Reflections on manufacturer′s reference materials of preventive human vaccines / 中国生物制品学杂志

@#Reference materials for vaccine are the standard rulers for quality control,dose determination and effectiveness evaluation of vaccines. Manufacturer's reference materials are a kind of the working standards that are directly used by vaccine enterprises in the process of production,quality control and evaluation,of which the accuracy and stability play a key role in ensuring the consistency between batches,safety and effectiveness of vaccines. Based on the investigation into the current management situation of manufacturer's reference materials in domestic representative vaccine enterprises,and combined with the relevant guidelines and regulations such as World Health Organization guidelines and Chinese Pharmacopoeia,this paper put forward the key points that should be considered in the establishment and application of manufacturer's reference materials of preventive human vaccines. It is also suggested to formulate the guidelines about manufacturer's reference materials in order to regulate the development and application of working reference materials.

Reflections on national reference materials of preventive human vaccines / 中国生物制品学杂志

@#The national standards for biological products include three types of reference materials,vaccines,biotherapeutics,and diagnostics,among which the national standards for vaccines play a crucial role in the production,issuance,and supervision inspection of vaccines. In recent years,the vaccine industry in China has developed rapidly,and especially,the application of new technology platforms such as mRNA in vaccines has highlighted the urgency of further improving the level of national standards for vaccines in China. Referring to WHO(World Health Organization)development requirements for reference materials of vaccines and taking Chinese national standard for SARS-CoV-2 neutralizing antibody as example,this paper summarized the thinking on national standards for vaccines in China,and presented the priority principles of establishing national standards for vaccines which are not traceable to WHO international standard(IS),in view to provide ideas for the further improvement of development and application of national standards for vaccines in China.

Desarrollo de un material de referencia certificado para análisis elemental de agua potable / Development of a certified reference material for elemental analysis of drinking wáter / Desenvolvimento de um material de referência certificado para análise elementar de água potável

Resumen La producción de un material de referencia (MR) es un proceso en el que se realizan estudios relacionados con la preparación, envasado y caracterización (incluye homogeneidad y estabilidad). En este trabajo se presentan los resultados del desarrollo de un MR de agua potable. El envasado se realiza aplicando dos procedimientos (envasado convencional e inmersión). La caracterización se realizó por Absorción Atómica, ICPMS y Cromatografía iónica. La evaluación de homogeneidad del material se realizó para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn y aniones como NO3 - y Cl-. La estabilidad se evaluó a corto (condiciones aceleradas) y largo plazo por ICPMS y CI, además se realizó seguimiento gravimétrico. La homogeneidad y estabilidad se evaluaron con base en su incertidumbre. La incertidumbre asociada a la homogeneidad y estabilidad MR evidenció resultados aceptables para la mayoría de los analitos. Los resultados del seguimiento gravimétrico permitieron detectar pérdidas de masa del material, por lo que se planteó un nuevo esquema para evaluar la estabilidad a través de métodos gravimétricos. Finalmente, se encontró que el MR presenta incertidumbres expandidas entre el 0,93% y el 4,38%, siendo apto para el uso previsto.

Abstract The production of reference materials (RM) is a process that involves carrying out different studies related to the preparation, packaging and chemical stability of the analytes. This paper presents the results of the development of a drinking water RM. The packaging is done by applying two procedures (conventional packaging and immersion). The characterization of this material was carried out through atomic absorption, ICPMS and ion chromatography. The assessment of the homogeneity of the material was carried out for Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn and anions as NO3 - y Cl-. The stability studies were evaluated in the short term (accelerated conditions), and long term by ICPMS and IC, and gravimetric monitoring was also performed. Homogeneity and stability were evaluated based on their uncertainty. The uncertainty associated with homogeneity and MR stability evidenced acceptable results for most analytes. The results of the gravimetric monitoring allowed to detect losses of mass of the material, reason why a new scheme was proposed to evaluate the stability through gravimetric methods. Finally, it was found that the RM presents expanded uncertainties between 0,93% and 4,38%, which makes it suitable for the intended use.

Resumo Este artigo apresenta os resultados do desenvolvimento de um MR de água potável. A embalagem é feita aplicando dois procedimentos (embalagem convencional e imersão). A caracterização foi realizada por Absorção Atômica, ICPMS e Cromatografia Iônica. A avaliação da homogeneidade do material foi realizada para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn e ânions como NO3 - y Cl-. A estabilidade foi avaliada em curto prazo (condições aceleradas) e em longo prazo pelo ICPMS e IC, e também foi realizada monitoração gravimétrica. A homogeneidade e estabilidade foram avaliadas com base na incerteza. A incerteza associada à homogeneidade e estabilidade da RM evidenciou resultados aceitáveis para a maioria dos analitos. Os resultados do monitoramento gravimétrico permitiram detectar perdas de massa do material, pelo que foi proposto um novo esquema para avaliar a estabilidade por métodos gravimétricos. Por fim, verificou-se que o RM apresenta incertezas expandidas entre 0,93% e 4,38%, sendo adequado para o uso pretendido.

Panorama general de los organismos genéticamente modificados en Colombia y en el mundo: Capacidad nacional de detección / Overview of genetically modified organisms in Colombia and worldwide: National detection capabilities

RESUMEN Los organismos genéticamente modificados (OGM) y en particular los cultivos genéticamente modificados (GM), son el resultado de la modificación de la información genética de una especie a partir del uso de la biotecnología moderna para proporcionar nuevas características que su contraparte no modificada no posee, tales como resistencia a insectos, tolerancia a herbicidas, contenido de nutrientes entre otros. La mayor parte de estos cultivos se concentran en cuatro productos: soya (Glycine max), maíz (Zea Mays), canola (Brassica napus) y algodón (Gossypium hirsutum); y los principales productores son Estados Unidos, Brasil, Argentina, India y Canadá. Por su parte, Colombia ocupa el puesto 18 con cultivos de maíz, algodón y claveles azules. La introd uc-ción de estas especies en cualquier mercado está limitada por la legislación propia del país destino, así como por los estudios que permiten establecer su efecto sobre el medio ambiente, la salud humana y animal; en este sentido, la precisión y confianza de las técnicas analíticas empleadas en la evaluación del contenido de OGM son un elemento importante para la toma de decisiones basadas en evidencias objetivas, especialmente frente al debate en torno a su uso. Este documento presenta una revisión de las tecnologías de análisis más importantes disponibles a nivel mundial, frente a las capacidades nacionales para su detección.

ABSTRACT Genetically modified organisms (GMO) and particularly genetically modified (GM) crops are the result of modifying the genetic information of a species through the use of modern biotechnology to provide new features that are nonexistent in the unmodified counterpart, such as resistance to insects, tolerance to herbicides, and nutrient content, among others. Most of these crops are concentrated in four products: soy (Glycine max), corn (Zea Mays), canola (Brassica napus) and cotton (Gossypium hirsutum), with the United States, Brazil, Argentina, India and Canada as their main producers. Colombia, meanwhile, ranks 18th worldwide, with corn, cotton and blue carnation crops. The introduction of these species into any market is limited by the legislation of the destination country, as well as by studies that can establish the effect of the GM crop on the environment and human and animal health. For this reason, the accuracy and reliability of analytical techniques used to evaluate GMO content are important for decisionmaking based on objective evidence, especially in terms of the debate surrounding their use. Therefore, the following document presents a review of the most important GM crop analysis technologies in the world, vis a vis national detection capabilities.

Development and verification of reference nucleic acid materials of H9N2 influenza viruses by real-time RT-PCR / 生物工程学报

The HA gene of H9N2 influenza virus (A/chicken/Hunan/04.14 (H9N2)) was amplified and sequenced. The RNA was synthesized by in vitro transcription. The RNA transcription solutions were diluted to 10⁹ copies/μL using the RNA storage solution. The aliquoted RNA solutions were used to evaluate the homogeneity and stability. The results were determined by the average value obtained from four independent laboratories. Furthermore, the fluorescence quantitative RT-PCR method was also developed to verify the detection accuracy of clinical samples. The detection limit of this method is approximately 10 copies. Taken together, the RNA transcription solution established in our study can used as positive standard reference for rapid detection of H9N2 influenza virus.

Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships

Characterized reference materials (RMs) are needed for clinical laboratory test development and validation, quality control procedures, and proficiency testing to assure their quality. In this article, we review the development and characterization of RMs for clinical molecular genetic tests. We describe various types of RMs and how to access and utilize them, especially focusing on the Genetic Testing Reference Materials Coordination Program (Get-RM) and the Genome in a Bottle (GIAB) Consortium. This review also reinforces the need for collaborative efforts in the clinical genetic testing community to develop additional RMs.

Preparation and Certification of Reference Materials for 3-Amino-2-oxazolidinone Residue in Eel Muscle Lyophilisates / 分析化学

A methodology for preparing and certifying the reference material of 3-amino-2-oxazolidinone(AOZ) in eel muscle lyophilisates was presented. Furazolidone was accessed to eel by dipping fish in pond with furazolidone solution at a dosage of ca 0.16 mg/L. With the metabolism of furazolidone in eel, the muscles contain a certain concentration of AOZ as furazolidone metabolite was obtained. Lyophilization of the muscles was performed in one batch and 400 bags of samples were obtained by the procedure of homogenation, cryodesiccation and irradiation. The homogeneity and stability of the sample was examined. The value of the chemical constituent of the sample was certified through the collaborative analysis program participated by 11 laboratories using isotope dilution liquid chromatography-tandem mass spectrometry, and the uncertainty assessment was performed. The reference materials have been approved as certified reference materials by AQSIQ, China (State General Administration of the People′s Republic of China for Quality Supervision and Inspection and Quarantine) in 2009 after one year of trial period. The serial numbers is GBW(E)100180.

Preparation of Five China Sea and Continental Shelf Sediment Reference Materials with Ultra Fine Particle Size / 分析化学

The preparation and certification of five China Sea and continental shelf sediment reference materials MSCS-1- 5 are reported. The raw samples were collected separately from the East China Sea and the South China Sea. First,they were ground by a ball mill to a homogenous powder of less than 74μm,then these samples was further processed by an ultra-fine processing technique,a jet mill,to form an ultra-fine powder. The particle size distribution of the samples was determined with a laser particle-analyser,their average particle size is < 4μm. The homogeneity was tested by high-precision WD-XRF and the minimum sampling mass is 5 mg,which was confirmed by XRF,ICP-AES and ICP-MS. Twelve laboratories participated in the cooperative study and 60 constituents were determined. 50 and 51 components were certified as certified values and 1 and 2 components as reference values respectively for MSCS-1 and MSCS-2,52 constituents were certified as certified values for MSCS-3,4 and 5. The sum of the major and minor components in the five reference materials MSCS-1 -5 is 99.9% ,99.6% ,100.4% ,100.1% and 99.7% ,respectively.

Propuesta preliminar de adquisición de publicaciones seriadas primarias para RESUMED

Preliminary Proposal of Acquisitions of Primary Serial Publications for RESUMED. Selecting publications for the creation of a journal of abstracts is a complex and arduous task if it is taken into account the geometrical growth of the scientific literature and the budget cuts for adquisition that most information institutions currently face. A basic set of primary serial publications was chosen for its processing in RESUMED, the journal of abstracts that the National Center of Information on Medical Sciences publishes for the primary health care sector. With this goal, the Center drew an initial proposal based in the informetric criteria. Afterwards, the criterion of a sample of experts in the discussed issues was consulted. A list of 86 titles that embraces a preliminary selection of publications whose works must be analysed with the aim of processing its abstracts was obtained. The complementing of assesment by information specialists with that of experts in the studied disciplines constitutes a reasonable way for determining the information sources with the highest quality and usefulness.

Establishment of quality assurance system for Chinese materia medica by measuring traceable theory and method / 中草药

Chinese materia medica (CMM) as well as its interrelated industries has huge exploitable potential and developing prospect At present, it has become one of the directions with the worldwide exploitation of new medicine and development in medicinal industry The establishment of quality standard system of CMM in China is one of the key problems that the modernization of them should be first of all resolved In order to ensure the accuracy, credibility, comparability and mutual recognition of data examined by each laboratory, our research should be based on the international theory and method of the traceability Our government and CMM administration department should strengthen the esablishment and promulgation of criteria, laws, regulations of CMM and its interrelated industries, so as to make the quality assurance system approach to the international standard, and to protect our economic benefits, people's health and most consumers' interests from being affected