The Experts below are selected from a list of 270 Experts worldwide ranked by ideXlab platform

Atanas V. Koulov - One of the best experts on this subject based on the ideXlab platform.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical Research, 2016
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    PurposeThe current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.MethodsThe performance of individual techniques was evaluated using a commercial biologic drug product in a prefilled syringe container. In control experiments, latex spheres were used as standards and instrument calibration suspensions.ResultsThe results reported in this manuscript clearly demonstrated that the Particle Measurement techniques operating in the submicrometer range have much lower precision than the micrometer size-range methods. It was established that the main factor governing the relatively poor precision of submicrometer methods in general and inherently, is their low sampling volume and the corresponding large extrapolation factors for calculating final results.ConclusionsThe variety of new methods for submicrometer Particle analysis may in the future support product characterization; however, the performance of the existing methods does not yet allow for their use in routine practice and quality control.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical research, 2015
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    Purpose The current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.

Anacelia Ríos Quiroz - One of the best experts on this subject based on the ideXlab platform.

Jon Andersson - One of the best experts on this subject based on the ideXlab platform.

  • Particle Measurement programme (PMP) light-duty inter-laboratory exercise: comparison of different Particle number Measurement systems
    Measurement Science and Technology, 2008
    Co-Authors: Barouch Giechaskiel, Panagiota Dilara, Emma Sandbach, Jon Andersson
    Abstract:

    The Particle Measurement programme (PMP) used a Particle Measurement system (reference system (RS)) to quantify the Particle number emissions of several vehicles. The RS was circulated around several laboratories to represent an internal standard. During the exercise dilution factors, losses and volatile removal efficiencies of the RS were regularly checked. In parallel with the RS, some labs employed their own Particle Measurement systems (lab systems (LS)) to determine the emissions of the same test vehicles. Comparisons between results from the RS and the LS showed that several different instruments were capable of measuring Particle number emissions to within ±15% across an emission range of four orders of magnitude. Real-time emission patterns also correlated well in most cases. However, larger differences were observed when dilution factors and losses were not accurately determined and subjected to correction. Equivalence between Measurement systems can be achieved once calibration and validation procedures are standardized for both manufacturers and users.

  • Particle Measurement programme pmp light duty inter laboratory exercise repeatability and reproducibility of the Particle number method
    Aerosol Science and Technology, 2008
    Co-Authors: Barouch Giechaskiel, Panagiota Dilara, Jon Andersson
    Abstract:

    A Euro 4 Light-Duty Diesel vehicle equipped with a diesel particulate filter (DPF) was circulated to 9 labs where repetitions of the current regulatory New European Drive Cycle (NEDC) were conducte...

Hanns-christian Mahler - One of the best experts on this subject based on the ideXlab platform.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical Research, 2016
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    PurposeThe current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.MethodsThe performance of individual techniques was evaluated using a commercial biologic drug product in a prefilled syringe container. In control experiments, latex spheres were used as standards and instrument calibration suspensions.ResultsThe results reported in this manuscript clearly demonstrated that the Particle Measurement techniques operating in the submicrometer range have much lower precision than the micrometer size-range methods. It was established that the main factor governing the relatively poor precision of submicrometer methods in general and inherently, is their low sampling volume and the corresponding large extrapolation factors for calculating final results.ConclusionsThe variety of new methods for submicrometer Particle analysis may in the future support product characterization; however, the performance of the existing methods does not yet allow for their use in routine practice and quality control.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical research, 2015
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    Purpose The current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.

Joerg Huwyler - One of the best experts on this subject based on the ideXlab platform.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical Research, 2016
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    PurposeThe current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.MethodsThe performance of individual techniques was evaluated using a commercial biologic drug product in a prefilled syringe container. In control experiments, latex spheres were used as standards and instrument calibration suspensions.ResultsThe results reported in this manuscript clearly demonstrated that the Particle Measurement techniques operating in the submicrometer range have much lower precision than the micrometer size-range methods. It was established that the main factor governing the relatively poor precision of submicrometer methods in general and inherently, is their low sampling volume and the corresponding large extrapolation factors for calculating final results.ConclusionsThe variety of new methods for submicrometer Particle analysis may in the future support product characterization; however, the performance of the existing methods does not yet allow for their use in routine practice and quality control.

  • Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe
    Pharmaceutical research, 2015
    Co-Authors: Anacelia Ríos Quiroz, Jens Lamerz, Thierry Cunha, Adeline Boillon, Christof Finkler, Joerg Huwyler, Hanns-christian Mahler, Michael Adler, Roland Schmidt, Atanas V. Koulov
    Abstract:

    Purpose The current study was performed to assess the precision of the principal subvisible Particle Measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.