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HPLC for Characterization and Quality Control of Therapeutic Monoclonal Antibodies
Monoclonal antibodies (mAbs) are highly complex recombinant proteins used successfully as therapeutics in many disease indications. Myriad analytical techniques are required to characterize and control the quality of these molecules during their clinical development and commercial production. Here we describe recent advances and best practices in high performance liquid chromatography (HPLC) analysis of intact mAbs and their variants and fragments. |
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On Demand Webinar: 2D HPLC in Pharmaceutical Analysis |
Two-dimensional HPLC (2DLC) in pharmaceutical research is growing increasingly important due to recent advances and commercialization of hardware software and new column technologies. 2DLC greatly enhances the separation power and has been applied to resolved peak co-elution, impurity quantification, peak purity assessment, stability indicating method development, chiral separation, and more. View this on-demand webinar to learn how Genentech tackles these challenges. Learn more |
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Featured Article |
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Quality Control of Dietary Supplements - Chromatographic Approaches for CGMP Compliance |
The dietary supplement industry has grown to become a multibillion-dollar-a-year market. Concurrent with this growth, the FDA has implemented new current good manufacturing practices (cGMP) regulations (21 CFR part 111) that mandate appropriate quality control and process control testing for dietary supplements, from incoming materials to finished goods. Click here to view the on-demand webinar and download the complimentary infographic. |
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Resources for Pharma Analysis & Mass Spectrometry
We all know that pharmaceutical analysis is full of complexity. The Chromatography Solution Centers, developed by LCGC in coordination with a leading supplier, can help — by providing a variety of articles, application notes, videos, and other resources — updated monthly. This month's offering includes: Mass Spectrometry Solution Center & Chromatography Solution Center |
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Critical Choices in HPLC
In chromatography, the better your understanding of the fundamental mechanisms, the easier it will be for you to develop successful methods. This new e-book provides a guide to essential information in HPLC. Download PDF |
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