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• 2018 Volume 49 Issue 02
  Published: 10 February 2018

    

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  Perspectives & Review
  Paper
  Pharmaceutical Management & Information
  

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Perspectives & Review
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  Perspectives & Review

  A Review of 3D Printing Models in the Pharmaceutical Field

  JIA Danyang, LI Qijun, SUN Zhongyi, CAI Xiaohan, XIANG Rongwu*

  2018, 49(02): 135. https://doi.org/10.16522/j.cnki.cjph.2018.02.001

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  Perspectives & Review

  Research Progress in Pulsatile Drug Delivery System

  YANG Chen, QI Xiaole, WU Zhenghong*

  2018, 49(02): 142. https://doi.org/10.16522/j.cnki.cjph.2018.02.002

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  Pulsatile drug delivery system (PDDS) is designed on the basis of the theory of chronopharmacology to control drug release time, release site and doseage, in order to meet the changes in physiological rhythms to achieve the best effect. By consulting recent domestic and international literatures, we summarizes the features and release mechanisms of PDDS and concluded the research progress of new dosage forms based on various mechanisms. With the development of medicine and pharmacy, more deep and perfect researches on PDDSs will be conducted. PDDS will take greater advantages in clinical application.
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  Perspectives & Review

  Progress of Buccal Bioadhesive Polymers

  LIU Renliang, MA Jinlong*, NI Rui, SHI Jiajun, XU Yi

  2018, 49(02): 149. https://doi.org/10.16522/j.cnki.cjph.2018.02.003

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  Buccal delivery is considered a convenient route for the administration of drugs intended for both local and systemic delivery. Buccal mucoadhesive drug delivery systems (BMDDS) are drug-loading carriers with the buccal bioadhesive function, which can persistently adhere to oral mucosa and thus continue to release drug to administration place. Buccal bioadhesive polymer is the crucial point for BMDDS to achieve sustained adherence and release. This paper
  illustrates the similarities and differences between buccal bioadhesive polymers and other bioadhesive polymers, lists the advantages of BMDDS, describes characteristics of oral mucosa and the basic situation of mucoadhesion, reviews the bioadhesive polymers commonly used in buccal mucoadhesive delivery and summaries some of the commercial buccal mucoadhesive formulations.
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  Paper

  Pilot Scale Treatment of Spiramycin Fermentation Wastewater in Four-stage Anaerobic System (FSAS)

  LIU Pengyu1, SHAO Lei1, YAO Jian2, CHEN Jiarong1, CHEN Daijie1,3*

  2018, 49(02): 156. https://doi.org/10.16522/j.cnki.cjph.2018.02.004

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  To improve the anaerobic digestion efficiency of spiramycin fermentation wastewater, the stability and performance of a pilot-scale four-stage anaerobic system (FSAS) were studied at different organic loading rates (OLR) for 134 d. In the process of OLR lifting, indicators such as pH value, chemical oxygen demand (COD), and spiramycin concentration were observed. The results showed that when the average influent COD was 11 320 mg/L at the hydraulic
  retention time (HRT) of 12 d, the average effluent COD was 1 023 mg/L and COD removal efficiency reached 91％.In the anaerobic digestion, it was found that spiramycin was degraded from 41.8 mg/L to 11.3 mg/L and its antibacterial activity could not be detected through antimicrobial susceptibility testing after the treatment by FSAS. In the process of spiramycin wastewater treatment, FSAS had the advantage of high COD removal efficiency and residual spiramycin
  degradation, which could provide some guidance for the anaerobic treatment of antibiotic wastewater.
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  Paper

  Improved Synthesis of Ezetimibe

  ZHANG Yuncai, ZHANG Fan

  2018, 49(02): 163. https://doi.org/10.16522/j.cnki.cjph.2018.02.005

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  (4S)-3-[4-[2-(4-fluorophenyl)-5,5-dimethyl-1,3-dioxan-2-yl]butyryl]-4-phenyl-2-oxazolidinone(3) was treated by N-(4-fluorophenyl)-4-benzoxymethylenimine (5) to yield (4S)-3-[(2R,3S)-[3-(4-fluorophenyl)amino-2-[[2-(4-fluorophenyl)-5,5-dimethyl-1,3-dioxan-2-yl]ethyl]-3-(4-benzoxy)phenyl]propionyl]-4-phenyl-2-oxazolidinone (6) by Mannich addition. In the synthesis of compound 6, benzoyl group was utilized for the protection of hydroxyl group, which was readily cleavable without affecting subsequent reaction; Notably, when the reaction temperature was reduced from -10～0 ℃ reported by literature to -60～-50 ℃, the ratio of generated diastereomer was decreased from 25％ to 9％, and the yield was improved from 40％ to 60％. Next, (3R,4S)-1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-oxopropyl]-4-(4-hydroxyphenyl)azetidine-2-one (7) was obtained by the "one pot" method of cyclization of compound 6 and deprotection. Finally, ezetimibe was obtained by chiral catalytic reduction of compound 7 with the total yield of39.1％(based on 3).
   
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  An Improved Process of Empagliflozin

  WANG Xiaobo, HAN Shuo, WANG Jianyao, CHEN Dong*

  2018, 49(02): 167. https://doi.org/10.16522/j.cnki.cjph.2018.02.006

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  A process of empagliflozin (1) was improved. 1-C-[4-Chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]-oxy]phenyl]methyl]phenyl]-2,3,4,6-tetra-O-(trimethylsilyl)-α-D-glucopyranoside (4) was prepared via Grignard reaction starting from (S)-3-[4-(5-iodo-2-chlorobenzyl)phenoxy]tetrahydrofuran (2), and compound 4 was separated and purified, which was beneficial for the quality control of the final product. Then compound 4 was subjected to deprotection and methylation to give methyl 1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]-phenyl]-α-D-glucopyranoside (5); the work-up was optimized, and the desmethyl impurity 1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-α-D-glucopyranoside (4a) was reduced from about 10％ to less than 0.5％. Finally, the target compound 1 was obtained via a reduction of compound 5 by triethyl silane/trichloride aluminium with a total yield of 23.4％(based on 2) and a purity of 99.9％. The improved process has some advantages, such as short route, simple operation, and higher purity, which is more suitable for scale-up production.
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  A Novel Synthetic Process of Diflunisal

  LIU Qiulian

  2018, 49(02): 172. https://doi.org/10.16522/j.cnki.cjph.2018.02.007

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  A novel synthetic process of diflunisal (1) was reported. 2-Chloro-5-bromobenzonitrile (3) was prepared via bromination by N-bromosuccinimide from 2-chlorobenzonitrile (2). Then 3 coupled with (2,4-difluorophenyl)boronic acid (4) catalyzed by bis(triphenylphosphine)dichloronickel which formed by nickel
  chloride hexahydrate and triphenylphosphine to afford 4-chloro-2',4'-difluoro-(1,1'-biphenyl)-3-carbonitrile (5). Finally, compound 5 was subjected to hydrolysis in autoclave to prepare 1 with an overall yield of 63.1％(based on 2). This new process has some advantages, such as mild reaction conditions and simple operation, which are more suitable for commercial production.
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  Paper

  An Improved Process of Acipimox

  CHEN Wenhua, CHEN Huiru, ZHANG Yuxiu

  2018, 49(02): 175. https://doi.org/10.16522/j.cnki.cjph.2018.02.008

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  An improved synthetic process of acipimox (1) was reported. Excessive 2,5-dimethylpyrazine (2)reacted with potassium permanganate in water via oxidation to afford 5-methylpyrazine-2-carboxylic acid (3) with a purity of 99.4％ in 80％ yield. The excess compound 2 can improve the selectivity of monomethyl oxidation and can be recycled by azeotropic distillation. Next, compound 3 was oxidized by hydrogen peroxide with sodium tungstate as the catalyst in water to prepare the target compound with a total yield of 70％(based on 2) and a purity of 99.6％. This process has some advantages, such as green solvent (water) and less amount of potassium permanganate, high yield, simple and safe operation, low cost, etc., and it has been tested in pilot scale.
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  Paper

  Synthesis of Azacyclonol

  SUN Xingshen1, YAN Guigang2, LONG Zhongzhu2, TENG Dawei1*

  2018, 49(02): 178. https://doi.org/10.16522/j.cnki.cjph.2018.02.009

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  An efficient synthesis of α,α-diphenyl-4-piperidinomethanol (azacyclonol), the key intermediate for the synthesis of antihistamine agents such as fexofenadine hydrochloride and terfenadine, was developed. 4-Piperidinecarboxylic acid reacted with cathyl chloride in methanol via esterification and N-protection to give methyl N-ethoxycarbonyl-4-piperidinecarboxylate. Then the latter was subjected to the Grignard reaction with phenylmagnesium bromide followed by hydrolysis to prepared the target compound with a total yield of 68.8％. The raw material of this synthetic process is cheap and easy to get, the synthetic route is short, and the operation is simple.
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  Paper

  Screening of High-yield Ascomycin-producing Strain by UV Combined with ARTP Mutation

  REN Linying1, ZHANG Zhulan1*, WANG Desen1,2, YANG Huangjian1, LIAN Yunyang1

  2018, 49(02): 181. https://doi.org/10.16522/j.cnki.cjph.2018.02.010

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  The spore suspension of ascomycin producing strain Streptomyces hygroscopicus was mutated by ultraviolet (UV) and atmospheric and room temperature plasma (ARTP), and a high-yield mutant strain Streptomyces hygroscopicus FIM-38-24 was obtained through primary screening and rescreening by flask shaking fermentation. The content of ascomycin was determined by HPLC. The results showed that the ascomycin production capacity of the mutant
  FIM-38-24 (568.0 μg/ml) was 4 times of that of the original strain.
   
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  Optimization of the SPG Membrane Emulsification Solvent Extraction Method for Preparation of Triptorelin Pamoate PLGA Microspheres

  WU Xuesong1, XU Mingxin1, GUO Bosong2, JIN Tuo1*

  2018, 49(02): 186. https://doi.org/10.16522/j.cnki.cjph.2018.02.011

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  Preparation of Meloxicam Nanosuspensions with pH-dependent Dissolving-precipitating Method

  2018, 49(02): 192. https://doi.org/10.16522/j.cnki.cjph.2018.02.012

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  Meloxicam (MLX) has been considered as one of the comparatively efficient antipyretic-antipyretics. However, its poor water solubility has limited the clinical applications. Recently, nanosuspension (NS) technology has been successfully used to tackle the formulation problem of poorly soluble drugs. To improve the dissolution velocity of MLX, the MLX nanosuspension was prepared by pH-dependent dissolving-precipitating/high speed shearing method. The process and formulation parameters were optimized by a single factor test with average particle size (PS), polydispersity index (PDI) and stability as the indexes. The optimal formulation and process were as follows: poloxamer 407(P407) and Tween-80 (T80) (1∶1, w/w) was used as the stabilizers for MLX nanosuspension and the ratio of the mixed stabilizers to MLX was 1∶2 (w/w); the speed and time of high speed shearing were 13 000 r/min and 2 min. The validation results of three batches of the optimal MLX nanosuspension showed that the particle size was within 200 nm and PDI was about 0.2, and the fluctuations of particle size and PDI were within 30 nm and 0.03 after storage for 7 d under room temperature. The results of scanning electron microscopy showed that MLX nanosuspension was irregular oval-shaped small particles with smooth surface. In pH 7.4 phosphate buffer, the dissolution at 5 min of the MLX nanosuspension was (91.68±3.26)％,whereas the coarse suspension of MLX was (50.45±3.13)％ at 60 min. The dissolution of MLX nanosuspension
  was significantly higher and faster than the coarse suspension, which indicated that MLX nanosuspensions had a significant increase in the extent of dissolution.
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  Preparation of the Lyophilized Pisum Sativum Agglutinin Anchored Poly(β-hydroxybutyrate) Nanoparticles Loaded with Docetaxel

  DONG Wenfeng1,2, DU Li2, LI Fei2, LI Fengqian3*

  2018, 49(02): 198. https://doi.org/10.16522/j.cnki.cjph.2018.02.013

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  The nanoparticles loaded with docetaxel (1) were prepared with poly(β-hydroxybutyrate) (PHB) as carriers by ultrasonic emulsification-solvent evaporation method, then coupled with pisum sativum agglutinin (PSA) after activated by glutaraldehyde to obtain the title nanoparticles (PSA-PHB-1-NPs). The modification efficiency of PSA was (50.58±0.15)％ determined by gel permeation chromatography-high performance liquid chromatography (GPC-HPLC)
  method. To improve the storage stability of the PSA-PHB-1-NPs colloid solution, the freeze-drying process was carried out. The effects of type and concentration of cryoprotectant, temperature and time of pre-freezing process and total freezedrying time on the properties of the lyophilized product were investigated. The optimal parameters were as follows: 2％ mannitol was used as the cryoprotectant and the colloid solution was pre-frozen for 12 h at -80 ℃, then dried for 48 h at -45 ℃ to obtain the lyophilized product. The results showed that the appearance, color and redispersibility of the lyophilized nanoparticles were satisfactory. There were no significant differences before and after lyophilization in terms of particle size and distribution, drug loading and entrapment efficiency. It showed that the lyophilized preparation of docetaxel-loaded PSA-anchored PHB nanoparticles would be reasonable and the freeze-drying process could be feasible,which was applicable for the freeze-drying of lectin-anchored drug-loading nanoparticles colloid solution and beneficial to
  solve the instability of liquid nanoparticles.
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  Preparation of Palbociclib Capsules and Establishment of a HPLC Method for Determination of Its Related Substances

  XU Haiqun1, ZHANG Chun1, XU Yuehong2, LIU Shunying1, HU Liping1, HU Wenhao1,2*

  2018, 49(02): 205. https://doi.org/10.16522/j.cnki.cjph.2018.02.014

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  Palbociclib is an inhibitor of CDK4/6 which studied by Pfizer. It is used in the treatment of female patients with ER positive breast cancer clinically. Because of its outstanding effect in clinical trials, the FDA approved its listing only in United States. There are no relevant reports of its preparation yet. Based on the excipients of palbociclib capsules (Ibrance) from Pfizer, the formulation of generic palbociclib capsules was screened by orthogonal test, finally the optimal formulation was as follows: palbociclib 7.5 g, microcrystalline cellulose 11 g, lactose monohydrate 5.6 g,sodium carboxymethyl starch 1.59 g, colloidal silica 0.265 g, magnesium stearate 0.545 g for 100 capsules. During the preparation, 3％ sodium carboxymethyl starch solution was used as adhesive for wet granulation, then the granules were dried at 60 ℃ and filled into the capsules. Meanwhile, a novel HPLC method for isolating and detecting five related
  substances of palbociclib was established. An InertSustain C18 column was used with ammonium acetate buffer (pH 5.7)∶acetonitrile as mobile phase by gradient elution. The detective wavelength was 225 nm. The method was validated with specificity, sensitivity, and durability. The results indicated that the novel HPLC method could be used for its related substances' analysis and quality control.
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  Effects of Paederia scandens Extract on the Acute Gouty Arthritis Caused by Monosodium Urate in Rats

  HU Han1,2, YUE Xinyi3, ZHOU Haifeng3, WU Tong3, SHEN Longhai1,2*

  2018, 49(02): 213. https://doi.org/10.16522/j.cnki.cjph.2018.02.015

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  Gouty arthritis (GA) is a disease characterized by joint pain, swelling, and deformity due to the crystallization of sodium urate. To explore the effect of Paederia scandens extract on gouty arthritis, the SD rats were divided into model (saline) group, low-, middle- and high-dose of Paederia scandens extract groups (50, 100, 200 mg/kg) and positive control (colchicine, 0.2 mg/kg) group. The acute gouty arthritis model was built by monosodium urate (MSU) crystal. Observations of the pathological changes of articular tissue and measurements of articular swelling degree as well as the expression of tumor necrosis factor α (TNF-α) and interleukin 1β (IL-1β) were carried out. Compared with the model group, different doses of Paederia scandens extract reduced the joint swelling induced by MSU in a timeand dose-dependent manner. Moreover, the effect of high-dose group of the extract was similar to that of the positive
  control, colchicine. The extract also reduced the expression of TNF-α and IL-1β, and improved the joint pathological damage. These results suggested that the Paederia scandens extract might be useful in the prevention and treatment of the acute gouty arthritis.
   
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  Determination of Related Substances of Betamethasone Acetate by HPLC

  DI Huifeng, GAO Ying, WU Haiyan, LI Weihua, DONG Chuanhai

  2018, 49(02): 219. https://doi.org/10.16522/j.cnki.cjph.2018.02.016

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  An HPLC method was established for the determination of the related substances in betamethasone acetate (1) and the quantification was achieved by self-control method with correction factors. A Zorbax SB-C18 column was used, with the mobile phase of acetonitrile∶water (35∶65), at the detection wavelength of 254 nm. The relative correction factors (RCFs) of the related substances were calculated with the slop of the linear equations so as to quantitatively determine the related substances. The results obtained by the proposed method were compared with those obtained by using the impurities reference standards to verify the method accuracy. As a result, the relative retention time of related substances were 0.64 (betamethasone, 2), 0.73 (dexamethasone, 3), 1.13 (dexamethasone acetate, 4), 1.23 (betamethasone acetate epoxide, 5), 1.73 (betamethasone-11,21-diacetate, 6), with RCFs of 0.95, 0.95, 1.00, 1.09 and 1.10, respectively. The results showed that there was no significant difference between the results of RCF method and those of calibration curves method. In addition, 1 and its related substances were effectively separated. Their calibration curves were linear in the concentration range of 0.1—10 μg/ml. Their recoveries for the related substances were 96.67％—99.68％, with RSDs of 0.37％—0.83％. This method was simple, efficient and accurate for the quantitation of the related substances in betamethasone acetate.
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  Structure Elucidation and Determination of Oxidative Impurity in Gefitinib Tablet by HPLC

  YE Guojian1,2, NIU Yawei1, HU Qiaohong1, QIN Linghao1*

  2018, 49(02): 224. https://doi.org/10.16522/j.cnki.cjph.2018.02.017

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  The degradation products of gefitinib through stressing test were traced. Among them, the oxidative impurity (named as oxidative impurity A) was synthesized, and then qualitatively and quantitatively determined. Its structure was elucidated by 1H NMR, 13C NMR and MS as 4-[(3-chloro-4-fluoro)phenylamino]-7-methoxy-6-[3-(morpholin-4-yl)propoxy] quinazolin-1-oxide. The HPLC method was optimized by changing the mobile phase ratio and pH value of aqueous phase. A Hypersil C18 column was used, with the mobile phase of acetonitrile∶1％ammonium acetate buffer (adjusted to pH 6.0 by acetate acid)(38∶62), at the detection wavelength of 253 nm. It was linear for oxidative impurity A in the range of 0.5—2.0 μg/ml, with LOQ of 0.15 μg/ml. It indicated that the oxidative
  impurity in gefitinib tablets could be effectively and accurately determined by the established HPLC method, which provided a reference for the establishment of the quality standard for gefitinib tablets.
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  Determination of 2,6-Ditertbutyl-4-methylphenol and 4-tert-Butylphenol in Esomeprazole Sodium for Injection by UPLC

  YE Ye, LIANG Wei, TAN Weilin, CAI Rong*

  2018, 49(02): 230. https://doi.org/10.16522/j.cnki.cjph.2018.02.018

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  An UPLC method was established for the simultaneous determination for 2,6-ditertbutyl-4-methylphenol (BHT) and 4-tert-butylphenol in esomeprazole sodium for injection. BHT and 4-tert-butylphenol was extracted by dichloromethane. A C18 column was used, with the mobile phase of methanol and water by linear gradient elution, at the detection wavelength of 280 nm. It was linear for BHT and 4-tert-butylphenol in the range of 0.4—10.0 μg/ml. The average recoveries were 81％—117％, with RSDs of 0.4％—6.6％. This work established a novel UPLC method for quantitative analysis of BHT and 4-tert-butylphenol. This method was simple, rapid and with good reproducibility, which could be widely used for migration determination of BHT and 4-tert-butylphenol in various formulations.
   
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  Determination of Nine Commonly Used Bacteriostatic Agents in 20 Kinds of Eye Drops by UPLC

  XIA Fangliang, WANG Yulin, LI Yijing, WANG Jianqiang

  2018, 49(02): 234. https://doi.org/10.16522/j.cnki.cjph.2018.02.019

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  A UPLC method was established for the determination of 9 commonly used bacteriostatic agents in eye drops. A Thermo Hypersil GOLD column was used, with the mobile phase of 0.5％ triethylamine (adjusted to pH 3.0 with phosphoric acid)∶methanol with linear gradient elution, at the detection wavelength of 260 nm. The qualitative analysis was carried out based on retention time and spectrum by UPLC-PDA. Under the above conditions, nine bacteriostatic agents were separated completely. Their recoveries were 98％—102％, with RSDs of 0.1％—0.4％. Four bacteriostatic agents, phenoxyethanol, benzalkonium bromide, ethyl p-hydroxybenzoate and benzalkonium chloride, were detected in 20 kinds of eye drops. This method is accurate, rapid and sensitive, which could be used as a reference method for the control of bacteriostatic agents in eye drops.
Pharmaceutical Management & Information
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  Pharmaceutical Management & Information

  The Spiral Price Reduction Effect of The Linkage between Health Insurance Payment Standard and Centralized Purchasing and Design on Buffer Threshold

  DING Jinxi,HAO Li,PAN Yue,HUANG Xinfeng,LI Wei

  2018, 49(02): 239. https://doi.org/10.16522/j.cnki.cjph.2018.02.020

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  Drug health insurance payment standard system can play a full role of price and expenditure control under its linkage with centralized purchasing. But at the same time its spiral decline may influence the welfare of the insured and negotiating motivation of medical institutions. The article aims to design buffer threshold of payment standard to maximally control negative effects and finally promote the smooth progress of health insurance payment reform, based
  on the study of the experiences of Australian and Taiwan, China, and the comprehensive evaluation of the linkage effect.
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  Pharmaceutical Management & Information

  Consensus Recommendations on Submitting Documentation for the Manufacturing and Controls for CAR-T Cell Products

  LI Jianping1, WANG Chong1, YU Lingli1, FU Qiuyan1, TAN Jianxin1, CHEN Yaoshui2*

  2018, 49(02): 248. https://doi.org/10.16522/j.cnki.cjph.2018.02.021

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  During recent years, the field of immune-cell therapy has been rapidly developed with the studies of immunological theory and technology. CAR-T therapy, firstly developed as a basic research, has gradually transformed into clinical application and is becoming one of the most promising therapeutic strategies in cancer treatment. In China, regulations on immune-cell therapy is still underway, which could hinder its further development and clinical application. Therefore, aiming at promoting CAR-T cell research and registration process, we harnessed the expertise of leading researchers, closely studied the key technologies and took reference from relevant regulatory experiences for the first draft of "Proposal Guidelines for Registration and Manufacturing of CAR-T Cell Products". In this review, we will discuss the consensus recommendations on submitting documentation for the manufacturing and controls for CAR-T cell products.
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  Pharmaceutical Management & Information

  Development Strategies of National Medicine Corporate Based on SWOT Analysis

  LI Bo1,2, SUN Lihua1*

  2018, 49(02): 257. https://doi.org/10.16522/j.cnki.cjph.2018.02.022

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  Pharmaceutical Management & Information

  Trends in Investment for Research and Development of AIDS Vaccines

  ZHANG Dongmei

  2018, 49(02): 262. https://doi.org/10.16522/j.cnki.cjph.2018.02.023

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  Through monitoring and analysis of twelve annual research reports(2005—2016) of resource tracking for HIV prevention R&D working group, the International AIDS Vaccine Initiative(IAVI)'s AIDS vaccine clinical trials database on April 3, 2017, the literature of scientific publications and the HIV research for prevention conference held in October 2016, we found that the hottest topic is the research of preventive AIDS vaccine. The most important investors in this field are the U.S. government and the Bill & Melinda Gates foundation. Because 28％ of funding for preventive AIDS vaccine R&D was allocated to basic research in 2015, 43 preventive AIDS vaccine candidates in clinical trials with various concepts and strategies were tested, HVTN 702(a modified version of RV144) is ongoing Phase Ⅲ clinical trial from November 2016 to the end of 2020, the phase Ⅱb AMP study is testing whether regular infusions of a potent broadly neutralizing antibody named VRC01 can provide protection against HIV, the recently discovered antibody N6 is the best in broadly neutralizing antibody class, new approaches that could spur the human body to produce HIV-blocking antibodies have been successful in mice mimicking the human immune system, various vaccine concepts and strategies shared on 2016 HIV research for prevention conference, the European Commission granted over US$24 millions to form the European HIV Vaccine Alliance to develop innovative preventive and therapeutic AIDS vaccine concepts in 2016, we conclude that AIDS vaccine research is still in its discovery phase.