Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation

Napawan Thangsupanimitchai; Alexander D. Edwards

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Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation

机译：在一次注射疫苗配方中均匀重构过滤干燥的蛋白抗原的均匀重构需要混合

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Ambient temperature filter dried vaccine formulations have been proposed to simultaneously achieve thermostability and offer a ready-to-use immunisation device that combines reconstitution and injection. Vaccine concentration should be uniform at the point of injection, but the uniformity following direct reconstitution of filter-dried vaccines has not been reported. We present here a study of vaccine mixing and release following dissolution of filter-dried model protein and toxoid antigens within a single syringe, filter and needle unit. Release was better for filters made from glass than cellulose. Without additional mixing, uniformity was poor and only 41% of input protein was released from protein filter-dried onto glass fiber. In contrast, adding a simple glass bead and mixing by inversion, 100% release antigen solution was achieved, with uniform concentration at exit from the needle throughout a simulated injection. Adsorption onto alum adjuvant had no detectable effect on vaccine dissolution and mixing. The uniformity and yield of low doses of diphtheria and tetanus toxoid was also improved by mixing, albeit with a lower yield of 60–68%. We conclude that uniformity and mixing should be studied to ensure safety and efficacy of directly reconstituted filter-dried vaccine formulations.

机译：已经提出了环境温度过滤器干燥的疫苗制剂以同时实现热稳定性，并提供结合重构和注射的即用的免疫装置。疫苗浓度应在注射点处均匀，但尚未报告过滤干燥的疫苗直接重建后的均匀性。我们在此提出疫苗混合的研究，并在单个注射器，过滤器和针单元内溶解过滤干燥的模型蛋白和毒素抗原后释放。从玻璃比纤维素制成的过滤器更好。不额外混合，均匀性差，只有41％的输入蛋白从蛋白质干燥到玻璃纤维上释放出来。相反，通过在整个模拟注射过程中，在达到100％释放抗原溶液中达到简单的玻璃珠和混合，在整个模拟注射时从针出均匀浓度。对alum佐剂的吸附对疫苗溶解和混合没有可检测的影响。通过混合，还提高了低剂量的白喉和破伤风毒素的均匀性和产量，尽管较低的产率为60-68％。我们得出结论，应研究均匀性和混合，以确保直接重构过滤干燥的疫苗制剂的安全性和功效。

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《Vaccine》 |2018年第33期|共7页
作者
Napawan Thangsupanimitchai; Alexander D. Edwards;
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作者单位

Reading School of Pharmacy University of Reading;

Reading School of Pharmacy University of Reading;

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正文语种 other
中图分类医学免疫学;
关键词
Formulation; Filter dried; Thermostabilised; Mixing; Adjuvant;

机译：配方;过滤干燥;热稳压;混合;佐剂;

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1. Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation [J] . Napawan Thangsupanimitchai, Alexander D. Edwards Vaccine . 2018,第33期

机译：在一次注射疫苗配方中均匀重构过滤干燥的蛋白抗原的均匀重构需要混合
2. Potential Hepatitis B Vaccine Formulation Prepared by Uniform-Sized Lipid Hybrid PLA Microparticles with Adsorbed Hepatitis B Surface Antigen [J] . Liu Qi, Chen Xiaoming, Jia Jilei, Molecular pharmaceutics . 2018,第11期

机译：均匀型脂质杂交PLA微粒制备潜在的乙型肝炎疫苗配方，其中具有吸附的乙型肝炎表面抗原
3. Vaccine-mediated protection of pigs against infection with pandemic H1N1 2009 swine influenza A virus requires a close antigenic match between the vaccine antigen and challenge virus [J] . Vaccine . 2019,第17期

机译：疫苗介导的猪免受大流行H1N1 2009猪流感的感染保护病毒需要疫苗抗原和攻击病毒之间的密切抗原匹配
4. FORMULATION DEVELOPMENT OF A RECOMBINANT PROTEIN BASED NON-REPLICATING ROTAVIRUS (NRRV) VACCINE CANDIDATE: ANTIGEN-ADJUVANT-PRESERVATIVE INTERACTIONS [C] . Sanjeev Agarwal, John M. Hickey, David McAdams, Conference on vaccine technology VI . 2018

机译：基于重组蛋白的非复制型轮状病毒（NRRV）候选疫苗的配方开发：抗原-佐剂-保藏相互作用
5. JC Virus small T antigen binds RB family proteins and the phosphatase PP2A and is required for efficient viral DNA replication activity. [D] . Hofstetter, Catherine A. 2009

机译：JC病毒小T抗原结合RB家族蛋白和磷酸酶PP2A，是有效的病毒DNA复制活性所必需的。
6. Biophysical and formulation studies of the Schistosoma mansoni TSP-2 extracellular domain recombinant protein a lead vaccine candidate antigen for intestinal schistosomiasis [O] . Weiqiang Cheng, Elena Curti, Wanderson C Rezende, 2013

机译：曼氏血吸虫TSP-2细胞外域重组蛋白（肠道血吸虫病的主要疫苗候选抗原）的生物物理和制剂研究
7. ABSTRACTudThe purpose of this research is to obtain an optimal formulations of Black mulberry leaves dried noodle product by using Design Expert Application with Design Mixture D-optimal method.udThis research was done with two phases. The preliminary procedures research is to determine levels of antioxidant activity, chlorophyll content, and the levels of tannin that was contained in black mulberry leaves, the black mulberry leaf flour, a pare fruits, and pare flour. Primary research is to determine the best formulation by using a Mixture Design Expert Design D-optimal method, for a purpose is to optimized the Black mulberry leaf dry noodle. Responses in this studies are a chemical analysis response by using a crude fiber analysis and protein analysis. Physical response is water absorption. Sensory response are color, flavor, and odor.udBlack mulberry leaves dried noodles was made from wheat flour, black mulberry leaf flour, and pare flour, other materials such as an eggs, water, salt, and sodium bicarbonate, of the 16 formulations that has offered to produce an optimal formulation based on desirability which contains 39.69 Flour,14.25 Black Mulberry Leaves flour, 3.06 Pare fruit and flour amounted, and other materials are 30 water, 10 eggs, 2 salt, and 1 sodium bicarbonate. The formulation has been result by program 11,05 crude fiber content, 12.93 protein, 274.31 water absorption, 4,31 for color attribute, 3,87 for taste attribute, and 3,71 for aroma attribute.ududKeyword: Black mulberry leaf dried noodles, optimization. [O] . Leti Nurlatifah Alumni, Yudi Garnida DS, Tantan Widiantara DS 2017

机译：抽象 ud本研究的目的是通过使用带有Design Mixture D-最优方法的Design Expert Application获得黑桑叶干面条产品的最佳配方。 ud这项研究分两个阶段进行。初步程序研究是确定抗氧化剂活性，叶绿素含量以及黑桑叶，黑桑叶粉，果皮和果皮中所含单宁的含量。首要研究是通过使用Mixture Design Expert Design D-optimal方法确定最佳配方，目的是优化黑桑叶干面条。本研究中的反应是通过使用粗纤维分析和蛋白质分析进行的化学分析反应。物理反应是吸水。感官反应是颜色，味道和气味。黑桑叶干面条由小麦粉，黑桑叶粉和削皮粉，鸡蛋，水，盐和碳酸氢钠等其他材料制成，这16种配方可根据需要提供最佳配方其中包含39.69％的面粉，14.25％的黑桑叶面粉，3.06％的去皮水果和面粉，其他材料是30％的水，10％的鸡蛋，2％的盐和1％的碳酸氢钠。该配方是通过程序11,05％的粗纤维含量，12.93％的蛋白质，274.31％的吸水率，4.31的颜色属性，3,87的味道属性和3,71的芳香属性得出的。 ud关键字：黑桑叶干面条，优化。
8. Antigenic Structure of Coxiella burnetii: A Comparison of Lipopolysaccharide andProtein Antigens as Vaccines against Q Fever [R] . Williams, J. C., Hoover, T. A., Waag, D. M., 1990

机译：Coxiella burnetii的抗原结构：脂多糖和蛋白抗原作为Q热疫苗的比较

Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation

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