Pharmeuropa bio & scientific notes最新文献

{"title":"Ph. Eur. testing for histamine and depressor substances using guinea-pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur.","authors":"M Bratos, O Kolaj-Robin, M Antoni, E Charton","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>For more than 50 years, <i>in vivo</i> assays have been used for testing pharmaceutical product safety due to their assumed ability to broadly detect potential unidentified contaminants. As part of these in vivo tests, the animal tests for depressor substances and histamine have been described in the European Pharmacopoeia since its first edition in 1977. Both tests measure the effect of histamine and histamine-like substances, using guinea-pigs and cats respectively. In 2024, the <i>Histamine (2.6.10)</i> general chapter is referenced in the Production section of four monographs and 10 monographs have variations of a sentence on designing the manufacturing process to eliminate or minimise substances lowering blood pressure in this same section, without referencing the chapter. The <i>Depressor substances (2.6.11)</i> chapter is referenced only in the <i>Histamine (2.6.10)</i> chapter as a next step if the histamine test is invalid. A historical search was performed and it has shown that the tests for histamine and for depressor substances were introduced by different groups of experts in an inconsistent way at different times, and for different reasons, leading to non-harmonised approaches across monographs. The control of histamine and other depressor substances has been the subject of numerous debates where their use was questioned. During these discussions, reports on positive cases or batches failing the test for histamine or depressor substances were anecdotal. In addition, in vivo tests can be considered non-specific, very variable, time-consuming, costly and ethically doubtful. More importantly, the majority of in vivo methods originate from a time when good manufacturing practice was not widely used and formal method validation requirements were not yet established. In view of the above, the removal of all references to animal tests for histamine or depressor substances from all texts still referring to them is proposed. Since the sentences in the Production section referring to the control of \"substances lowering blood pressure\", \"vasoactive substances\" or \"hypotensive substances\" appeared as remainders of the animal test without further guarantee of safety, it will also be proposed to remove all these sentences from the concerned monographs. Ultimately, the suppression of general chapters <i>2.6.10</i> and <i>2.6.11</i> from the Ph. Eur. is envisaged. Independently from the above, it is also envisaged to elaborate a new general chapter <i>Histamine in active substances (2.5.47)</i> to include physicochemical or immunochemical methods enabling the detection of histamine. This new text would aim at supporting manufacturers in their histamine control strategy following the inclusion of precaution statements in the general monograph on <i>Products of fermentation (1468)</i>; these statements had been added in Ph. Eur. Supplements 9.6 and 10.4, following adverse events related to a GMP issue with gentamicin sulfate. This strategy has ","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"12-26"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishment of hepatitis A virus coating reagent batch 2 for <i>in vitro</i> potency assay of hepatitis A vaccines by ELISA.","authors":"S Morgeaux, I Manniam, D Le Tallec, P Chagnaud, A Costanzo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The European Pharmacopoeia (Ph. Eur.) prescribes that hepatitis A vaccine (HAV) batches be tested for their potency before being released onto the European market. An enzyme-linked immunosorbent assay (ELISA) method for determination of antigen content of HAV was validated through an international collaborative study in 2012. This method requires specific coating and detection antibodies, i.e. coating reagent and detection antibodies Biological Reference Reagents (BRRs). The current batch of hepatitis A virus coating reagent (batch 1) was established in 2012. Stocks of this BRR were running low and a replacement batch was needed. Therefore, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify a replacement batch. Candidate coating reagent batch 2 was prepared from the same starting material as batch 1 and compared to the previous batch during the collaborative study. Results confirmed that candidate coating reagent batch 2 is suitable to be used for the intended purpose. The study demonstrated that batch 2 is comparable to batch 1 and that it can be used at the same working concentration, i.e. 1:500. The candidate material was adopted as Ph. Eur. Hepatitis A virus Coating Reagent for ELISA BRR batch 2 by the Ph. Eur. Commission at its 177th session in November 2023. It will be available from the EDQM under catalogue number Y0001624 once batch 1 is exhausted.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"240-250"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142773289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative study for the establishment of Human immunoglobulin (molecular size) BRP replacement batches 4, 5 and 6.","authors":"S Jouette, E Regourd","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Human immunoglobulin products are used for the treatment of a number of diseases, such as primary or secondary immunodeficiencies and autoimmune conditions due to the complete absence of antibodies or the production of defective immunoglobulins. Quality control of human immunoglobulin products is essential to ensure therapeutic functionality and safety. This includes testing for Fc function and anticomplementary activity (ACA), as well as verification of appropriate molecular size distribution using size-exclusion chromatography as prescribed in the European Pharmacopoeia (Ph. Eur.) monographs 0338, 0918, 2788 and 1928. To this end, specific biological reference preparations (BRPs) must be used. Stocks of the Ph. Eur. Human immunoglobulin (molecular size) BRP were running low and therefore a collaborative study was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM), under the aegis of the Biological Standardisation Programme, to calibrate replacement batches. Eighteen laboratories, including manufacturers and Official Medicines Control Laboratories, took part in the study. Three batches of candidate BRPs were assessed and compared to Ph. Eur. Human immunoglobulin (molecular size) BRP 3 to ensure continuity. Based on the study results, the candidate BRPs were adopted by the Ph. Eur. Commission as Ph. Eur. Human immunoglobulin (molecular size) BRP batch 4, 5 and 6.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"90-105"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Joint WHO/EDQM Collaborative study for the establishment of WHO 3^rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7.","authors":"B Fox, E Regourd, P Rigsby, C Longstaff, E Terao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>An international collaborative study was jointly organised by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO 3^rd International Standard (IS) for Prekallikrein activator (PKA) and European Pharmacopoeia (Ph. Eur.) PKA in albumin Biological Reference Preparation (BRP) batch 7. Twenty-six laboratories took part in the study to calibrate these replacement batches, as well as an additional reserve batch for the WHO IS, against the current WHO 2^nd IS for PKA (02/168). Ph. Eur. PKA in albumin BRP batch 6 was also included to evaluate the continuity of the consecutive batches of BRP. The centrally calculated overall Huber's means based on the results from laboratories with at least two valid assays were 29.6 and 29.6 IU/ampoule for the candidate WHO 3^rd IS (Sample A) and reserve batch (Sample B), and were 38.4 and 37.0 IU/vial for the current BRP batch 6 (Sample C) and the candidate BRP batch 7 (Sample D). The intra-laboratory variation expressed as coefficient of variation (CV) ranged between 1.4 and 16.6 %. The inter-laboratory variation expressed as CV based on Huber's means ranged between 4.4 and 5.4 %. The Huber's mean activity of Sample D against Sample C was 36.6 IU/vial with a CV of 1.7 %. These results confirm the good continuity of the consecutive batches of BRP. Based on the results of this study, it is recommended to establish Sample A as the WHO 3^rd IS for PKA with an assigned potency of 30 IU/ampoule and Sample D as the Ph. Eur. PKA in albumin BRP batch 7 with an assigned potency of 37 IU/vial. Sample B is intended to be kept as a future reserve replacement WHO IS.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"106-126"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141621155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishment of Erythropoietin for physicochemical tests CRS batch 2.","authors":"B Cowper, D Le Tallec, A Costanzo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Here we report the outcome of a collaborative study aimed at demonstrating the suitability of the candidate Chemical Reference Substance (CRS) as a replacement reference (batch 2) for the physicochemical methods in European Pharmacopoeia monograph <i>1316 Erythropoietin concentrated solution</i>. Results from the study demonstrated that for the physicochemical methods described in the monograph - capillary zone electrophoresis, polyacrylamide gel electrophoresis and immunoblotting, peptide mapping and glycan mapping - the candidate CRS is essentially identical to CRS batch 1 and is suitable to be established as Erythropoietin for physicochemical tests CRS batch 2. CRS batch 2 is a freeze-dried preparation presented in vials. It was adopted at the 177th session of the European Pharmacopoeia Commission in November 2023 and is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM) under product code Y0001725.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"251-274"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2.","authors":"P Stickings, R Tierney, J Hockley, P Rigsby, E Terao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This publication describes the outcome of a project to develop a replacement European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin (TIg) as well as for the World Health Organization (WHO) International Standard (IS) for Tetanus Immunoglobulin, Human. Bulk TIg was kindly provided by a European manufacturer and was used to prepare the candidate standard. The candidate standard was freeze-dried and calibrated in an international collaborative study jointly co-ordinated by the Medicines & Healthcare products Regulatory Agency (MHRA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe). The results of this study show that there was good agreement between laboratories for the potency estimates obtained for the candidate standard relative to the current WHO IS/Ph. Eur. BRP. The study also demonstrated that the candidate standard is suitable for use in Ph. Eur. assays for potency testing of TIg products and there was good agreement in the potency estimates obtained using the different assay methods included in the study. Accelerated degradation studies performed at the MHRA over a period of 4 years suggest that the freeze-dried candidate standard will be very stable. The candidate standard was established as Ph. Eur. BRP for Human tetanus immunoglobulin, batch 2 with an assigned potency of 45 IU/ampoule. The same preparation was also adopted by the WHO Expert Committee on Biological Standardization (ECBS) to serve as the WHO 2^nd IS for Tetanus Immunoglobulin, Human (13/240).</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative study for the establishment of Golimumab Biological Reference Preparation Batch 1.","authors":"M Wadhwa, P Rigsby, M-E Behr-Gross","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A candidate preparation of the fully human anti-tumour necrosis factor (TNF) monoclonal antibody golimumab was formulated and lyophilised at the Medicines and Healthcare products Regulatory Agency (MHRA) prior to evaluation in a collaborative study for its suitability to serve as a World Health Organization (WHO) International Standard (IS)/European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for the potency assay of golimumab. Fifteen laboratories tested the preparations using different cell-based TNF-α neutralisation assays. Among them, seven laboratories also performed binding assays and one additional laboratory assessed antibody-dependent cellular cytotoxicity. The results of this study and the stability data generated by the MHRA indicated that the candidate preparation, coded 22/116, was suitable to serve as an IS for golimumab based on the data obtained for biological activity. This candidate standard was established in 2024 as the first IS for golimumab with an assigned potency of 500 IU per ampoule for TNF neutralising activity. In the same study, the suitability of this preparation of golimumab to serve as the Ph. Eur. BRP for the golimumab potency assay, as described in the Ph. Eur. monographs on <i>Golimumab injection (3187)</i> and <i>Golimumab concentrated solution (3103)</i>, was also evaluated. The corresponding analysis, based on the measurement of the inhibitory action of golimumab on the cytotoxic activity of TNF-α, was performed using data from a subset of six laboratories - whose experts were members of the P4 Biologicals Working Party (responsible for the elaboration of the golimumab monographs) - using the TNF-α-sensitive mouse fibrosarcoma cell lines WEHI-164 or WEHI-164 clone 13 variant (WEHI-13VAR, ATCC CRL-2148) in example bioassay procedure(s) described in Ph. Eur. monographs <i>3103</i> and <i>3187</i>, or running the same cell-based assays using in-house procedures. The results obtained were compared with those obtained from different cell-based neutralisation assays that were used by other laboratories in the context of establishing the 1st WHO IS for golimumab. Based on the analyses, preparation 22/116 was adopted by the Ph. Eur. Commission in June 2024 as <i>Golimumab BRP batch 1</i> with an assigned potency of 500 IU of TNF neutralising activity per ampoule.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2024 ","pages":"234-239"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142773133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2.","authors":"P Stickings, R Tierney, J Hockley, P Rigsby, E Terao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This publication describes the outcome of a project to develop a replacement European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin (TIg) as well as for the World Health Organization (WHO) International Standard (IS) for Tetanus Immunoglobulin, Human. Bulk TIg was kindly provided by a European manufacturer and was used to prepare the candidate standard. The candidate standard was freeze-dried and calibrated in an international collaborative study jointly co-ordinated by the Medicines & Healthcare products Regulatory Agency (MHRA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe). The results of this study show that there was good agreement between laboratories for the potency estimates obtained for the candidate standard relative to the current WHO IS/Ph. Eur. BRP. The study also demonstrated that the candidate standard is suitable for use in Ph. Eur. assays for potency testing of TIg products and there was good agreement in the potency estimates obtained using the different assay methods included in the study. Accelerated degradation studies performed at the MHRA over a period of 4 years suggest that the freeze-dried candidate standard will be very stable. The candidate standard was established as Ph. Eur. BRP for Human tetanus immunoglobulin, batch 2 with an assigned potency of 45 IU/ampoule. The same preparation was also adopted by the WHO Expert Committee on Biological Standardization (ECBS) to serve as the WHO 2nd IS for Tetanus Immunoglobulin, Human (13/240).</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2023 ","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative study for the establishment of replacement batches of Ph. Eur. Heparin Low-Molecular-Mass for Calibration CRS.","authors":"S Caruncho Garcia-Moreno, B Mulloy, I Rodrigo-Castro, W Denault, D Le Tallec, E Terao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>An international collaborative study was run within the framework of the Biological Standardisation Programme (BSP) of the Council of Europe and the Commission of the European Union to establish replacement batches for European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass (LMM) for calibration Chemical Reference Substance batch 3 (CRS3) used for the characterisation of LMM heparins by high performance size-exclusion chromatography. Two candidate batches (A, cCRS4 and B, cCRS5) were filled using the same material as the existing official calibrants, adopted with either an assigned number-average molecular mass (Mna) or a broad standard table (BST). Fifteen laboratories evaluated the suitability of these candidate batches for use as calibrants with the pharmacopoeial dual refractive index/ultraviolet (RI/UV) detector calibration method, as well as with a modified mobile phase and the BST calibration method. Seven preparations of LMM heparin were tested. The results confirmed that the proposed batches are suitable for use with the same characteristic Mna as CRS3 and with the BST established for the World Health Organization (WHO) 2^nd International Standard (IS). The BST calibration method gave comparable results to the RI/UV method, while showing better reproducibility, being easier to perform and requiring no calibrant with UV absorbance. The modified mobile phase had no impact on the calculated values while improving separation between the calibrant and salt peaks. The two candidate batches were adopted as Ph. Eur. Heparin LMM for calibration CRS batches 4 and 5, respectively, with the assigned Mna value of 3800 and a BST. In anticipation of the depletion of the calibrant required for use with the RI/UV method, and taking into account the unlikely procurement of a new lot of suitable starting material, it was recommended to include the BST method in Ph. Eur. monograph <i>0828, Heparins, low-molecular-mass</i>. In order to improve peak separation, it was also recommended to include the use of ammonium acetate solution as mobile phase in the monograph, both for the Ph. Eur. RI/UV and the proposed BST calibration methods. Further to this study, Ph. Eur. monograph <i>0828</i> was revised to replace the RI/UV method by the BST method. This contributed to the harmonisation of methods across regions, thereby facilitating a concerted global action for the development and establishment of the next batches of calibrants for the quality control of LMM heparins.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2023 ","pages":"81-111"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138463209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112).","authors":"S Raut,&nbsp;A Daas,&nbsp;P Rigsby,&nbsp;A Costanzo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Chromogenic assay discrepancies were reported at General European Official Medicines Control Laboratories Network (GEON) meetings by laboratories testing FVIII-products. The objectives of the present investigation were to carry out a controlled collaborative study to examine these reports and to delineate the reasons for these discrepancies by assessing affected and unaffected FVIII products. The laboratories followed a strict study protocol, which included assessing their own individual observed factor X (FX) activation times, i.e. the time to reach 50% of maximal FX activation (T_1/2), for each chromogenic kit. This measurement was used, in parallel with the kit manufacturers' prescribed FX activation times, to assess the performance of the chromogenic potency assays on FVIII test products. This study confirmed a significant discrepancy between Coatest® and Coamatic® kits and between Siemens and Coamatic® kits when the kit manufacturers' prescribed T_1/2 incubation times were followed. Coamatic® kits tended to produce higher potencies than the Coatest® or Siemens kits. Furthermore, FX activation assays revealed marked differences between individual laboratories for all three chromogenic kits in the observed T_1/2 incubation times, which also did not correspond to the prescribed T_1/2 incubation times. The resulting differences in potency between kits, in some cases, were significantly reduced when using the actual observed T_1/2 incubation times instead of the prescribed T_1/2 incubation times. The study showed that FVIII potency discrepancies can occur between chromogenic kits. To compensate for this, laboratories should ideally perform FX activation curves for each new chromogenic kit in order to determine the correct observed T_1/2 incubation times, which can then be used to determine FVIII potencies in therapeutic concentrates.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2023 ","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9569743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}