model Approach To Drug Shortage Prevention
3/15/2024
The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.
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Doubling Down On Biopharma’s Growing Skills Drought
3/13/2024
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
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Sterilizing Grade Filter Performance With Biologic Drugs
3/11/2024
Here, we analyze the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins and demonstrate how filter selection can impact your process.
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Getting To Know MAM, The New Quality Control Strategy On the Block
3/11/2024
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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Exosome Isolation By TFF And Size Exclusion Chromatography
3/6/2024
Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.
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A Scalable Single-Use Two-Step pDNA Purification Process
3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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High-Titer rAAV Production In Bioreactors Using Producer Cell Lines
3/6/2024
Here, we detail the upstream process development and optimization for an AAV8-GFP proof-of-concept (PoC) producer single cell clone (SCC) in both batch and perfusion modes.
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Safer AAV Through Reduced Host-Cell DNA Encapsidation
3/6/2024
While most hcDNA molecules outside AAV particles can be eliminated during downstream processing, encapsidated hcDNA molecules remain largely undetectable. Learn how to overcome this critical issue.