Particle detection and characterization for biopharmaceutical applications: current principles of established and alternative techniques
J Gross-Rother, M Blech, E Preis, U Bakowsky… - Pharmaceutics, 2020 - mdpi.com
Detection and characterization of particles in the visible and subvisible size range is critical
in many fields of industrial research. Commercial particle analysis systems have proliferated …
in many fields of industrial research. Commercial particle analysis systems have proliferated …
[HTML][HTML] Particles in biopharmaceutical formulations, part 2: an update on analytical techniques and applications for therapeutic proteins, viruses, vaccines and cells
A Roesch, S Zölls, D Stadler, C Helbig… - Journal of …, 2022 - Elsevier
Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …
With new product classes emerging it is crucial to discriminate particulate active …
Particles in therapeutic protein formulations, Part 1: overview of analytical methods
S Zölls, R Tantipolphan, M Wiggenhorn… - Journal of …, 2012 - Elsevier
The presence of particles is a major issue during therapeutic protein formulation
development. Both proteinaceous and nonproteinaceous particles need to be analyzed not …
development. Both proteinaceous and nonproteinaceous particles need to be analyzed not …
Protein particulate detection issues in biotherapeutics development—current status
TK Das - Aaps Pharmscitech, 2012 - Springer
Formation of aggregates and particulates in biopharmaceutical formulation continues to be
one of the major quality concerns in biotherapeutics development. The presence of large …
one of the major quality concerns in biotherapeutics development. The presence of large …
Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis
V Corvari, LO Narhi, TM Spitznagel, N Afonina, S Cao… - Biologicals, 2015 - Elsevier
Measurement and characterization of subvisible particles (including proteinaceous and non-
proteinaceous particulate matter) is an important aspect of the pharmaceutical development …
proteinaceous particulate matter) is an important aspect of the pharmaceutical development …
The application of STEP-technology® for particle and protein dispersion detection studies in biopharmaceutical research
J Gross-Rother, N Herrmann, M Blech… - International journal of …, 2018 - Elsevier
Particle detection and analysis techniques are essential in biopharmaceutical industries to
evaluate the quality of various parenteral formulations regarding product safety, product …
evaluate the quality of various parenteral formulations regarding product safety, product …
Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: part 1, considerations and strategy
LO Narhi, V Corvari, DC Ripple, N Afonina… - Journal of …, 2015 - Elsevier
Measurement and characterization of subvisible particles (defined here as those ranging in
size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an …
size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an …
A critical review of analytical methods for subvisible and visible particles
LO Narhi, Y Jiang, S Cao, K Benedek… - Current …, 2009 - ingentaconnect.com
The subvisible and visible particles present in a solution are often classified based on size,
and are quantified by the actual number of particles present rather than by weight or molar …
and are quantified by the actual number of particles present rather than by weight or molar …
Issues and challenges of subvisible and submicron particulate analysis in protein solutions
TM Scherer, S Leung, L Owyang, SJ Shire - The AAPS journal, 2012 - Springer
The analysis of particulates has been a longstanding challenge in biopharmaceutical drug
product development and quality control because the active constituents themselves may …
product development and quality control because the active constituents themselves may …
Nanoparticle tracking analysis of particle size and concentration detection in suspensions of polymer and protein samples: Influence of experimental and data …
J Gross, S Sayle, AR Karow, U Bakowsky… - European Journal of …, 2016 - Elsevier
Abstract Nanoparticle Tracking Analysis (NTA) is an emerging technique for detecting
simultaneously sub-micron particle size distributions and particle concentrations of a …
simultaneously sub-micron particle size distributions and particle concentrations of a …