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National Institute for Food and Drug Co... Publications | LitMetric

218 results match your criteria: "National Institute for Food and Drug Control[Affiliation]"

HSV-1/hPD-1 is composed of engineered herpes simplex virus type-1 and two inserted copies of the human PD-1 antibody sequence. It is a novel oncolytic virus product designed to cure malignancies. The objective of this study was to estimate its toxicity in mice.

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Potent Anti-SARS-CoV-2 Efficacy of COVID-19 Hyperimmune Globulin from Vaccine-Immunized Plasma.

Adv Sci (Weinh)

May 2022

China National Biotec Group Company Limited, Beijing, 100029, China.

Coronavirus disease 2019 (COVID-19) remains a global public health threat. Hence, more effective and specific antivirals are urgently needed. Here, COVID-19 hyperimmune globulin (COVID-HIG), a passive immunotherapy, is prepared from the plasma of healthy donors vaccinated with BBIBP-CorV (Sinopharm COVID-19 vaccine).

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To date, the coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has determined 399,600,607 cases and 5,757,562 deaths worldwide. COVID-19 is a serious threat to human health globally. The World Health Organization (WHO) has declared COVID-19 pandemic a major public health emergency.

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• An infectious cDNA clone of CV-B5 was constructed. • The rescued and parental virus possessed similar biological characteristics. • The virulence of the rescued virus was similiar to that of the parental virus.

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The continuous emergence of SARS-CoV-2 variants highlights the need of developing vaccines with broad protection. Here, according to the immune-escape capability and evolutionary convergence, the representative SARS-CoV-2 strains carrying the hotspot mutations were selected. Then, guided by structural and computational analyses, we present a mutation-integrated trimeric form of spike receptor-binding domain (mutI-tri-RBD) as a broadly protective vaccine candidate, which combined heterologous RBDs from different representative strains into a hybrid immunogen and integrated immune-escape hotspots into a single antigen.

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To assess the immunogenicity and safety of a booster vaccination with an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The phase Ⅱ trial of an inactivated SARS-CoV-2 vaccine was conducted by Jiangsu Provincial Center for Disease Control and Prevention (CDC) since October 2020. The subjects were healthy adults aged 18-59 years, excluding pregnant, and not breastfeeding women.

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[12]aneN-Conjugated AIEgens with two-photon imaging properties for synergistic gene/photodynamic therapy and .

J Mater Chem B

February 2022

China National Institute for Food and Drug Control, Institute of Chemical Drug Control, No. 31 Huatuo St., Daxing District, Beijing, 102629, China.

Six amphiphiles (TTC-L-M-1/2/3/4/5/6), each consisting of hydrophilic macrocyclic polyamine triazole-[12]aneN (M) and a hydrophobic photosensitizer tetraphenylethenethiophene modified cyanoacrylate (TTC) moiety linked with alkyl chains (L), have been designed and synthesized for synergetic anticancer gene therapy and photodynamic therapy (PDT). These amphiphiles showed strong AIE fluorescence emissions around 600 nm with large Stokes shifts up to 168 nm in an aqueous solution. They were able to condense DNA into nanoparticles with appropriate sizes, positive charges, reversible release, and good biocompatibility.

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Although a plethora of gene carriers have been developed for potential gene therapy, imageable stimuli-responsive gene vectors with fast access to the nucleus, high biocompatibility, and transfection efficiency are still scarce. Herein, we report the design and synthesis of four dendrite-shaped cationic liposomes, /DOPE (R: -butyl, ; -octyl, ; -dodecyl, ; palmyl, ), prepared via esterification of 4-alkoxybenzylideneimidazolinone containing aliphatic chains of different lengths (HBI-R), the green fluorescent protein (GFP) chromophore, with a di[12]aneN unit. Liposomes were fabricated the self-assembly of , assisted with 1,2-dioleoyl--glycerol-3-phosphorylethanolamine (DOPE).

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Stimuli-responsive drug delivery systems (DDSs) based on amphiphilic polymers have attracted much attention. In this study, we reported an innovative HO-responsive amphiphilic polymer (TBP), bearing a HO-sensitive phenylboronic ester, AIE fluorophore tetraphenylethene (TPE) hydrophobic, and polyethylene glycol hydrophilic (PEG) moieties. TBP could self-assemble into micelles with an encapsulation efficiency as high as 74.

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Analysis of the batch issued data of Chinese vaccines from 2011 to 2020 showed that the average annual dose of vaccines in China was 769.66 million doses, and the overall production was stable. Fourteen new vaccines were added, six of which were developed in China.

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COVID-19 pandemic has severely impacted the public health and social economy worldwide. A safe, effective, and affordable vaccine against SARS-CoV-2 infections/diseases is urgently needed. We have been developing a recombinant vaccine based on a prefusion-stabilized spike trimer of SARS-CoV-2 and formulated with aluminium hydroxide and CpG 7909.

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Objective: To study the safety of alginate based gastric mucosal protective adhesive and its feasibility as a submucosal injection.

Methods: The feasibility of using alginate-based gastric mucosal protective gel as submucosal injection was evaluated by gastric mucosal uplift test in pigs and in vivo gastric mucosal uplift test in rats. The safety of alginate based gastric mucosa protective adhesive was evaluated by cytotoxicity test, acute toxicity test and oral mucosa stimulation test according to GB/T 16886 series standard of biological evaluation of medical devices.

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What Is Already Known On This Topic?: The global burden of chronic obstructive pulmonary disease (COPD) is serious. Pneumococcal infection is associated with acute exacerbations of COPD (AECOPD). The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for COPD patients to decrease AECOPD due to pneumococcus, but evidence on the immunogenicity of PPSV23 in COPD patients is limited.

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Background: Although SARS-CoV-2 infection often causes milder symptoms in children and adolescents, young people might still play a key part in SARS-CoV-2 transmission. An efficacious vaccine for children and adolescents could therefore assist pandemic control. For further evaluation of the inactivated COVID-19 vaccine candidate BBIBP-CorV, we assessed the safety and immunogenicity of BBIBP-CorV in participants aged 3-17 years.

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Degradable cationic polyesters via ring-opening copolymerization of valerolactones as nanocarriers for the gene delivery.

Bioorg Chem

November 2021

Shandong Provincial Engineering Laboratory of Novel Pharmaceutical Excipients, Sustained and Controlled Release Preparations, College of Medicine and Nursing, Dezhou University, Dezhou 253023, PR China.

The development of cationic polymers as non-viral gene vectors has been hurdled by their high toxicity, thus degradable and biocompatible polymers are urgently demanded. Herein, five polyesters (B3a-B3e) were synthesized based on the ring-opening copolymerization between α-allyl-δ-valerolactone and δ-valerolactone derivatives decorated with alkyl or alkoxyl chains of different lengths, followed by the modification with 1,5,9-triazacyclododecyl ([12]aneN) through thiol-ene click reactions. The five polyesters effectively condensed DNA into nanoparticles.

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The lung is an important organ in systemic toxicity test of medical devices and is significant in safety evaluation. Based on the authors' understanding of medical devices, this study provides a brief analysis of the lung examination and common problems in systemic toxicity, so as to provide references for the pre-clinical safety evaluation of medical devices. It should be noted that a reasonable risk assessment should be made after comprehensive assessment for specific medical device products.

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PharmDE: A new expert system for drug-excipient compatibility evaluation.

Int J Pharm

September 2021

State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences (ICMS), University of Macau, Macau, China. Electronic address:

Drug-excipient compatibility study is the essential basis for excipient selection at the pre-formulation stage. According to the pharmaceutical Quality by Design (QbD) principles, a comprehensive understanding of the ingredients' physicochemical properties and a theoretical evaluation of the interaction risk between the drugs and excipients are required for conducting rational compatibility experimental design. Currently, there is an urgent need to establish an artificial intelligence system for researchers to easily get through the problem because it is very inconvenient and hard to utilize those drug-excipient incompatibility data scattered in scientific literature.

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Direct comparison of two kinds of linoleic acid-docetaxel derivatives: in vitro cytotoxicity and in vivo antitumor activity.

Drug Deliv Transl Res

May 2022

Department of Pharmaceutics, Wuya College of Innovation, Shenyang Pharmaceutical University, Shenyang, 110016, People's Republic of China.

Rational designed lipid-drug derivatives provide a favorable approach to improve the druggability of highly hydrophobic prototypes. It has been regarded as common sense that good cytotoxicity is the guarantee of superior anticancer efficacy for candidate derivatives screening. However, does it apply to lipid-drug conjugate-based self-assembled nanoparticles? Here, we established the above two derivatives and a non-correlation between the cytotoxic activity in vitro and drug efficacy in vivo was found.

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COVID-19 vaccines from multiple manufacturers are needed to cope with the problem of insufficient supply. We did two single-center, randomised, double-blind, placebo-controlled phase 1 and phase 2 trials to assess the safety, tolerability and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older in China. Eligible participants were enrolled, the ratio of candidate vaccine and placebo within each dose group was 3:1 (phase 1) or 5:1 (phase 2).

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Global concerns arose as the emerged and rapidly spreading SARS-CoV-2 variants might escape host immunity induced by vaccination. In this study, a heterologous prime-boost immunization strategy for COVID-19 was designed to prime with a DNA vaccine encoding wild type (WT) spike protein receptor-binding domain (RBD) followed by S1 protein-based vaccine in rabbits. Four vaccine-elicited rabbit monoclonal antibodies (RmAbs), including 1H1, 9H1, 7G5, and 5E1, were isolated for biophysical property, neutralization potency and sequence analysis.

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A core-shell structured COVID-19 mRNA vaccine with favorable biodistribution pattern and promising immunity.

Signal Transduct Target Ther

May 2021

NHC Key Laboratory of Biosafety, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.

Although inoculation of COVID-19 vaccines has rolled out globally, there is still a critical need for safe and effective vaccines to ensure fair and equitable supply for all countries. Here, we report on the development of a highly efficacious mRNA vaccine, SW0123 that is composed of sequence-modified mRNA encoding the full-length SARS-CoV-2 Spike protein packaged in core-shell structured lipopolyplex (LPP) nanoparticles. SW0123 is easy to produce using a large-scale microfluidics-based apparatus.

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Two-photon fluorescent Acenaphtho[1,2-b]quinoxaline (ANQ) and the hydrophilic di-(triazole-[12]aneN) moieties were combined through an alkyl chain (ANQ-A-M) or a β-hairpin motif with two aromatic γ-amino acid residues (ANQ-H-M) to explore their capabilities for in vitro and in vivo gene delivery and tracing. ANQ-A-M and ANQ-H-M showed the same maximum absorption at 420 nm, and their fluorescent intensities around 650 nm were varied in different solvents and became poor in the protic solvents. Gel electrophoresis assays indicated that both compounds completely retarded the migration of pDNA at 20 μM in the presence of DOPE.

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Calcium phosphate cement (CPC) modified with native and pregelatinized normal corn and waxy maize starches was studied. Effects of starch pregelatinization and starch type on the physicochemical properties of CPC were investigated. CPC modified with pregelatinized normal corn starch (CPB-PNC) or pregelatinized waxy maize starch (CPB-PW) was evaluated by two vertebral fracture surgical models in vitro.

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Current evidence on the immunogenicity of influenza vaccination in patients with chronic obstructive pulmonary disease (COPD) is limited. To address this need for additional knowledge, we conducted a study on the immunogenicity of trivalent seasonal influenza vaccine (TIV) in COPD patients. We recruited patients from respiratory outpatient clinics of three hospitals in Tangshan, Hebei province who had stable confirmed COPD, were less than 80 y old, and reported not having had influenza or receiving TIV during the study season prior to enrollment.

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Two-Photon Near-Infrared AIE Luminogens as Multifunctional Gene Carriers for Cancer Theranostics.

ACS Appl Mater Interfaces

May 2021

China National Institute for Food and Drug Control, Institute of Chemical Drug Control, Tian Tan XiLi 2, Beijing 100050, China.

Construction of multifunctional nonviral gene vectors to execute defined tasks holds great potential for the precise and effective treatment of gene-associated diseases. Herein, we have developed four large π-conjugation triphenylamine derivatives bearing two polar [12]aneN heads and a lipophilic tail for applications in gene delivery, one/two-photon-triggered near-infrared (NIR) fluorescence bioimaging, and combined photodynamic therapy (PDT) and gene therapy of cancer. These compounds possess typical NIR aggregation-induced emission characteristics, mega Stokes shifts, strong two-photon excitation fluorescence, and excellent DNA condensation abilities.

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