Development & Manufacturing White Papers & Case Studies
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EAD-Based Middle-Down Workflow Analysis
9/21/2023
How can a single-injection, EAD-based middle-down workflow leverage accurate mass measurement, information-rich EAD fragmentation and automated data analysis to offer confident sequence confirmation.
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Driving Efficiency In QC Labs
9/21/2023
Here, we examine the cause and impact of common errors in Quality Control (QC) labs, the strategy for reducing those errors with an intuitive chromatography system, and more.
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CE-SDS Analysis Of Etanercept Using The BioPhase 8800 System
9/21/2023
In this study, a system with multi-capillary capabilities was used to analyze etanercept by bapillary electrophoresis-sodium dodecyl sulfate (CE-SDS).
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CAPA Management Improvement Process
9/15/2023
Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.
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Accurate HC-LC Pairing And A Close-To-Nature Solution For bsAbs
9/11/2023
Examine how a proprietary technology ensures high levels of accurate HC-LC pairing without detriment to critical quality attributes such as titer, binding affinity, stability, and immunogenicity.
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mRNA-LNP Nucleic Acid Assessment From Distinct Formulations
9/8/2023
Review a showcase of a high throughput robust analysis for nucleic acid integrity and size assessment of mRNA-LNP samples using a multi-capillary system and purity and integrity analysis kit.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Structural Characterization Of The Cationic LNP Component
8/31/2023
Gain a deeper understanding of how EAD is used when characterizing ALC-0315 and its impurities, as well as identify the nature and site of chemical alterations in ALC-0315 resulting from forced degradation.
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Comprehensive Peptide Mapping Of Protein Therapeutics
8/31/2023
Explore how the peptide mapping workflows templates provided by a software designed for the characterization of biotherapeutic digests alongside data visualization and interrogation.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.