Pharmeuropa bio & scientific notes最新文献

{"title":"Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT testing BRP batch 2.","authors":"G Pisani,&nbsp;D Le Tallec,&nbsp;A Costanzo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The European Pharmacopoeia (Ph. Eur.) monographs <i>Human plasma for fractionation (0853)</i> and <i>Human plasma (pooled and treated for virus inactivation) (1646)</i> require that plasma pools be tested for hepatitis C virus (HCV) RNA presence by nucleic acid amplification techniques (NAT) using a positive control at 100 IU/mL. HCV RNA for NAT testing BRP batch 1 was established in 1999 to this end. Due to dwindling stocks, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to establish a replacement batch. The candidate material was produced as a lyophilised preparation of human plasma containing HCV genotype IA and calibrated against the 6th WHO International Standard for HCV RNA for NAT. Quantitative and qualitative HCV NAT assays based on real-time quantitative PCR techniques were used. Both types of assays were assessed separately. However, since no significant difference was observed between them, all results were pooled for the final potency assignment. Calculations based on Ct values were less variable than those based on end-point dilutions; they were thus used in the final combination. The combined overall mean potency was 959 IU/vial. An accelerated degradation study showed that the stability of the candidate material was satisfactory at the recommended long-term storage temperature, i.e. -20°C. The candidate BRP was established as Ph. Eur. HCV RNA for NAT testing BRP batch 2 by the Ph. Eur. Commission, with an assigned potency of 960 IU/vial. It will be available from the EDQM under catalogue number H0215000.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2023 ","pages":"15-41"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9738457","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. Human immunoglobulin for electrophoresis BRP batch 4.","authors":"M-E Behr-Gross,&nbsp;E Regourd,&nbsp;W Holtkamp","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Due to the diminished stocks of the third batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human immunoglobulin for electrophoresis, in 2020 the European Directorate for the Quality of Medicines & HealthCare (EDQM) initiated an international collaborative study for the establishment of a replacement batch. The study was run under the aegis of the Biological Standardisation Programme (BSP). Nineteen laboratories participated in the collaborative study to verify the suitability of the candidate reference preparations according to the Ph. Eur. monographs Human normal immunoglobulin for intravenous administration (0918), Human normal immunoglobulin for intramuscular administration (0338) and Human normal immunoglobulin for subcutaneous administration (2788) using the zone electrophoresis method with cellulose acetate and/or agarose as the testing medium. Capillary zone electrophoresis (CZE), a technique not yet included in monographs 0338, 0918 and 2788, was also used by some laboratories. The assignment of a value for immunoglobulin as a percentage of the total protein content could only be made for agarose electrophoresis and for CZE. The candidate preparation was found suitable for the intended purpose and was subsequently adopted by correspondence in May 2021 by the Ph. Eur. Commission as Human immunoglobulin for electrophoresis BRP batch 4 with an assigned range for immunoglobulin of 82.5 % to 87.8 % of the total protein content.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":" ","pages":"37-54"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40586959","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":"Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes.","authors":"K Fritsch,&nbsp;C Saal,&nbsp;B Spieldenner","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Weighing is a key activity in every quality control laboratory as it is one of the first steps in the preparation of samples and reagents for most analytical procedures. It is also critical because weighing errors will add up and propagate throughout the whole analysis, affecting the accuracy and precision of the reported results. A new general chapter, Balances for analytical purposes (2.1.7), has recently been published in the European Pharmacopoeia (Ph. Eur.). This new text sets out clear requirements for an instrument that is essential to every analytical procedure described within the pages of the Ph. Eur. This article explains in detail these requirements and generally reviews the other quantity-related requirements present in Ph. Eur. texts.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":" ","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39857248","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":"Validation of an ELISA method for quantification of the major Timothy grass pollen allergen Phl p 5a (BSP090).","authors":"J Zimmer,&nbsp;S Schmidt,&nbsp;A Costanzo,&nbsp;K-H Buchheit,&nbsp;S Brown,&nbsp;J Carnés,&nbsp;M Chapman,&nbsp;A Chen,&nbsp;M De Neergaard,&nbsp;S Döring,&nbsp;J Hindley,&nbsp;T Holzhauser,&nbsp;S Jorajuria,&nbsp;D Le Tallec,&nbsp;M Lombardero,&nbsp;P Iacovacci,&nbsp;G Reese,&nbsp;I Sander,&nbsp;B Smith,&nbsp;D Strecker,&nbsp;R van Ree,&nbsp;M Zebina,&nbsp;S Kaul,&nbsp;S Vieths","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Progress towards standardisation of allergen products has been made in recent years. Nevertheless, no standardised test method to quantify the allergen content of grass pollen allergen products is available at present. One aim of the BSP090 project was to validate a quantitative assay for a major Timothy grass (Phleum pratense) pollen allergen, Phl p 5. Qualification of a candidate ELISA system was performed with regard to range, robustness and cross-reactivity in preliminary studies. The assay specifically detected Phl p 5 with a quantification range from 3.9 ng/mL to 62.5 ng/mL. Suitability to quantify recombinant and natural Phl p 5 was further assessed in a collaborative study including 14 laboratories in Europe and the USA. Precision and accuracy of the assay was satisfactory with 93% of calculated Phl p 5 concentrations and 100% of total recoveries being within the ± 30% acceptance range. Similar results were obtained for spike recoveries, with exclusion of the lowest concentration spike, showing spike recoveries exceeding the acceptance range for six laboratories. Inter-assay (repeatability) and inter-laboratory (reproducibility) variability were satisfactory, in the format used in the present study. Robustness towards different statistical methods for data analysis was demonstrated. In conclusion, the assay can easily be established in routine testing and results of the preliminary testing and collaborative study support the proposal of the assessed Phl p 5-specific ELISA as a European Pharmacopoeia general method.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2022 ","pages":"55-86"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10337267","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":"An alternative and simplified approach to identification and test for minimum content of TCM herbal drugs.","authors":"D A Frommenwiler,&nbsp;C Sabatini-Samori,&nbsp;R Scherübl,&nbsp;V Wolkinger,&nbsp;A Nachtergael,&nbsp;D A Guo,&nbsp;E Reich,&nbsp;S Cañigueral,&nbsp;U Rose","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Following a decision of the European Pharmacopoeia (Ph. Eur.) Commission, the Traditional Chinese Medicines (TCM) Working Party started a pilot phase to examine the suitability of a high-performance thin-layer chromatography (HPTLC) minimum content test as an alternative to the classical assay in TCM monographs. This approach was evaluated with two TCM herbal drugs: Fritillaria thunbergii bulbs (FTB) and Corydalis rhizome (CYR). Firstly, the existing HPTLC methods were optimised for both drugs. The new methods were applied to the evaluation of multiple samples, and acceptance criteria for the identification, following Ph. Eur. chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations, were set. The HPTLC test for minimum content of markers was then developed and validated. In this test, the intensity of the marker zone in the fingerprint of the sample is compared to the corresponding zone in the reference solution, which has a concentration giving an intensity equivalent to the acceptance criterion. This test gives a pass or fail result rather than a content and can be performed visually (on the images) or by software (using peak profiles from images; PPI). Reproducibility of the HPTLC methods was evaluated in a collaborative trial including six laboratories. In summary, results for FTB from five laboratories were in agreement. The remaining laboratory did not pass the identification of the samples. For CYR, all laboratories presented the same results for identification. In the test for minimum content, one borderline sample passed in four laboratories and failed in two. All laboratories reached similar conclusions for the other seven samples. The HPTLC methods proposed offer a simplified approach to evaluating identity and minimum content of TCM drugs in a single analysis.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"1-25"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25500684","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":"Calibration of the WHO 5th IS for Blood Coagulation Factor IX, Concentrate and Ph. Eur. Human Coagulation Factor IX Concentrate Biological Reference Preparation Batch 3 and investigation of the suitability of an IS as potency standard for purified full-length recombinant FIX.","authors":"E Gray,&nbsp;J Hogwood,&nbsp;T Dougall,&nbsp;P Rigsby,&nbsp;P Matejtschuk,&nbsp;E Terao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A joint World Health Organization (WHO) - European Directorate for the Quality of Medicines & HealthCare (EDQM) study was run to calibrate the WHO 5th International Standard (IS) for Blood Coagulation Factor IX (FIX), Concentrate, and European Pharmacopoeia (Ph. Eur.) Human Coagulation Factor IX concentrate Biological Reference Preparation (BRP) Batch 3. The suitability of the 4th IS as a potency standard for purified full-length recombinant FIX (rFIX) was also investigated. Forty-nine laboratories contributed data for the calibration of 2 plasma-derived FIX candidates, relative to the 4th IS, from clotting and chromogenic assays. The intra-laboratory variability was reasonably low; the inter-laboratory variation was lower for sample B (14/148) than for sample C (14/162). Although there were no discrepancies between clotting and chromogenic assays, a significantly lower potency was obtained for sample C with clotting assays when buffer rather than FIX-deficient plasma was used as pre-diluent. A significant assay discrepancy was observed with estimates for the 4th IS for Blood Coagulation Factors FII, VII, IX, X, Plasma against the 4th IS, resulting in a clotting to chromogenic activity ratio of 1.11. The study also investigated the comparability of the plasma-derived concentrate standard with the rFIX products and considered the establishment of an IS for rFIX. The 3 rFIX products currently licensed were represented in this study. Data from 49 laboratories for 2 rFIX candidates were received, with additional results for another full-length rFIX test sample returned by 6 laboratories. The intra-laboratory variability when the rFIX samples were assayed against the 4th IS was acceptably low. Although the full-length rFIX could be assayed against the plasma-derived 4th IS and provided statistically valid results, there were large discrepancies among the clotting assays using different APTT reagents. The inter-laboratory variability of the chromogenic assays was similarly high. There were also significant clotting and chromogenic assay discrepancies. The data from the present study indicate that a recombinant standard for rFIX products will minimise assay discrepancies and improve inter-laboratory agreement. However, they also underline that the value assignment of the 1st rFIX IS needs careful consideration. The Expert Committee on Biological Standardization (ECBS) of WHO was therefore not requested to consider the establishment of an IS for rFIX. In order to ensure continued harmonised standards, sample B (14/148) was established as the WHO 5th IS for Blood Coagulation Factor IX, Concentrate, and as Ph. Eur. Human Coagulation Factor IX, concentrate BRP Batch 3 with the functional activity of 10.5 IU/ampoule.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"26-68"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25529727","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":"Proposal for a standardised method for the identification of essential oils by HPTLC.","authors":"T K T Do,&nbsp;I Trettin,&nbsp;R De Vaumas,&nbsp;S Cañigueral,&nbsp;C Valder,&nbsp;E Reich","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The European Pharmacopoeia (Ph. Eur.), includes both individual monographs on essential oils and a general monograph that covers all essential oils for pharmaceutical use, whether covered by an individual monograph or not. The individual monographs generally describe gas chromatography as a first identification test, while thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC) methods are included in the second identification series. To comply with Ph. Eur. general chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations, HPTLC parameters must be standardised. Currently, 18 of the 32 monographs on essential oils feature the same TLC/HPTLC method, but differ in terms of the other conditions described. A single, standardised chromatographic system with a system suitability test (SST) and intensity markers for all 32 essential oils covered by individual monographs would be desirable, particularly for pharmacies and other users that cannot perform gas chromatography for financial reasons. To this end, this paper describes the development of a general HPTLC method for the identification of essential oils in compliance with general chapter 2.8.25. The method proposes the use of ethyl acetate, toluene (5:95 V/V) as mobile phase, isoeugenol/isoeugenyl acetate for the SST, and a combination of one alcohol (either borneol or linalool) and one ester (either linalyl acetate or bornyl acetate) as intensity markers.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"157-166"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39602505","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 Pertussis toxin BRP batch 2 for CHO clustering assay.","authors":"M Wall,&nbsp;A Costanzo,&nbsp;D Le Tallec,&nbsp;R Isbrucker","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recently, the Chinese hamster ovary (CHO) cell-based clustering assay replaced the in vivo Histamine Sensitisation Test (HIST) in mice in European Pharmacopoeia (Ph. Eur.) general chapter 2.6.33. ‘Residual pertussis toxin’ as the recommended method to test for residual pertussis toxin in acellular pertussis vaccine intermediates. To support the standardised CHO clustering assay, availability of a reference standard is critical. Ph. Eur. pertussis toxin Biological Reference Preparation (BRP) batch 1 was first calibrated in International Units in 2008 for the HIST and subsequently also calibrated for the CHO clustering assay in 2017. However, its stocks were dwindling and needed to be replaced. In an effort to maintain adequate supply, a project (BSP141) was initiated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), under the aegis of the Biological Standardisation Programme, to establish a second pertussis toxin BRP (BRP2). Candidate material was manufactured ad hoc by an acellular pertussis vaccine manufacturer and an optimal formulation for long-term stability was defined. Exhaustive in-process and post-production controls demonstrated that the material was fit for its intended purpose and therefore a collaborative study for calibration and stability assessment of the candidate material was organised, which included 10 laboratories worldwide. As a result of the study, the candidate material was established as Ph. Eur. Pertussis toxin BRP batch 2 with a potency of 130 IU/vial for the CHO clustering assay. Unopened vials must be stored at −20°C. The BRP may be used for up to two weeks after reconstitution if appropriately handled and stored at 2–8°C.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"69-87"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38939023","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. Human albumin (molecular size) Biological Reference Preparation batches 1, 2 and 3.","authors":"N Sinitskaya,&nbsp;E Regourd,&nbsp;M Wierer,&nbsp;M-E Behr-Gross,&nbsp;V Lièvre","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>To comply with European Pharmacopoeia (Ph. Eur.) monograph Human albumin solution (0255), albumin solutions have to be tested for molecular-size distribution by size-exclusion chromatography (SEC). However, differences in interpretation of the test results continue to be observed among albumin manufacturers in Europe. A collaborative study was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM), under the aegis of the Biological Standardisation Programme (BSP), to support the revision of Ph. Eur. monograph 0255 and to establish a Biological Reference Preparation (BRP) for use in the molecular-size distribution test. In 2019, Ph. Eur. Expert Group 6B proposed to include an analytical improvement of the SEC procedure in the monograph, which was then submitted for public enquiry. This publication describes the evaluation of three candidate BRPs to serve as a tool for both the system suitability test (SST) and albumin monomer and dimer peak identification according to the proposed revised methodology. Three Official Medicines Control Laboratories (OMCLs) involved in the official batch release of human albumin solution took part in the study. Based on the study results, the candidate BRPs were found suitable for purpose and were adopted by the Ph. Eur. Commission as Ph. Eur. Human albumin (molecular size) BRP batches 1, 2 and 3 concomitantly with the revised monograph Human albumin solution (0255) in November 2020.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"184-198"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39606976","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":"Calibration of the Ph. Eur. human coagulation Factor VIII Concentrate BRP batch 6.","authors":"S Raut,&nbsp;D Le Tallec,&nbsp;A Costanzo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human coagulation Factor VIII (FVIII) Concentrate is used as working standard for potency determination of human coagulation FVIII preparations by chromogenic assay. BRP batch 5 was established in 2015 and its stocks were running low. Therefore, the European Directorate for the Quality of Medicines & HealthCare (EDQM) initiated a project (BSP156) for the calibration of a replacement batch. The potency of BRP batch 6 was assigned during an international collaborative study involving 16 laboratories worldwide, with reference to the WHO 8th International Standard (IS) and BRP batch 5. Participants were instructed to perform 3 independent FVIII potency assays following their own routine validated methods for the chromogenic assay, which is the assay prescribed by the Ph. Eur. As an outcome of the study, Ph. Eur. human coagulation FVIII Concentrate BRP batch 6 was assigned a consensus potency of 9.9 IU/ampoule for the chromogenic assay. The Ph. Eur. BRP batch 6 is a freeze-dried, plasma-derived concentrate. Based on accelerated degradation studies, the stability of the material is suitable for a reference preparation. The Ph. Eur. BRP batch 6 was adopted at the 167th session of the Ph. Eur. Commission in June 2020 and is available from the EDQM under product code H0920000.</p>","PeriodicalId":39192,"journal":{"name":"Pharmeuropa bio & scientific notes","volume":"2021 ","pages":"88-100"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38969968","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}