BD Medical Pharmaceutical Systems

Le Pont-de-Claix, France

BD Medical Pharmaceutical Systems

Le Pont-de-Claix, France

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Chevolleau T.,BD Medical Pharmaceutical Systems | Jouffray S.,BD Medical Pharmaceutical Systems | Dimitrova M.N.,Biogen Idec
Journal of Pharmaceutical Sciences | Year: 2014

Prefilled syringes (PFSs) offer improvements in the delivery of drugs to patients compared with traditional vial presentations and are becoming necessities in an increasingly competitive biologics market. However, the development of a product in a PFS must take into account potential incompatibilities between the drug and the components of the syringe. One such component is silicone oil, which has previously been suggested to promote protein aggregation, loss of soluble protein, and an increase in the particulate content of injectable formulations. This study evaluated the particulate content in a model buffer system (polysorbate 80/phosphate-buffered saline) after agitation in glass syringes with a novel cross-linked silicone coating. We also evaluated the compatibility of two monoclonal antibodies with these syringes. We report that syringes with this novel coating, compared with standard siliconized syringes, exhibited reduced particle content and enhanced integrity of the lubricant layer as determined by reflectometry, optical microscopy, and time-of-flight secondary ion mass spectrometry measurements, while maintaining the desired functional properties of the syringe and the antibodies' stability profiles as determined by high-performance size-exclusion chromatography. Enhanced integrity of the lubricant coating led to significantly fewer subvisible particles in the liquid formulations, particularly after agitation stresses introduced by shipping of the syringes. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.


Bomsel M.,French National Center for Scientific Research | Bomsel M.,French Institute of Health and Medical Research | Bomsel M.,University of Paris Descartes | Tudor D.,French National Center for Scientific Research | And 26 more authors.
Immunity | Year: 2011

Human immunodeficiency virus (HIV)-1 is mainly transmitted mucosally during sexual intercourse. We therefore evaluated the protective efficacy of a vaccine active at mucosal sites. Macaca mulatta monkeys were immunized via both the intramuscular and intranasal routes with an HIV-1 vaccine made of gp41-subunit antigens grafted on virosomes, a safe delivery carrier approved in humans with self-adjuvant properties. Six months after 13 vaginal challenges with simian-HIV (SHIV)-SF162P3, four out of five vaccinated animals remained virus-negative, and the fifth was only transiently infected. None of the five animals seroconverted to p27. gag-SIV. In contrast, all 6 placebo-vaccinated animals became infected and seroconverted. All protected animals showed gp41-specific vaginal IgAs with HIV-1 transcytosis-blocking properties and vaginal IgGs with neutralizing and/or antibody-dependent cellular-cytotoxicity activities. In contrast, plasma IgGs totally lacked virus-neutralizing activity. The protection observed challenges the paradigm whereby circulating antiviral antibodies are required for protection against HIV-1 infection and may serve in designing a human vaccine against HIV-1-AIDS. © 2011 Elsevier Inc.


Narhi L.O.,Amgen | Corvari V.,Eli Lilly and Company | Ripple D.C.,U.S. National Institute of Standards and Technology | Afonina N.,Bristol Myers Squibb | And 19 more authors.
Journal of Pharmaceutical Sciences | Year: 2015

Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and products, it is important to harmonize nomenclature, experimental protocols, data analysis, and interpretation. In this manuscript on perspectives on subvisible particles in protein therapeutic drug products, we focus on the tools available for detection, characterization, and quantification of these species and the strategy around their application. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.


PubMed | Eli Lilly and Company, MedImmune, Pfizer, Amgen and 11 more.
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2015

Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous particulate matter) is an important aspect of the pharmaceutical development process for biotherapeutics. Health authorities have increased expectations for subvisible particle data beyond criteria specified in the pharmacopeia and covering a wider size range. In addition, subvisible particle data is being requested for samples exposed to various stress conditions and to support process/product changes. Consequently, subvisible particle analysis has expanded beyond routine testing of finished dosage forms using traditional compendial methods. Over the past decade, advances have been made in the detection and understanding of subvisible particle formation. This article presents industry case studies to illustrate the implementation of strategies for subvisible particle analysis as a characterization tool to assess the nature of the particulate matter and applications in drug product development, stability studies and post-marketing changes.


PubMed | Eli Lilly and Company, Hoffmann-La Roche, Pfizer, U.S. National Institute of Standards and Technology and 11 more.
Type: Journal Article | Journal: Journal of pharmaceutical sciences | Year: 2015

Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 m), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and products, it is important to harmonize nomenclature, experimental protocols, data analysis, and interpretation. In this manuscript on perspectives on subvisible particles in protein therapeutic drug products, we focus on the tools available for detection, characterization, and quantification of these species and the strategy around their application.


Laurent P.E.,BD Medical Pharmaceutical Systems | Bourhy H.,Institute Pasteur Paris | Fantino M.,University of Burgundy | Alchas P.,United Medical Systems | Mikszta J.A.,Research Triangle Park
Vaccine | Year: 2010

In the present pilot study, intradermal ID delivery systems with a BD microneedle from 1 to 3. mm in length, and epidermal delivery (BD skin abrader) through abraded skin surface relative to standard intramuscular injection were evaluated. Circulating neutralizing antibodies were measured against the rabies virus after the Vero cells rabies vaccine was administered at D0, D7, D21 and D49. This clinical evaluation in 66 healthy volunteers shows that ID delivery using BD microneedle technology of 1/4 the IM antigen dose is safe, efficient and reliable, resulting in a protective seroconversion rate. In contrast, the epidermal delivery route did not produce an immune response against the rabies vaccine. © 2010 Elsevier Ltd.


Maden A.,BD Medical Pharmaceutical Systems | O'Sullivan K.,BD Medical
ONdrugDelivery | Year: 2015

In this piece, Alice Maden, PharmD, Global and Regional Regulatory Affairs Manager, and Kathleen O’Sullivan, MS, RAC, Worldwide Director, Regulatory Affairs, both of BD Medical, take the practical example of a drug product filled in a BD Hypak™ glass prefillable syringe to describe how the worldwide regulatory environment of combination products has rapidly evolved. BD’s Regulatory Affairs team has adapted their support offerings and customised solutions to assist customers from the pharmaceutical and biotechnology industry to sustain this major change. © 2015 Frederick Furness Publishing Ltd.


Felsovalyi F.,Columbia University | Felsovalyi F.,United Medical Systems | Patel T.,Columbia University | Mangiagalli P.,BD Medical Pharmaceutical Systems | And 2 more authors.
Protein Science | Year: 2012

Gaining more insight into the mechanisms governing the behavior of proteins at solid/liquid interfaces is particularly relevant in the interaction of high-value biologics with storage and delivery device surfaces, where adsorption-induced conformational changes may dramatically affect biocompatibility. The impact of structural stability on interfacial behavior has been previously investigated by engineering nonwild-type stability mutants. Potential shortcomings of such approaches include only modest changes in thermostability, and the introduction of changes in the topology of the proteins when disulfide bonds are incorporated. Here we employ two members of the aldo-keto reductase superfamily (alcohol dehydrogenase, AdhD and human aldose reductase, hAR) to gain a new perspective on the role of naturally occurring thermostability on adsorbed protein arrangement and its subsequent impact on desorption. Unexpectedly, we find that during initial adsorption events, both proteins have similar affinity to the substrate and undergo nearly identical levels of structural perturbation. Interesting differences between AdhD and hAR occur during desorption and both proteins exhibit some level of activity loss and irreversible conformational change upon desorption. Although such surface-induced denaturation is expected for the less stable hAR, it is remarkable that the extremely thermostable AdhD is similarly affected by adsorption-induced events. These results question the role of thermal stability as a predictor of protein adsorption/desorption behavior. © 2012 The Protein Society.


Felsovalyi F.,Columbia University | Felsovalyi F.,United Medical Systems | Mangiagalli P.,BD Medical Pharmaceutical Systems | Bureau C.,BD Medical Pharmaceutical Systems | And 2 more authors.
Langmuir | Year: 2011

A central paradigm that underpins our understanding of the interaction of proteins with solid surfaces is that protein adsorption leads to changes in secondary structure. The bound proteins tend to denature, and these non-native, adsorbed structures are likely stabilized through the loss of α-helices with the concomitant formation of intermolecular β-sheets. The goal of this work is to critically assess the impact this behavior has on protein desorption, where irreversible conformational changes might lead to protein aggregation or result in other forms of instability. The adsorption, desorption, and structural transitions of lysozyme are examined on fumed silica nanoparticles as a function of the amount of protein adsorbed. Surprisingly, the data indicate not only that adsorption is reversible but also that protein desorption is predictable in a coverage-dependent manner. Additionally, there is evidence of a two-state model which involves exchange between a native-like dissolved state and a highly perturbed adsorbed state. Since the in situ circular dichroism (CD) derived secondary structures of the adsorbed proteins are essentially unaffected by changes in surface coverage, these results are not consistent with previous claims that surface-induced denaturation is coverage dependent. Inspired by results from homopolymer adsorption experiments, we speculate that more local descriptors, such as the number of amino acids per chain that are physically adsorbed on the surface, likely control the desorption process. © 2011 American Chemical Society.


PubMed | BD Medical Pharmaceutical Systems
Type: Comparative Study | Journal: Vaccine | Year: 2010

In the present pilot study, intradermal ID delivery systems with a BD microneedle from 1 to 3mm in length, and epidermal delivery (BD skin abrader) through abraded skin surface relative to standard intramuscular injection were evaluated. Circulating neutralizing antibodies were measured against the rabies virus after the Vero cells rabies vaccine was administered at D0, D7, D21 and D49. This clinical evaluation in 66 healthy volunteers shows that ID delivery using BD microneedle technology of 1/4 the IM antigen dose is safe, efficient and reliable, resulting in a protective seroconversion rate. In contrast, the epidermal delivery route did not produce an immune response against the rabies vaccine.

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