Micro-Flow Imaging is frequently referenced in scientific publications by industry and academia. We have assembled this directory of publications for easy reference. If you have a question about a specific paper, simply contact us. Your question will be forwarded to the corresponding author who will respond to you directly.
Uncertainties in Subvisible Particulates Need to Be Understood, FDA Tells Biotech CMC Strategy Forum. Paulson B. (2011). International Pharmaceutical Quality.
Evaluation of the Effect of Syringe Surfaces on Protein Formulations. Majumdar S, Ford BM, Mar KD, Sullivan VJ, Ulrich RG, D’Souza AJM. (2011). Journal of Pharmaceutical Sciences. DOI: 10.1002/jps22515.
Subvisible Particle Counting Provides a Sensitive Method of Detecting and Quantifying Aggregation of Monoclonal Antibody Caused by Freeze-Thawing: Insights Into the Roles of Particles in the Protein Aggregation Pathway. Barnard J, Singh S, Randolph TW, Carpenter JF. (2011). Journal of Pharmaceutical Sciences. 100(2): 492-503.
Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling. Liu L, Ammar DA, Ross L, Mandava N, Kahook M, Carpenter JF. (2011). Investigative Ophthalmology & Visual Science. 52(2): 1023-1034.
Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice. van Beers MMC, Sauerborn M, Gilli F, Brinks V, Schellekens H, Jiskoot W. (2010). Pharmaceutical Research. 27(9): 1812-1824.
Stability of Protein Pharmaceuticals: An Update. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. (2010). Pharmaceutical Research. 27(4): 544-575.
High-Molecular-Weight Aggregates in Repackaged Bevacizumab. Kahook MY, Liu L, Ruzycki P, Mandava N, Carpenter JF, Petrash JM, Ammar DA. (2010). Retina. 30(6): 887-892.
Development of a Microflow Digital Imaging Assay to Characterize Protein Particulates During Storage of a High Concentration IgG1 Monoclonal Antibody Formulation. Wuchner K, Büchler J, Spycher R, Volkin D. (2010). Journal of Pharmaceutical Sciences. 99(8): 3343-3361.
Micro-Flow Imaging: Flow Microscopy Applied to Subvisible Particulate Analysis in Protein Formulations. Sharma D, King D, Oma P, Merchant C. (2010). The AAPS Journal. 12(3): 455-464.
Flow Microscopy: Dynamic Image Analysis for Particle Counting. Oma P, Sharma D, King D. (2010). Stimuli Article, USP Pharmacopeial Forum. Vol. 36 (1): 311-320.
Quantification and Characterization of Sub-Visible Proteinaceous Particles in Opalescent mAb Formulations using Micro-Flow Imaging. Sharma D, Oma P, Pollo MJ, Sukumar M. (2010). Journal of Pharmaceutical Sciences. 99(6): 2628-2642.
Meeting report on protein particles and immunogenicity of therapeutic proteins: Filling in the gaps in risk evaluation and mitigation. Carpenter JF, Cherney B, Lubinecki A, Ma S, Marszal E, Mire-Sluis A, Nikolai T, Novak J, Ragheb J, Simak J. (2010). Biologicals. 38(5): 602-611.
Best Practices for Formulation and Manufacturing of Biotech Drug Products: How to maintain product stability and prevent particulates. Singh SK, Rathore N, McAuley A, Rathore AS. (2009). BioPharm International. 22(6).
Quantitation of Protein Particles in Parenteral Solutions using Micro-Flow Imaging. Huang C, Sharma D, Oma P, Krishnamurthy R. (2009). Journal of Pharmaceutical Sciences. 98(9): 3058–3071.
Micro-Flow Imaging – Intelligent Flow Microscopy Applied to Biotechnology. Sharma D, King D, Oma P. (2009). BioProcess International. 7 (6): 62–67.
Silicone Micro-Droplets in Protein Formulations – Detection and Enumeration. Sharma D, Oma P, Krishnan S. (2009). Pharmaceutical Technology. 33(4): 74-79.
Immunogenic Potential of Aggregates Affirmed at Biotech CMC Forum. Paulson B. (2011). International Pharmaceutical Quality.
An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause H-J, Mahler H-C, Meyer BK, Narhi L, Nesta DP, Spitznagel T. (2010). Journal of Pharmaceutical Science (Perspectives). 99(8): 3302-3321.
Potential Inaccurate Quantitation and Sizing of Protein Aggregates by Size Exclusion Chromatography: Essential Need to use Orthogonal Methods to Assure the Quality of Therapeutic Protein Products. Carpenter JF, Randolph T, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G. (2010). Journal of Pharmaceutical Science (Commentary). 99(5): 2200-2208.
Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. (2009). Journal of Pharmaceutical Science (Commentary). 98(4): 1201–1205.
MFI Pharmaceutical Publication References