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Les Ulis, France

Bardot I.,Pharmacie centrale des armees | Feraud I.,Capgemmi Industrie et Distribution | Neu E.,LFB | Romain J.-C.,Sanofi S.A. | And 2 more authors.
S.T.P. Pharma Pratiques | Year: 2010

This article is designed to transform regulatory requirements of product quality review (PQR) into an adaptable operational guide. Based on the experience of a sample of manufacturers and the work conducted by the SFSTP commission, a guide is proposed to allow a pragmatic approach to implementation of PQR by addressing the question: how to transform requirements into needs? Source

Bellon A.,LFB | Comoy E.,CEA Fontenay-aux-roses | Simoneau S.,LFB | Mornac S.,LFB | And 9 more authors.
Transfusion | Year: 2014

Background The high resistance of prions to inactivating treatments requires the proper management of decontaminating procedures of equipment in contact with materials of human or animal origin destined for medical purposes. Sodium hydroxide (NaOH) is widely used today for this purpose as it inactivates a wide variety of pathogens including prions. Study Design and Methods Several NaOH treatments were tested on prions bound to either stainless steel or chromatographic resins in industrial conditions with multiple prion strains. Results Data show a strong correlation between inactivation results obtained by immunochemical detection of the prion protein and those obtained with infectivity assays and establish effective inactivation treatments for prions bound to stainless steel or chromatographic resins (ion exchange and affinity), including treatments with lower NaOH concentrations. Furthermore, no obvious strain-specific behavior difference was observed between experimental models. Conclusion The results generated by these investigations show that industrial NaOH decontamination regimens (in combination with the NaCl elution in the case of the chromatography process) attain substantial prion inactivation and/or removal between batches, thus providing added assurance to the biologic safety of the final plasma-derived medicinal products. © 2013 American Association of Blood Banks. Source

Marie A.-L.,University Paris - Sud | Marie A.-L.,CNRS Galen Institute | Przybylski C.,CNRS Laboratory for Analysis and Modelling for Biology and Environment | Gonnet F.,CNRS Laboratory for Analysis and Modelling for Biology and Environment | And 6 more authors.
Analytica Chimica Acta | Year: 2013

The present study describes a reproducible and quantitative capillary zone electrophoresis (CZE) method, which leads to the separation of nine forms (native, oxidized and glycated) of human serum albumin (HSA). In an attempt to identify the different species separated by this CZE method, the capillary electrophoresis was coupled to mass spectrometry using a sheath liquid interface, an optimized capillary coating and a suitable CE running buffer. CE-MS analyses confirmed the heterogeneity of albumin preparation and revealed new truncated and modified forms such as Advanced Glycation End products (AGEs). Assignment of the CZE peaks was carried out using specific antibodies, carboxypeptidase A or sample reduction before or during the CE separation. Thus, five HSA forms were unambiguously identified. Using this CZE method several albumin batches produced by slightly different fractionation ways could be discriminated. Furthermore, analyses of HSA preparations marketed by five pharmaceutical industries revealed that two therapeutic albumins, including that marketed by LFB, contained the highest proportion of native form and lower levels of oxidized forms. © 2013 Elsevier B.V. Source

Marie A.-L.,CNRS Galen Institute | Tran N.T.,CNRS Galen Institute | Saller F.,University Paris - Sud | Saller F.,French Institute of Health and Medical Research | And 7 more authors.
Electrophoresis | Year: 2016

Antithrombin (AT) is a human plasma glycoprotein that possesses anticoagulant and anti-inflammatory properties. However, the native (active) form of AT is unstable and undergoes conformational changes, leading to latent, cleaved, and heterodimeric forms. The presence of these alternative forms mostly inactive can highly impact the quality and therapeutic activity of pharmaceutical AT preparations. We developed a capillary zone electrophoresis method, based on a neutral polyethylene oxide-coated capillary and a buffer close to physiological conditions, enabling the separation of more than eight forms of AT. Several peaks were identified as native, latent, and heterodimeric forms. The CZE method was reproducible with intraday relative standard deviations less than 0.5 and 2% for migration times and peak areas, respectively. The method was applied to the comparison of AT preparations produced by five competitive pharmaceutical companies, and statistical tests were performed. Important differences in the proportion of each form were highlighted. In particular, one AT preparation was shown to contain a high quantity of heterodimer, and two preparations contained high quantities of latent form. In addition, one AT preparation exhibited additional forms, not yet identified. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim Source

Marie A.-L.,University Paris - Sud | Marie A.-L.,CNRS Galen Institute | Tran N.T.,University Paris - Sud | Tran N.T.,CNRS Galen Institute | And 9 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2015

With the aim to determine the binding affinity of a new generation of recombinant antithrombin (AT) toward heparin, we developed a dynamic equilibrium-affinity capillary electrophoresis (DE-ACE) method. This method allows the determination of an AT-heparin binding constant (Kd) directly from the cell culture supernatant used to produce the AT variants. Eight measurements per AT variant are sufficient to determine an accurate Kd (uncertainty ≤22%, regression coefficient ≥0.97), which is not significantly different from the value obtained from a higher number of measurements. Due to the relatively short time required to determine the Kd of one AT variant (2h), this method has the potential for being a low throughput screening method. The method was validated by analyzing five AT variants, whose Kd have been reported in the literature using fluorescence spectroscopy. Finally, the method was applied to estimate the Kd of one new AT variant and one AT conformer, a latent form, that exhibits a significant loss of affinity. © 2015 Elsevier B.V. Source

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