Performance qualification for reproducible Surface Plasmon Resonance analysis

Steinicke, Franziska; Oltmann-Norden, Imke; Wätzig, Hermann

doi:10.1016/j.ab.2017.12.027

Cited by 4 publications

(5 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Some reasons for this lack in precision can easily be avoided. The established quality assurance procedures known from analytical quality control, such as well‐defined and detailed protocols, analytical instrument qualification (AIQ) and proper standard operation procedures (SOPs) are essential for successful bioanalyses as well . A particular attention is required for sample preparation steps, since artifacts such as aggregates have often been described as error source.…”

Section: Introduction and Objectivementioning

confidence: 99%

Experimental design and measurement uncertainty in ligand binding studies by affinity capillary electrophoresis

et al. 2019

Self Cite

View full text Add to dashboard Cite

Experimental design and measurement uncertainty in ligand binding studies by affinity capillary electrophoresisIn all life sciences ligand binding assays (LBAs) play a crucial role. Unfortunately these are very error prone. One part of this uncertainty results from the unavoidable random measurement uncertainty, another part can be attributed to the experimental design. To investigate the latter, uncertainty propagation was evaluated as a function of the given experimental design. A design space including the normalized maximum response range (nMRR), the data point position (DPP), the data point range (DPR) and the number of data points (NoDP) was defined. Based on ten measured ms ACE source data sets 20 specific parameter sets were selected by Design of Experiments. Monte Carlo simulations using 100 000 repeats for every parameter set were employed. The resulting measurement uncertainty propagation factors (measurement uncertainty multiplier: MUM) were used to describe the whole design space by polynomial regression. The resulting 5-dimensional response surface was investigated to evaluate the design parameter's influence and to find the minimal uncertainty propagation. It could be shown, that the nMRR is of highest importance, followed by DPP and DPR. Interestingly, the NoDP is less relevant. However, the interactions of the four parameters need to be carefully considered during design optimization. Using at least five data points which cover over 40% of the upper part of the binding hyperbola (DPP Ͼ 0.57) the MUM will be minimized (MUM approximately 1.5) when the nMRR is appropriate. It is possible to reduce the measurement uncertainty propagation more than one order of magnitude.Abbreviations: , electrophoretic mobility; c KD , theoretical mobility at the ligand concentration equals the K D -value; c , mobility of the complex; f , mobility of the free analyte; AIQ, analytical instrument qualification; aMRR, absolute maximum response range; BGE, background electrolyte; BSA, bovine serum albumin; c, concentration; c 0 , in absence of ligand; c Ý , in presence of a theoretically infinite ligand concentration; CD, sulfobutyl ether betacyclodextrine derivates; CI mean , confidence interval of the mean; const, constant parameter; conti, continuous parameters; DPP, data point position; DPR, data point range; DS, design space; E-systems, example analyte/ligand systems; G, Gradient; HC, hydrocorti-sone; HPAC, high performance affinity chromatography; HSA, human serum albumin; K A , association constant; K D , dissociation constant; LBA, ligand binding assay; LBAs, ligand binding assays; MRR, maximum response range; ms ACE, mobility shift affinity capillary electrophoresis; MUM, measurement uncertainty multiplier; MUP, measurement uncertainty propagation; nDS, normalized design space; nMRR, normalized maximum response range; NoDP, number of data points; PMS, parameter sets; PPS, pentosan polysulfate; R", complexed fraction; RSD, relative standard deviation; SOP, standard operating procedure; SPR, surface plasmon resona...

show abstract

Section: Introduction and Objectivementioning

confidence: 99%

Experimental design and measurement uncertainty in ligand binding studies by affinity capillary electrophoresis

et al. 2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…To validate the physical association of TA with PDI, we used surface plasmon resonance (SPR) to examine the binding of TA and recombinant human PDI in vitro. The real‐time and high sensitive approach 31 allowed us to detect that TA bound PDI molecules with a binding time of 180 seconds and a dissociation time of 7200 seconds (Figure 1E). The binding constant K a was 5942 (mol/L)/s and k D was below 1.68 × 10 −9 mol/L.…”

Section: Resultsmentioning

confidence: 99%

Molecular docking‐assisted screening reveals tannic acid as a natural protein disulphide isomerase inhibitor with antiplatelet and antithrombotic activities

Ren

You

et al. 2020

J Cellular Molecular Medi

View full text Add to dashboard Cite

show abstract

“…The analytical instrument qualification (AIQ) is the fundament for quality management in laboratories. It consists of four activities which are design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [556,561]. DQ concerns the responsibility of the manufacturer for a robust design and the availability of specifications and requirements, whereas users should consider their need for support installation and services [556].…”

Section: Instrument Qualificationmentioning

confidence: 99%

“…The next step is the IQ, which involves the setup of the instrument in its environment and must be done for new and pre-owned devices. The OQ consists of the testing of the basic instrument functions after the first implementation or significant modification to verify the declarations specified by the manufacturer and to test the operating limits [561]. The final step involves the PQ.…”

Section: Instrument Qualificationmentioning

confidence: 99%

“…This examines whether the instrument performs according to the user's specifications [556]. According to Pögel et al., a PQ should be done at least once a month and also in combination with system suitability tests (SSTs) and QC checks (QCC) [561]. An SST is a procedure that tests whether the method and instrument combined perform according to the requirements set based on knowledge of critical method parameters and handling, on the occasion of the actual analysis.…”

Section: Validationmentioning

confidence: 99%

See 1 more Smart Citation

Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

et al. 2023

Self Cite

View full text Add to dashboard Cite

This review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out which fundamentals are still valid and at the same time showing the enormous achievements in the last 25 years. The structures of both reviews are widely similar, in order to facilitate their simultaneous use. Focusing on pharmaceutical and biological applications, the successful use of CE is now demonstrated by more than 600 carefully selected references. Many of those are recent reviews; therefore, a significant overview about the field is provided. There are extra sections about sample pretreatment related to CE and microchip CE, and a completely revised section about method development for protein analytes and biomolecules in general. The general strategies for method development are summed up with regard to selectivity, efficiency, precision, analysis time, limit of detection, sample pretreatment requirements, and validation.

show abstract

Performance qualification for reproducible Surface Plasmon Resonance analysis

Cited by 4 publications

References 29 publications

Experimental design and measurement uncertainty in ligand binding studies by affinity capillary electrophoresis

Experimental design and measurement uncertainty in ligand binding studies by affinity capillary electrophoresis

Molecular docking‐assisted screening reveals tannic acid as a natural protein disulphide isomerase inhibitor with antiplatelet and antithrombotic activities

Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

Contact Info

Product

Resources

About