Lumetics LINK™ was recently referenced in the article “Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations” by Zahir Akhunzada of Bristol Myers Squibb (BMS), which was published in the industry journal Current Pharmaceutical Biotechnology.
LINK was used to separate proteinaceous from the rest of the particulates in MFI-generated data of a protein sample. View the abstract below and get more information on PubMed.gov.
ABSTRACT: Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations
AUTHORS: Akhunzada ZS1,2, Hubert M3, Sahin E4, Pratt J5.
Background: The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability. Methods: The current compendial method based on light obscuration (LO) has limitations in the analysis of translucent/low refractive index particles. A number of attempts have been made to develop an unambiguous method to characterize SVPs, albeit with limited success. Results: Herein, we describe a robust method that characterizes and distinguishes both potentially proteinaceous and non-proteinaceous SVPs in protein formulations using Microflow imaging (MFI) in conjunction with the MVAS software (MFI View Analysis Suite), developed by Protein Simple. The method utilizes two Intensity parameters and a morphological filter that successfully distinguishes proteinaceous SVPs from non-proteinaceous SVPs and mixed aggregates. Conclusion: The MFI generated raw data of a protein sample is processed through Lumetics LINK™ software that applies an in-house developed filter to separate proteinaceous from the rest of the particulates.
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