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Pharmeuropa Bio & Scientific Notes

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https://www.readbyqxmd.com/read/28279253/collaborative-study-for-the-establishment-of-the-ph-eur-hepatitis-e-virus-rna-for-nat-testing-biological-reference-preparation-batch-1
#1
S A Baylis, E Terao, J Blümel, K-M O Hanschmann
A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU)...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/28279252/calibration-of-the-ph-eur-human-coagulation-factor-viii-concentrate-brp-batch-5
#2
S Raut, A Costanzo, A Daas, K H Buchheit
The European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for Factor VIII Concentrate batch 5 was established through a collaborative study involving 14 laboratories organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to be used as working standard for potency determination of human coagulation Factor VIII (FVIII) preparations. The potency of the BRP batch 5 was assigned with reference to the WHO 8(th) International Standard (IS) for FVIII Concentrate and the BRP batch 4...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/28279256/in-search-of-acceptable-alternatives-to-the-murine-histamine-sensitisation-test-hist-what-is-possible-and-practical
#3
L Wagner, R Isbrucker, C Locht, J Arciniega, A Costanzo, R McFarland, H Oh, M Hoonakker, J Descamps, S R Andersen, R K Gupta, K Markey, J M Chapsal, K Lidster, W Casey, D Allen
The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test (HIST): What is Possible and Practical?' was held on 4 and 5 March 2015 in London, United Kingdom. Participants discussed the results of the data generated from an international collaborative study (BSP114 Phase 2) sponsored by the European Directorate for the Quality of Medicines & Health Care (EDQM) to determine if a modified Chinese hamster ovary (CHO) cell-based clustering assay is a suitable alternative to replace HIST...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/28279255/european-pharmacopoeia-biological-reference-preparation-for-poliomyelitis-vaccine-inactivated-collaborative-study-for-the-establishment-of-batch-no-3
#4
J Martin, A Daas, C Milne
Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an in vitro D antigen quantification assay for potency determination on the final lot as outlined in the European Pharmacopoeia (Ph. Eur.) monograph 0214. Performance of this assay requires a reference preparation calibrated in International Units (IU). A Ph. Eur. biological reference preparation (BRP) for poliomyelitis vaccine (inactivated) calibrated in IU has been established for this purpose...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/28279254/elaborating-european-pharmacopoeia-monographs-for-biotherapeutic-proteins-using-substances-from-a-single-source
#5
M Buda, S Wicks, E Charton
For more than twenty years, the European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic proteins have been elaborated using the multisource approach (Procedure 1), which has led to robust quality standards for many of the first-generation biotherapeutics. In 2008, the Ph. Eur. opened up the way towards an alternative mechanism for the elaboration of monographs (Procedure 4-BIO pilot phase), which is applied to substances still under patent protection, based on a close collaboration with the Innovator company, to ensure a harmonised global standard and strengthen the quality of the upcoming products...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27593533/interpretation-of-size-exclusion-chromatography-for-the-determination-of-molecular-size-distribution-of-human-immunoglobulins
#6
S Christians, S Schluender, N D van Treel, M-E Behr-Gross
Molecular-size distribution by size-exclusion chromatography (SEC) [1] is used for the quantification of unwanted aggregated forms in therapeutic polyclonal antibodies, referred to as human immunoglobulins (Ig) in the European Pharmacopoeia. Considering not only the requirements of the monographs for human normal Ig (0338, 0918 and 2788) [2-4], but also the general chapter on chromatographic techniques (2.2.46) [5], several chromatographic column types are allowed for performing this test. Although the EDQM knowledge database gives only 2 examples of suitable columns as a guide for the user, these monographs permit the use of columns with different lengths and diameters, and do not prescribe either particle size or pore size, which are considered key characteristics of SEC columns...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27507705/collaborative-study-for-the-calibration-of-replacement-batches-for-the-heparin-low-molecular-mass-for-assay-biological-reference-preparation
#7
E Terao, A Daas
The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). An international collaborative study coded BSP133 was launched in the framework of the Biological Standardisation Programme (BSP) run under the aegis of the Council of Europe and the European Commission to calibrate replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay Biological Reference Preparation (BRP) batch 8...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27507619/collaborative-study-for-the-validation-of-an-improved-hplc-assay-for-recombinant-ifn-alfa-2
#8
K H Jönsson, A Daas, K H Buchheit, E Terao
The current European Pharmacopoeia (Ph. Eur.) texts for Interferon (IFN)-alfa-2 include a nonspecific photometric protein assay using albumin as calibrator and a highly variable cell-based assay for the potency determination of the protective effects. A request was expressed by the Official Medicines Control Laboratories (OMCLs) for improved methods for the batch control of recombinant interferon alfa-2 bulk and market surveillance testing of finished products, including those formulated with Human Serum Albumin (HSA)...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27506252/transferability-study-of-cho-cell-clustering-assays-for-monitoring-of-pertussis-toxin-activity-in-acellular-pertussis-vaccines
#9
R Isbrucker, A Daas, L Wagner, A Costanzo
Current regulations for acellular pertussis (aP) vaccines require that they are tested for the presence of residual or reversion-derived pertussis toxin (PTx) activity using the mouse histamine sensitisation test (HIST). Although a CHO cell clustering assay can be used by manufacturers to verify if sufficient inactivation of the substance has occurred in-process, this assay cannot be used at present for the final product due to the presence of aluminium adjuvants which interfere with mammalian cell cultures...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27506225/alternatives-to-hist-for-acellular-pertussis-vaccines-progress-and-challenges-in-replacement
#10
J Arciniega, L Wagner, R Prymula, P Sebo, R Isbrucker, B Descampe, J M Chapsal, A Costanzo, C Hendriksen, M Hoonaker, S Nelson, K Lidster, W Casey, D Allen
The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST' was held on 24 August 2014, in Prague, Czech Republic, as a satellite meeting to the 9th World Congress on Alternatives and Animal Use in the Life Sciences. Participants discussed the progress and challenges associated with the development, validation, and implementation of in vitro assays as replacements for the histamine sensitisation test (HIST) for acellular pertussis vaccines...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/27506140/alternative-to-ph-eur-pour-plate-method-for-detection-of-microbial-contamination-in-non-sterile-pharmaceutical-preparations
#11
A Palicz, A Paul, A Hofmann, K Denzel
The current European Pharmacopoeia (Ph. Eur.) texts for Interferon (IFN)-alfa-2 include a nonspecific photometric protein assay using albumin as calibrator and a highly variable cell-based assay for the potency determination of the protective effects. A request was expressed by the Official Medicines Control Laboratories (OMCLs) for improved methods for the batch control of recombinant interferon alfa-2 bulk and market surveillance testing of finished products, including those formulated with Human Serum Albumin (HSA)...
2016: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830170/collaborative-study-for-the-establishment-of-erythropoietin-brp-batch-4
#12
C Burns, A F Bristow, A Daas, A Costanzo
The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for erythropoietin (EPO) is used as a working standard for potency determination of EPO preparations by in vivo bioassay as prescribed in the Ph. Eur. monograph Erythropoietin concentrated solution (1316). The BRP batch 3 was calibrated in 2006 and its stocks are depleted. The European Directorate for the Quality of Medicines & HealthCare (EDQM) thus initiated a project to calibrate a replacement batch in International Units against the WHO 3(rd) International Standard (IS) for Erythropoietin, recombinant, for bioassay (11/170)...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830169/establishment-of-hepatitis-a-detection-antibodies-set-brr-batch-3-for-antigen-content-determination-by-elisa
#13
S Morgeaux, I Manniam, P Variot, A Daas, A Costanzo
The current batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Reagents (BRRs) used for the in vitro potency assay of hepatitis A vaccines (HAV) by ELISA (enzymelinked immunosorbent assay) was established in 2012 for use in conjunction with Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. It is composed of a coating reagent and a set of detection antibodies. As stocks of the latter are running low, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify replacement batches...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830168/collaborative-study-for-the-establishment-of-the-2-nd-international-standard-for-bleomycin-complex-a2-b2
#14
S Jorajuria, C Raphalen, V Dujardin, A Daas
Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 1(st) IS for bleomycin complex A2/B2 was used as a reference. Based on the results of the study, the 2(nd) IS for bleomycin complex A2/B2 was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2014 with an assigned potency of 12 500 International Units (IU) per vial...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830167/collaborative-study-for-the-establishment-of-the-4-th-international-standard-for-streptomycin
#15
S Jorajuria, C Raphalen, V Dujardin, A Daas
An international collaborative study was organised to establish the 4(th) World Health Organization (WHO) International Standard (IS) for Streptomycin. Fourteen laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 3(rd) IS for Streptomycin was used as a reference. Based on the results of the study, the 4(th) IS for Streptomycin was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2015 with an assigned potency of 76 000 International Units (IU) per vial...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830166/establishment-of-the-human-albumin-for-electrophoresis-ph-eur-brp-batches-3-and-4
#16
M-E Behr-Gross, A Daas, A Eulig-Wien, S Christians
Due to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human albumin for electrophoresis, the European Directorate for the Quality of Medicines & HealthCare (EDQM) initiated in 2014 an international collaborative study for the establishment of two replacement batches. The study was run under the aegis of the Biological Standardisation Programme (BSP). Thirteen laboratories participated in the collaborative study to verify the suitability of the candidate reference preparations according to the Ph...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830165/rationale-for-the-update-of-the-european-pharmacopoeia-general-chapter-2-2-48-raman-spectroscopy
#17
I R Lynch, W Schuh, W Kessler
Raman spectroscopy technique is widely used for the identification and characterisation of materials in the laboratory environment and, increasingly, for off-line, at-line, in-line and online Process Analytical Technologies (PAT) applications. The wide range of currently available Raman technologies had led to the requirement to update the existing General Chapter 2.2.48. The purpose of this reflection paper is to explain the rationale behind the establishment of the new wavenumber scale standards and peak position tolerances resulting from a multi-site, multi-instrument, inter-laboratory study of standards and, in particular, to discuss the results obtained with microscopes (including multi-point calibration) by the PAT Working Party...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830164/the-heavy-metals-cadmium-lead-and-mercury-in-raw-materials-of-animal-origin-evaluation-of-data-from-practice
#18
J Busch, M Knödler, M Kühn, A Lipinski, B Steinhoff
Raw materials from animal origin are widely used in homoeopathy. Due to the lack of dedicated limits, the quality requirements for herbal drugs of the European Pharmacopoeia (Ph. Eur.) and/or the German Homoeopathic Pharmacopoeia (Homöopathisches Arzneibuch, HAB), including limits for heavy metals such as cadmium, lead and mercury, have been applied. A recent database evaluation shows that for some raw materials of animal origin the Ph. Eur. limits for herbal drugs cannot be met in practice. For this reason proposals for new limits for cadmium, lead and mercury are made based on recent experiences from the companies' daily practice...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830163/pesticide-residues-in-essential-oils-evaluation-of-a-database
#19
B Klier, M Knödler, J Peschke, U Riegert, B Steinhoff
In the context of a revision of the European Pharmacopoeia (Ph. Eur.) general monograph Essential oils (2098), the need to include a test for pesticides is being discussed. According to published literature, some oils, mainly those produced by cold pressing (e.g. citrus oils), can contain relevant amounts of pesticide residues, whereas distilled oils showed positive findings in only a few cases. Recent evaluation of a database containing 127 517 sets of data compiled over 8 years, showed positive results in 1 150 cases (0...
2015: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/26830162/establishment-of-hepatitis-a-vaccine-inactivated-non-adsorbed-brp-batches-2-and-3
#20
S Morgeaux, I Manniam, P Variot, K H Buchheit, A Daas, M Wierer, A Costanzo
The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was calibrated in 2008 through an international collaborative study and was assigned a potency of 12 IU/mL. During use of this BRP it appeared to be inapplicable in certain cases due to a low nominal antigen content. Consequently, the European Directorate for the Quality of Medicines and HealthCare (EDQM) established replacement batches for this BRP, calibrated against the 1(st) WHO International Standard (IS) for HAV (inactivated), using the standard in vitro ELISA (enzyme-linked immunosorbent assay) method validated previously...
2015: Pharmeuropa Bio & Scientific Notes
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