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Pharmeuropa Bio & Scientific Notes

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https://www.readbyqxmd.com/read/29944115/collaborative-study-for-the-establishment-of-human-immunoglobulin-brp-replacement-batches
#1
D Karra, E Regourd, A Costanzo
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...
2018: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29845933/replacement-reduction-refinement-animal-welfare-progress-in-european-pharmacopoeia-monographs-activities-of-the-european-pharmacopoeia-commission-from-2007-to-2017
#2
C Lang, O Kolaj-Robin, G Cirefice, L Taconet, E Pel, S Jouette, M Buda, C Milne, E Charton
Since the opening for signature of the European Convention for the Protection of Animals Used for Experimental and Other Scientific Purposes in 1986, the European Pharmacopoeia Commission and its experts have carried out a programme of work committed to Replacing, Reducing and Refining (3Rs) the use of animals for test purposes. While updates on achievements in the field of the 3Rs are regularly provided, this article summarises the activities of the Ph. Eur. Commission in this field within the last decade.
2018: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29325605/establishment-of-detection-antibodies-brrs-batch-4-for-in-vitro-potency-assay-of-hepatitis-a-vaccines-by-elisa
#3
S Morgeaux, A Koy, I Manniam, E Regourd, P Variot, A Costanzo
The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs). The 3rd batch of detection antibodies BRRs was established in 2015 for use in conjunction with the Ph. Eur. general chapter 2.7.14 'Assay of hepatitis A vaccine'. Stocks of these BRRs were running low and therefore the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify replacement batches...
2018: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29191266/assessment-of-uv-spectrophotometry-for-determination-of-plasmid-dna-concentration-in-vector-preparations-for-human-gene-therapy-products
#4
MULTICENTER STUDY
X Chenivesse, B Anliker, A Daas, S Ferro, R Meier, M Renner, A Costanzo
The European Pharmacopoeia (Ph. Eur.) general chapter 5.14. Gene transfer medicinal products for human use suggests the use of absorbance measurements at 260 nm to determine the DNA concentration of plasmid vectors used for the preparation of gene therapy products for human use. An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to confirm the suitability of UV spectrophotometry for the quantification of plasmid vectors used in gene therapy (GT)...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29143737/validation-of-elisa-methods-for-quantification-of-the-major-birch-allergen-bet-v-1-bsp090
#5
MULTICENTER STUDY
S Kaul, J Zimmer, O Dehus, A Constanzo, A Daas, K-H Buchheit, J Asturias, M C Arilla, D Barber, A Bertocchi, B Brunetto, J A Carnes, M Chapman, G Chaudemanche, J Dayan-Kenigsberg, S Döring, F Führer, M T Gallego, P Iacovacci, K M Hanschmann, T Holzhauser, M Hrabina, A Ledesma, P Moingeon, E Nony, C Pini, G Plunkett, M Raulf, G Reese, E Sandberg, I Sander, B Smith, D Strecker, C Valerio, R van Ree, B Weber, S Vieths
To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers with respect to strength and efficacy is impossible. The Biological Standardisation Programme (BSP) project BSP090 addresses this issue via the establishment of reference standards in conjunction with ELISA methods for the quantification of major allergens in allergen products...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29017703/establishment-of-the-ph-eur-hepatitis-a-virus-rna-for-nat-testing-brp-batch-1
#6
MULTICENTER STUDY
M Chudy, C M Nübling, J Blümel, A Daas, A Costanzo
Detection of viral contamination in plasma donations is critical to prevent transmission of infectious diseases. The European Pharmacopoeia (Ph. Eur.) monograph 1646 'Human plasma (pooled and treated for virus inactivation)', requires that plasma pools used for the manufacture of this product be tested, among others, for the presence of hepatitis A virus RNA by nucleic acid testing (NAT) using a positive control containing 100 International Units (IU) of hepatitis A virus (HAV) RNA per mL. To this end, the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) organised an international collaborative study under the aegis of the Biological Standardisation Programme, for the establishment of the 1st Biological Reference Preparation (BRP) for HAV RNA for NAT testing...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29017702/collaborative-study-on-saccharide-quantification-of-the-haemophilus-influenzae-type-b-component-in-liquid-vaccine-presentations
#7
MULTICENTER STUDY
U Rosskopf, A Daas, E Terao, C von Hunolstein
Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers use different methods to assay PRP content: a national control laboratory must establish and validate the relevant manufacturer methodology before using it to determine PRP content. An international study was organised by the World Health Organization (WHO), in collaboration with the Biological Standardisation Programme (BSP) of the Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the European Union Commission, to verify the suitability of a single method for determining PRP content in liquid pentavalent vaccines (DTwP-HepB-Hib) containing a whole-cell pertussis component...
2017: Pharmeuropa Bio & Scientific Notes
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
#8
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
#9
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 8th 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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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