Biologicals : Journal of the International Association of Biological StandardizationThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

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Validation of a simple, rapid and cost effective method for the estimation of caprylic acid and sodium caprylate from biological products using NEFA-C kit.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In conclusion the validated method was successfully used in monitoring of processed bulk and final products generated during production of biological products thus laying emphasis on strict control of release criteria for biological products fractionated using caprylic acid. PMID: 19919899 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - November 16, 2009 Category: Biotechnology Authors: Athavale M, Fernandes A, Kaundinya J, Daftary G Tags: Biologicals Source Type: journals

A mouse-based assay for the pre-clinical neurovirulence assessment of vaccinia virus-based smallpox vaccines.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Post-vaccinal encephalitis, although relatively uncommon, is a known adverse event associated with many live, attenuated smallpox vaccines. Although smallpox vaccination ceased globally in 1980, vaccine manufacture has resumed in response to concerns over the possible use of smallpox virus as an agent of bioterrorism. To better support the production of safer smallpox vaccines, we previously reported the development of a mouse model in which a relatively attenuated vaccine strain (Dryvax((R))) could be discerned from a more virulent laboratory strain (WR). Here we have further tested the performance of this assay by ev...
Source: Biologicals : Journal of the International Association of Biological Standardization - November 5, 2009 Category: Biotechnology Authors: Zhang CX, Sauder C, Malik T, Rubin SA Tags: Biologicals Source Type: journals

Cloning, high level expression and immunogenicity of 1163-1256 residues of C-terminal heavy chain of C. botulinum neurotoxin type E.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In conclusion, availability of the recombinant protein provides an effective system to study the biochemical and physical interactions involved during BoNT binding to nerve cells and protection against its toxicity. PMID: 19879159 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - October 28, 2009 Category: Biotechnology Authors: Mansour AA, Mousavi SL, Rasooli I, Nazarian S, Amani J, Farhadi N Tags: Biologicals Source Type: journals

Guidelines on stability evaluation of vaccines.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: PMID: 19875304 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - October 27, 2009 Category: Biotechnology Tags: Biologicals Source Type: journals

Removal of TSE agents by depth or membrane filtration from plasma products.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The removal of the abnormal form of prion protein i.e. PrP(SC) by filtration steps in the plasma fractionation process has been investigated by immuno-Western blotting. Depth filtration has been shown to be capable of removing scrapie by 2-3log from certain plasma product intermediates. These include cryoprecipitate supernatant, used for the manufacture of immunoglobulin and albumin, and albumin fraction V, by filtration using Pall Seitz or 3m Cuno depth filters respectively. However no significant removal occurred with immunoglobulin Fraction II after Cuno depth filtration. When 0.2mum PVDF and Nylon membrane filters ...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 23, 2009 Category: Biotechnology Authors: Roberts PL, Evans D, Harris L Tags: Biologicals Source Type: journals

Consideration on a few aspects of the stability studies post licensure.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Stability studies represent a significant workload for both manufacturers and regulatory reviewers and therefore a careful selection of the study design and of the stability indicator test is required to make sure that the study will provide the relevant information. Moreover, alternatives to the existing regulatory approaches should be favoured in order to better or quicker analyze the impact of a specific change. In this article, examples of alternative approaches are given. For the stability monitoring study, emphasis is put on the bulk stability program. Concerning comparability stability study, two case studies il...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 21, 2009 Category: Biotechnology Authors: Pierard I, Spelte G, Le Tallec D, Duchêne M Tags: Biologicals Source Type: journals

An annual vaccine: Seasonal influenza.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The accelerated development process for annual vaccines such as seasonal influenza presents unique challenges for the evaluation of vaccine stability. Real-time real-condition studies provide limited information at the time of registration, while regulators seek evidence that the current vaccine will perform satisfactorily in the field. Participants in the IABS Workshop on Stability Evaluation of Vaccines, a Life Cycle Approach, were offered a case study from the development of the 2007 influenza vaccine. The case study was introduced with preliminary data from the long-term study, as well as results from the completed...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 20, 2009 Category: Biotechnology Authors: Jivapaisarnpong T, Krause PR Tags: Biologicals Source Type: journals

A vaccine measured with a highly variable assay: Rabies.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Manufacturers and regulators are challenged when evaluating stability of vaccines when potency is measured using a highly variable assay. Participants in the IABS Workshop on Stability Evaluation of Vaccines, a Life Cycle Approach, were offered a case study from a series of stability studies of a rabies vaccine, using the NIH potency assay. The case study was introduced with a scenario in which a new manufacturer was to formulate, lyophilize and fill the vaccine from bulk supplied by another manufacturer. The regulatory authority requested that data from the new manufacturer be supplied, to supplement that of the origi...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 18, 2009 Category: Biotechnology Authors: Jivapaisarnpong T, Schofield T, Krause PR Tags: Biologicals Source Type: journals

The effect of salt concentration on the prekallikrein activator assay.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19828329 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - October 11, 2009 Category: Biotechnology Authors: Georgakopoulos T, Hayes TK, Bertolini J Tags: Biologicals Source Type: journals

Evaluation of cell substrates for the production of biologicals: Revision of WHO recommendations Report of the WHO Study Group on Cell Substrates for the Production of Biologicals, 22-23 April 2009, Bethesda, USA.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Evaluating cell substrates for producing vaccines and other biologicals is one of the critical aspects in assuring quality and safety of these products. As part of its mission in setting standards for biological products, WHO provides recommendations for manufacturing and evaluating biologicals. Regular updates of the guidance documents are important to manufacturers and regulators worldwide. WHO Expert Committee on Biological Standardization (ECBS) identified a need for revising the requirements for cell substrates (WHO TRS 878, annex 1). In response, WHO established a Study Group (SG) in 2006 that prepared an update...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 6, 2009 Category: Biotechnology Authors: Knezevic I, Stacey G, Petricciani J, Sheets R, Tags: Biologicals Source Type: journals

Stability evaluation of vaccines.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19783158 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - September 24, 2009 Category: Biotechnology Authors: Schofield T, Krause PR Tags: Biologicals Source Type: journals

Characterization of variant diphtheria toxin-interleukin-3 fusion protein, DTIL3K116W, for phase I clinical trials.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We have produced clinical grade of DTIL3K116W, a variant diphtheria toxin-interleukin-3 fusion protein, for treatment of acute myeloid leukemia. The product was filter sterilized, aseptically vialed, and stored at -80 degrees C. It was characterized by Coomassie-stained SDS-PAGE, endotoxin assay, cytotoxicity assay, sterility, mass spectroscopy, receptor binding affinity, ADP-ribosylation, inhibition of normal human CFU-GM, disulfide bond analysis, immunoblots, stability, size exclusion chromatography-HPLC, sequencing, and immunohistochemistry. Vialed product was sterile in 0.25M NaCl/5mM Tris, pH 7.9, and had a protei...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 21, 2009 Category: Biotechnology Authors: Su Y, Li SY, Ghosh S, Ortiz J, Hogge DE, Frankel AE Tags: Biologicals Source Type: journals

WHO/KFDA workshop on stability evaluation of vaccines, Seoul, Korea, 23-25 April 2008.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In April 2008, the World Health Organization and the Korea Food & Drug Administration jointly organized a workshop on evaluating vaccine stability. The main objective of the workshop was to facilitate implementing newly established WHO guidelines. The value of stability studies in understanding vaccine characteristics, establishing shelf-life and release specifications, and monitoring the stability post-market was well explained. Optimal designs for goal-based stability studies were proposed and appropriate statistical analyses presented. A statistical model (the term "estimation model" was adopted) based on regres...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 21, 2009 Category: Biotechnology Authors: Shin J, Smith D, Southern J, Knezevic I Tags: Biologicals Source Type: journals

Goals of stability evaluation throughout the vaccine life cycle.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle. At and after licensure, stability studies on quality attributes (including potency) provide a critical link between marketed and clinically evaluated vaccine product, addressing important regulatory concerns by assuring that product quality is maintained throughout the dating period. During development, stability studies are done to assure product quality and to obtain the data needed to support licensure. Stability studies may also be performed after licensure to assure that product continues to perform as it di...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 20, 2009 Category: Biotechnology Authors: Krause PR Tags: Biologicals Source Type: journals

Stability of vaccines - Bridging from stability data to continuous safety and efficacy throughout shelf life - An always reliable approach?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Stability studies are important tools to reliably ensure that efficacy and safety of medicinal products will remain unchanged from release of drug product until the end of shelf life. For complex medicinal products such as biological medicinal products, including vaccines, design and conduct of such studies requires particularly careful considerations in order to ensure that technical data resulting from stability studies are indeed indicative for unchanged clinical performance. Ideally, relevance of specifications controlled by stability studies as well as definition of shelf life should be justified by acceptable cli...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 18, 2009 Category: Biotechnology Authors: Pfleiderer M Tags: Biologicals Source Type: journals

Combined vaccines - Case study.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Application of the principles outlined in the WHO Guideline on Stability Evaluation of Vaccines is complicated by the nature of combination vaccines. Differences in degradation rates among the immunogens impose the restriction that shelf life is based on the most labile component. There is also a testing challenge with numerous components held at different stages of production. PMID: 19758822 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - September 13, 2009 Category: Biotechnology Authors: Jivapisarnpong T Tags: Biologicals Source Type: journals

Panel discussion.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19747847 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - September 8, 2009 Category: Biotechnology Authors: Smith Moderator D, Duchene M, Egan W, Jivapaisarnpong T, Knezevic I, Pierard I, Schofield T, Shin J, Southern J, Krause PR, Rapporteur Tags: Biologicals Source Type: journals

Stability evaluation of vaccines: WHO approach.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article provides basic information about WHO international standards as well as key definitions and principles for stability evaluation of vaccines that are elaborated in detail in the above mentioned guidance document. PMID: 19729320 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 31, 2009 Category: Biotechnology Authors: Knezevic I Tags: Biologicals Source Type: journals

Model format for a vaccine stability report and software solutions.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A session of the International Association for Biologicals Workshop on Stability Evaluation of Vaccine, a Life Cycle Approach was devoted to a model format for a vaccine stability report, and software solutions. Presentations highlighted the utility of a model format, that will conform to regulatory requirements and the ICH common technical document. However, there need be flexibility to accommodate individual company practices. Adoption of a model format is premised upon agreement regarding content between industry and regulators, and ease of use. Software requirements will include ease of use and protections against ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 28, 2009 Category: Biotechnology Authors: Shin J, Southern J, Schofield T Tags: Biologicals Source Type: journals

Influence of ethanol on the release of growth factors in human blood-derived platelet gels.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In conclusion, ethanol has a significant impact on the amount of GF released by platelets and should be strictly controlled to standardize PG and optimize clinical benefits. PMID: 19720546 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 28, 2009 Category: Biotechnology Authors: Kuo YP, Lee YL, Tseng YH, Su CH, Burnouf T, Su CY Tags: Biologicals Source Type: journals

Basic principles of stability.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
An understanding of the principles of degradation, as well as the statistical tools for measuring product stability, is essential to management of product quality. Key to this is management of vaccine potency. Vaccine shelf life is best managed through determination of a minimum potency release requirement, which helps assure adequate potency throughout expiry. Use of statistical tools such a least squares regression analysis should be employed to model potency decay. The use of such tools provides incentive to properly design vaccine stability studies, while holding stability measurements to specification presents a d...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 28, 2009 Category: Biotechnology Authors: Egan W, Schofield T Tags: Biologicals Source Type: journals

Stability post-licensure: Compatvibility container content - A practical case study.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Numerous variations to a manufacturing process may take place during the life cycle of a vaccine. To support these variations, the regulator requires providing stability data according to the existing ICH guidelines; these have been designed for documenting the licence of a new vaccine. Comparative studies and adapted stability designs specific to the variation will give far more confidence to the manufacturer and the regulator than the classical model. The following case study applied to a change of a stopper illustrates this approach. PMID: 19717309 [PubMed - as supplied by publisher] (Source: Biologicals : Journ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 27, 2009 Category: Biotechnology Authors: Duchêne M, Jeanmart L, Slegers B Tags: Biologicals Source Type: journals

Stability testing of vaccines: Developing Countries Vaccine Manufacturers' Network (DCVMN) perspective.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Stability testing is an integral part of the vaccine manufacturing process and is crucial for the success of immunization programs. WHO (World Health Organization) has recently published guidelines on the stability testing of vaccines. These guidelines enlist scientific basis and principles for stability testing at various stages like development, pre-clinical, clinical, licensing, lot release and post-licensure monitoring. DCVMN (Developing Countries Vaccine Manufacturers' Network) is an international body of developing countries vaccine manufacturers and has viewpoints on technical and administrative issues in stabil...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 27, 2009 Category: Biotechnology Authors: Jadhav SS, Dogar V, Gautam M, Gairola S Tags: Biologicals Source Type: journals

Maintenance of vaccine stability through annual stability and comparability studies.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Evaluation of vaccine stability does not end with licensure of the product. An annual stability program helps assure continued quality of product throughout the dating period, while comparability studies are performed after a process or facilities change in order to demonstrate that the change has not impacted the stability characteristics of the product. Careful attention to the design and analysis of post licensure studies helps mitigate the risk of missing a meaningful shift in the degradation rate of a vaccine, as well as the possibility of incorrectly earmarking a stability shift when the product remains acceptabl...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 27, 2009 Category: Biotechnology Authors: Schofield TL Tags: Biologicals Source Type: journals

Vaccine stability study design and analysis to support product licensure.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Stability evaluation supporting vaccine licensure includes studies of bulk intermediates as well as final container product. Long-term and accelerated studies are performed to support shelf life and to determine release limits for the vaccine. Vaccine shelf life is best determined utilizing a formal statistical evaluation outlined in the ICH guidelines, while minimum release is calculated to help assure adequate potency through handling and storage of the vaccine. In addition to supporting release potency determination, accelerated stability studies may be used to support a strategy to recalculate product expiry after ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 27, 2009 Category: Biotechnology Authors: Schofield TL Tags: Biologicals Source Type: journals

The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
An in vitro potency test has recently been included in the European Pharmacopoeia (EP) monograph (01/2007:0870) to assess the potency of inactivated Newcastle disease (ND) vaccines. This enzyme linked immunosorbent assay (ELISA) is an attractive alternative for the existing in vivo potency tests especially with regard to the objective of the European Authorities to Replace, Reduce and Refine the use of laboratory animals for production and quality control of immunobiologicals. In the present study the influence of the inactivant on the antigen content established by ELISA was evaluated. Therefore, oil based vaccines co...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 25, 2009 Category: Biotechnology Authors: Jagt HJ, Bekkers ML, van Bommel SA, van der Marel P, Schrier CC Tags: Biologicals Source Type: journals

Testing genotoxicity and cytotoxicity strategies for the evaluation of commercial radiosterilized fetal calf sera.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Effects of 18 commercial lots of fetal calf serum (FCS) after gamma-irradiation and their non-irradiated counterparts were comparatively analyzed on CHO-K1 and MDBK MDL1 cells for genotoxicity [sister chromatid exchange (SCE), micronuclei (MNi), and single cell gel electrophoresis (SCGE)], cytotoxicity [cell-cycle progression (CCP), proliferative replication index (PRI), mitotic index (MI), growth promotion (GP), and plating efficiency (PE)], and microbiological properties (mycoplasma and bovine viral diarrhea virus contamination). SCE and SCGE were the most informative end-points for genotoxicity since significant dif...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 25, 2009 Category: Biotechnology Authors: Pilili JP, González NV, Molinari G, Reigosa MA, Soloneski S, Larramendy ML Tags: Biologicals Source Type: journals

Nomenclature and guideline to express the amount of a membrane protein synthesized in animal cells in view of bioprocess optimization and production monitoring.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Studies of a bioprocess optimization and monitoring for protein synthesis in animal cells face a challenge on how to express in quantitative terms the system performance. It is possible to have a panel of calculated variables that fits more or less appropriately the intended goal. Each mathematical expression approach translates different quantitative aspects. We can basically separate them into two categories: those used for the evaluation of cell physiology in terms of product synthesis, which can be for bioprocess improvement or optimization, and those used for production unit sizing and for bioprocess operation. Wi...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 18, 2009 Category: Biotechnology Authors: Augusto EF, Moraes AM, Piccoli RA, Barral MF, Suazo CA, Tonso A, Pereira CA Tags: Biologicals Source Type: journals

Multiplex RT Q-PCR assay for simultaneous quantification of three viruses used for validation of virus clearance by biopharmaceutical production.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Virus removal studies are used to insure the safety of biopharmaceutical products by quantitatively estimating the viral clearance capacity by the manufacturing process. Virus quantification assays are used to measure the log(10) clearance factor of individual purification unit operations in spike recovery studies. We have developed a multiplex RT Q-PCR assay that detects and quantifies three commonly used model viruses X-MuLV, SV40, and MMV simultaneously. This RT Q-PCR multiplex assay has a 6log(10) dynamic range with a limit of detection (LOD) of approximately 1 genome copy/muL. Amplification profiles are similar to...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 13, 2009 Category: Biotechnology Authors: Lute S, Wang H, Sanchez D, Barletta J, Chen Q, Brorson K Tags: Biologicals Source Type: journals

The methodological approach for the generation of humandendritic cells from monocytes affects the maturation state of the resultant dendritic cells.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dendritic cells (DCs) are effective as antigen-presenting cells in the immune system and are present at two functional stages depending on their maturation state. For experimental investigation of this concept, CD14(+) monocytes from blood are isolated and cultured to generate in vitro the DCs needed for functional analysis. For positive selection of CD14(+) monocytes we compared two immunomagnetic bead technologies: MACS((R)) Separation, created by Miltenyi Biotec, and EasySep((R)) Selection, created by StemCell Technologies. The monocytes provided dendritic cells for their functional analysis. Lipopolysaccharide was ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 6, 2009 Category: Biotechnology Authors: Mucci I, Legitimo A, Compagnino M, Consolini R, Migliaccio P, Metelli MR, Scatena F Tags: Biologicals Source Type: journals

Review of regulation of biological and biotechnological products in Latin American and Caribbean countries.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The objective of this publication is to present the current picture of biotechnological and biological product regulation in the Latin American and Caribbean Region, in order to offer guidance that will facilitate the regulation of these products in a harmonized manner among the countries of the Member States, as well as responding to the request from some regulatory agencies to address the growing demand for licensing applications of these products. PMID: 19664935 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 4, 2009 Category: Biotechnology Authors: Pombo ML, Di Fabio JL, Cortés MD Tags: Biologicals Source Type: journals

Parametric and non-parametric prediction intervals based phase II control charts for repeated bioassay data.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Quality control for repeated bioassay runs can be performed by phase II control charts, well-known from industrial quality control. The value of interest is the potency, of which a single value per run is available. Parametric and non-parametric prediction intervals are described to estimate quality control intervals for future re-test runs. Violations against the normal distribution occur in real data frequently, particularly outliers. The non-parametric prediction intervals are limited to not too small sample sizes in both the historical and future sampling phases. Therefore, robust prediction intervals based on wins...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2009 Category: Biotechnology Authors: Hothorn LA, Gerhard D, Hofmann M Tags: Biologicals Source Type: journals

Virus & TSE safety forum 2008.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Virus & TSE safety forum 2008. Biologicals. 2009 Jul 29; Authors: Robertson JS, Blümel J, Brorson K, Gröner A, Kreil TR, Ruiz S, Willkommen H PMID: 19646899 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - July 28, 2009 Category: Biotechnology Authors: Robertson JS, Blümel J, Brorson K, Gröner A, Kreil TR, Ruiz S, Willkommen H Tags: Biologicals Source Type: journals

Human antibody Fc deamidation in vivo.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Protein and peptide deamidation occurs spontaneously in vitro under relatively mild conditions. For antibodies and other therapeutic proteins, great effort is placed in manufacturing and storage to minimize this form of degradation. Concern has been especially great in cases where deamidation has been shown to impact protein activity. Here we monitored asparagine deamidation from a recombinant human antibody in humans and found that among the conserved sites, only Asn 384 deamidated at an appreciable rate. Under physiological temperature and pH conditions, in vitro antibody deamidation followed similar kinetics, indica...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 13, 2009 Category: Biotechnology Authors: Liu YD, van Enk JZ, Flynn GC Tags: Biologicals Source Type: journals

Assessment of the impact of solvent/detergent treatment on the quality and potency of a whole IgG equine antivenom.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We have evaluated for the first time the impact of a solvent/detergent (S/D) treatment on the quality and in vivo neutralization potency of horse-derived whole IgG antivenom used in the treatment of viperid snake bite envenoming in Central America. The S/D treatment by 1% tri (n-butyl) phosphate (TnBP) - 1% Triton X-45 at 22-25 degrees C was applied either on starting plasma or on purified immunoglobulins. The S/D agents were removed from both fractions by extractions with oil. S/D-treated plasma was subjected to caprylic acid precipitation to purify the immunoglobulins. Products were formulated, sterile-filtered, and ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 17, 2009 Category: Biotechnology Authors: Segura A, León G, Su CY, Gutiérrez JM, Burnouf T Tags: Biologicals Source Type: journals

Standardization and validation of Vero cell assay for potency estimation of diphtheria antitoxin serum.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Diphtheria toxin has the capacity to block protein synthesis in cultured mammalian cells, and thus causing cell death. This capacity of diphtheria toxin was utilized for in-vitro neutralization test to determine antibody titer, using Vero cells, which have been found to be susceptible to diphtheria toxin. In the present study, a Vero cell assay was standardized and validated for potency estimation of diphtheria antitoxin serum (DATS). The results obtained by Vero cell assay were compared with in-vivo biological assay. High degree of correlation (+0.98) was found between in-vivo biological assay and in-vitro Vero cell a...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 16, 2009 Category: Biotechnology Authors: Kumar S, Kanwar S, Bansal V, Sehgal R Tags: Biologicals Source Type: journals

Human papillomavirus vaccines: WHO position paper.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19525124 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - June 11, 2009 Category: Biotechnology Authors: Duclos P Tags: Biologicals Source Type: journals

Emerging markets & emerging needs: developing countries vaccine manufacturers' perspective & its current status.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Emerging markets & emerging needs: developing countries vaccine manufacturers' perspective & its current status. Biologicals. 2009 Jun;37(3):165-8 Authors: Jadhav SS, Gautam M, Gairola S The success of vaccination has remained an important contribution towards public health in both industrialised and developing countries. However, there are still unmet public health needs in vaccine preventable diseases owing to issues related to affordability, supply, public awareness, research and development, intellectual property, skilled human resource, etc. Various global initiatives are being taken to tackle such...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Jadhav SS, Gautam M, Gairola S Tags: Biologicals Source Type: journals

Adjuvants and formulations: how to make an immunogen from an antigen.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Appropriate adjuvants and formulations improve the immunogenicity of antigens, by increasing both the intensity and duration of immune responses. To that aim, the design and use of adjuvants must obey to the rules regulating physiological responses of the immune system, in particular the long-term development of memory lymphocytes. Here I will briefly discuss the main mechanisms of adjuvanticity at the light of recent knowledge on antigen presentation by B memory lymphocytes, the role of nonspecific stimulation of such cells for memory persistence, and the use of particulate antigens to target B cells, thus facilitatin...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Virelizier JL Tags: Biologicals Source Type: journals

The cotton rat model of respiratory viral infections.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Development of successful vaccines against human infectious diseases depends on using appropriate animal models for testing vaccine efficacy and safety. For some viral infections the task is further complicated by the frequently changing genetic make-up of the virus, as in the case of influenza, or by the existence of the little-understood phenomenon of vaccine-enhanced disease, as in the case of respiratory syncytial virus (RSV). The cotton rat Sigmodon hispidus has been used for years as an excellent small animal model of the RSV vaccine-enhanced disease. Recently, using cotton rats, we have demonstrated that vaccina...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Boukhvalova MS, Prince GA, Blanco JC Tags: Biologicals Source Type: journals

The Brazilian vaccine manufacturers' perspective and its current status.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article aims to give an overview of the current situation and perspectives for the Brazilian vaccine manufacturers, who play strong roles for developing countries in this field. The research, development and production of immunobiologicals in Brazil, especially vaccines for human use, is mainly supported by governmental institutions linked to the Ministry of Health as part of a strategy that prioritizes the public sector for access to vaccines and other biologicals that are regarded essential for the population. As a result, 83% of the vaccines required in 2007 were provided by national vaccine producers and only 17% ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Homma A Tags: Biologicals Source Type: journals

China's growing biomedical industry.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The biomedical industry in China is developing rapidly, and new biological drugs are increasing their share of the pharmaceutical market based on people's needs. China is the largest producer and user of vaccines in the world, but the existing production of vaccines is far from enough to meet the needs of the market. The entire market of biological drugs in China is still smaller than that for traditional medicines and chemicals. Therefore, the biopharmaceutical industry has the potential to be the rising star in the pharmaceutical market in the future. PMID: 19427231 [PubMed - in process] (Source: Biologicals : Jo...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Han P Tags: Biologicals Source Type: journals

Factors effecting expression of vaccines in microalgae.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PhycoBiologics is developing an oral vaccine delivery system using vaccines expressed in the chloroplast of microalgae. Despite many advances in plastid transformation technology, levels of expression remain inconsistent. We have concluded that the main factors affecting the level of recombinant protein expression in the chloroplast of Chlamydomonas are: codon optimization, protease activity, protein toxicity and transformation-associated genotypic modification. PMID: 19467445 [PubMed - in process] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2009 Category: Biotechnology Authors: Surzycki R, Greenham K, Kitayama K, Dibal F, Wagner R, Rochaix JD, Ajam T, Surzycki S Tags: Biologicals Source Type: journals

Long-term stability studies on protection against Newcastle disease by commercial live vaccine used in Brazil.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The thermostability (TS) and efficacy offered by live vaccines against Newcastle disease strains B1, La Sota, VG-GA and Ulster, produced or imported by four Brazilian laboratories, were evaluated during their validity period. Kinetic profiles were obtained from samples conserved in refrigerators during 0, 4, 8, 12, 16, 20 and 24 months after their manufacturing. The statistical analysis of the vaccine titre effect obtained by the fresh air (FA) method showed that the vaccine profiles were parallel and coincident, presenting a significant descending trend. The vaccine titres and efficiency proofs at the end of the valid...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 19, 2009 Category: Biotechnology Authors: Orsi MA, Zaroni MM, Doretto Júnior L, Camillo SC, Ribeiro SA, Rosado Spilki F, Buzinaro MD, Arns CW Tags: Biologicals Source Type: journals

Efficient expression of foreign genes in CHO DHFR(-) cellsby electroporation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DHFR-deficient Chinese hamster ovary (CHO DHFR(-)) cells are the most popular mammalian expression system for inducible amplification of transgene. In order to obtain more stable transfected CHO DHFR(-) cell clones, transfection efficiency of electroporation under different conditions were systemically investigated using plasmid pSV-beta-Gal as reporter gene. Transfection efficiency was proportionally increased with pulse duration and number of pulse applied. In addition, higher transfection efficiency was found in high salt extracellular solution (Berg's and Hank's buffers) than in intracellular solution (cytomix buff...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 18, 2009 Category: Biotechnology Authors: Lin WZ, Lee SS, Cheung WT Tags: Biologicals Source Type: journals

Quantitative determination of the infectivity of the proviral DNA of a retrovirus in vitro: Evaluation of methods for DNA inactivation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
All viral vaccines contain contaminating residual DNA derived from the production cell substrate. The potential risk of this DNA, particularly when derived from tumorigenic cells, has been debated for over 40 years. While the major risk has been considered to be the oncogenicity of the DNA, another potential risk is that a genome of an infectious virus is present in this DNA. Such a genome might generate an infectious agent that could establish an infection in vaccine recipients. To determine the quantity of a retroviral provirus in cellular DNA that can establish a productive infection in vitro, we developed a transfe...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 18, 2009 Category: Biotechnology Authors: Sheng-Fowler L, Lewis AM, Peden K Tags: Biologicals Source Type: journals

Adjuvant effect of bovine heat shock protein 70 on piroplasm surface protein, p33, of Theileria sergenti.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, we investigated the immunological effects of bovine heat shock protein 70 (HSP70) on the major Theileria sergenti surface protein (p33). The gene encoding p33 was expressed as a fusion protein with bovine HSP70 from a plasmid vector. The adjuvant function of HSP70 on p33 was evaluated with regard to antibody response, cytokine production, and a challenge experiment in mice or cattle. HSP-p33 fusion protein provoked higher humoral and cellular immunity than either Escherichiacoli-expressed p33 or piroplasm soluble protein. The HSP adjuvant activity toward p33 was also possible to detect in the inoculated catt...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 12, 2009 Category: Biotechnology Authors: Jeong W, Kweon CH, Kang SW, Lee HS, Xu Y, Lu C, Zhang S, Nene V Tags: Biologicals Source Type: journals

Development and validation of a reverse phase HPLC method for the determination of caprylic acid in formulations of therapeutic immunoglobulins and its application to antivenom production.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A novel method of high performance liquid chromatography with UV detection for the quantification of caprylic acid in formulations of therapeutic immunoglobulins was developed and validated. Samples have interfering proteins that were removed by ultrafiltration in a centrifugal filter unit of 10kDa nominal molecular weight limit. Then, compounds present in ultrafiltrates were separated on an Eclipse XDB-C8 5mum column (150mmx4.6mm i.d.), using a mixture of acetonitrile-water (60:40, v/v) as the mobile phase at a flow rate of 1mL/min. The UV detection was performed at 210nm. The method was found to be precise and accura...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 16, 2009 Category: Biotechnology Authors: Herrera M, Meneses F, Gutiérrez JM, León G Tags: Biologicals Source Type: journals

Evaluation of two human plasma pools as candidate international standard preparations for syphilitic antibodies.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A collaborative study was designed to asses two freeze-dried human plasma preparations containing anti-Treponema pallidum antibodies, 05/132 and 05/122, for their suitability as international reference reagents for syphilis serology. Both preparations are intended as replacements of the first international standard (IS) for syphilitic serum antibodies (HS). Samples were tested by eight laboratories using the T. pallidum passive particle agglutination assay (TPPA), the venereal disease research laboratory test (VDRL) and the rapid plasma reagin test (RPR). In addition a range of immunoassays was also used. The outcome o...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 16, 2009 Category: Biotechnology Authors: Rigsby P, Ison C, Brierley M, Ballard R, Hagedorn HJ, Lewis DA, Notermans DW, Riis J, Robertson P, Seppälä IJ, Rijpkema S Tags: Biologicals Source Type: journals

Cluster characterization of mouse embryonic stem cell-derived pluripotent embryoid bodies in four distinct developmental stages.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, the morphological characteristics and gene expression patterns of EBs related to the sequential stages of embryonic development were well defined in four distinct developmental groups over 112 days of culture: early-stage EBs groups (1-7 days of differentiation), mid-stage EBs groups (9-15 days of differentiation), maturing EBs groups (17-45 days of differentiation) and matured EBs groups (50 days of differentiation). We first determined definite histological location of apoptosis within EBs and the sequential expression of molecular markers representing stem cells (Oct4, SSEA-1, Sox-2 and AKP), germ cells (...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 30, 2009 Category: Biotechnology Authors: Qin J, Guo X, Cui GH, Zhou YC, Zhou DR, Tang AF, Yu ZD, Gui YT, Cai ZM Tags: Biologicals Source Type: journals