WO2022257545A1 - 一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂 - Google Patents

一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂 Download PDF

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WO2022257545A1
WO2022257545A1 PCT/CN2022/082383 CN2022082383W WO2022257545A1 WO 2022257545 A1 WO2022257545 A1 WO 2022257545A1 CN 2022082383 W CN2022082383 W CN 2022082383W WO 2022257545 A1 WO2022257545 A1 WO 2022257545A1
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liquid preparation
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monoclonal antibody
sars
fully human
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吴小丽
潘勇兵
唐杰
邓小杰
桂芳
王炯
杜洪桥
王泽鋆
李新国
段凯
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武汉生物制品研究所有限责任公司
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    • C—CHEMISTRY; METALLURGY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • the application belongs to the field of antibody pharmaceutical preparations, and in particular, relates to a liquid preparation of a recombinant fully human monoclonal antibody against SARS-CoV-2.
  • SARS-CoV-2 is a novel coronavirus that has caused a global pandemic since its outbreak in 2019, seriously threatening global public health.
  • SARS-CoV-2 is a novel coronavirus that has caused a global pandemic since its outbreak in 2019, seriously threatening global public health.
  • Active immune protection through vaccination takes several weeks to achieve protective effect, while antibodies against SARS-CoV-2 can provide immediate passive immunity. Immunity, while also providing effective protection to immunocompromised populations.
  • the antibody preparation developed by this application contains the active ingredient "recombinant fully human anti-new coronavirus monoclonal antibody", which is used for short-term prevention and treatment of SARS-CoV-2 infection, and is the structure and function of the antibody during production, transportation and storage Stability is guaranteed.
  • This application first relates to a liquid preparation of recombinant fully human monoclonal antibody 2B11 against SARS-CoV-2, the preparation includes fully human anti-new coronavirus monoclonal antibody 2B11, buffer, and the buffer contains Containing stabilizers, surfactants, and optionally isotonic regulators, the solvent of the liquid preparation is water for injection, and the pH of the liquid preparation is 5.5-6.1.
  • the buffer is 10-50mM histidine buffer, preferably 20mM histidine buffer, with a pH of 5.5-6.1;
  • the content of the fully human anti-new coronavirus monoclonal antibody 2B11 is 10-100 mg/mL, preferably 20 mg/ml.
  • the stabilizer is 50-150mM arginine, preferably 125mM arginine.
  • the surfactant is 0.005%-0.02% polysorbate 20, preferably 0.01% polysorbate 20.
  • the isotonic regulator is 15-40mM sodium chloride, preferably 20-30mM sodium chloride, more preferably 27mM sodium chloride.
  • the present application also relates to the application of the liquid preparation in the preparation of reagents for detecting or inhibiting SARS-CoV-2 virus.
  • the present application also relates to the application of the liquid preparation in the preparation of medicines, and the medicines are medicines for preventing and/or treating diseases caused by SARS-CoV-2 virus infection.
  • the drug is an injection.
  • the antibody used in the following examples is a fully humanized 2B11 monoclonal antibody.
  • sequence structure of this antibody please refer to our company's previous application CN202010567918.X.
  • the formulation needs to be stable under freeze-thaw conditions, including size-exclusion gel chromatography (SEC-HPLC), non-reducing capillary gel electrophoresis (non-reducing CE-SDS), and charge changes, which can be determined by ion-exchange chromatography (CEX- HPLC) detection.
  • SEC-HPLC size-exclusion gel chromatography
  • CEX- HPLC charge changes
  • CEX- HPLC ion-exchange chromatography
  • the sample to be tested was diluted with deionized water to a protein concentration of 1 mg/ml.
  • Non-reducing capillary gel electrophoresis (non-reducing CE-SDS) to detect charge variants the detection steps are as follows:
  • Sample dilution the sample was diluted to 1 mg/ml with sample buffer.
  • Result processing the area normalization method was used for integration, and the purity of the main peak was calculated as the percentage of the corrected peak area of the IgG main peak to the sum of all corrected peak areas.
  • Solution A 20mM MES: Weigh 3.9g of MES, add 950ml of water to dissolve, adjust the pH value to 7.5 ⁇ 0.05 with 5M NaOH, then dilute to 1L with deionized water, filter with 0.22 ⁇ m membrane for later use;
  • Solution B 20mM MES+500mM NaCl: Weigh 3.9g of MES, 29.25g of NaCl, add 950ml of deionized water to dissolve, adjust the pH value to 5.5 ⁇ 0.05 with 5M NaOH, dilute to 1L with deionized water, filter with 0.22 ⁇ m membrane spare.
  • the following table shows that under the condition of 10-60mg/ml concentration, the monoclonal antibody was frozen and thawed at least 5 times (freezing and thawing conditions: -70°C for 2 days, room temperature for 2 days) without degradation (non-reducing CE-SDS), charge variation body (CEX-HPLC) and aggregation (SEC-HPLC).
  • the following table shows the quality inspection results of each preparation of high temperature-1 sampling on the 5th day of high temperature, high temperature-2 sampling on the 10th day of high temperature, and high temperature-3 sampling on the 30th day of high temperature (formulation 2B11 from top to bottom in the table -01 ⁇ 2B11-17).
  • the following table shows the quality inspection results of each formulation under high-temperature shaking conditions (high-temperature shaking conditions: 40°C, 200rmp) (formulations 2B11-01 to 2B11-17 from top to bottom in the table).
  • Embodiment 2 formula protective agent density measurement
  • Polysorbate 20 0.1g
  • the density of the protective agent was 1.0023g/L.

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Abstract

本申请属于抗体药物制剂领域，具体涉及一种抗SARS-CoV-2的重组全人源单克隆抗体(2B11)的液体制剂，其中包括全人源抗新冠病毒单克隆抗体2B11、缓冲液，所述的缓冲液中还包含稳定剂、表面活性剂、以及可选地包含等渗调节剂，所述的液体制剂的溶剂为注射用水，所述的液体制剂的pH为5.5-6.1。

Description

一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂
相关申请的交叉引用
本申请要求于2021年06月07日提交中国专利局的申请号为202110633655.2、名称为“一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请属于抗体药物制剂领域，具体的，涉及一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂。
背景技术
SARS-CoV-2是一种新型冠状病毒，自2019年爆发以来已引起全球大流行，严重威胁到全球公共健康。截至目前，虽然已有上市疫苗，但每天全球感染的人数仍在增加，通过接种疫苗产生主动免疫保护，需要数周才能达到保护效力，而针对SARS-CoV-2的抗体则能提供即时的被动免疫，同时对免疫功能低下的人群也能提供有效的保护。
通过前期的研究已经证实，本公司研发的具有独立知识产权的针对SARS-CoV-2的重组全人源单克隆抗体2B11(CN202010567918.X)，能特异性结合SARS-CoV-2表面抗原，从而阻止新冠病毒进一步感染受体细胞，达到保护的作用。对于高风险人群，抗SARS-CoV-2的重组全人源单克隆抗体可以提供短期的即时预防；对于感染后人群，可以通过注射被动免疫的抗体降低重症的风险。
发明内容
本申请所开发的抗体制剂，包含活性成分“重组全人源抗新冠病毒单克隆抗体”，用于短期预防和治疗SARS-CoV-2感染，为抗体生产、运输和保存过程中的结构和功能稳定性提供保障。
本申请首先涉及一种针对SARS-CoV-2的重组全人源单克隆抗体2B11的液体制剂，所述制剂包括全人源抗新冠病毒单克隆抗体2B11、缓冲液，所述的缓 冲液中还包含稳定剂、表面活性剂、以及可选地包含等渗调节剂，所述的液体制剂的溶剂为注射用水，所述的液体制剂的pH为5.5-6.1。
所述的缓冲液为10～50mM组氨酸盐缓冲液，优选20mM组氨酸盐缓冲液，pH为5.5-6.1；
所述的液体制剂中，包括全人源抗新冠病毒单克隆抗体2B11的含量为10～100mg/mL，优选为20mg/ml。
所述的稳定剂为50-150mM的精氨酸，优选125mM的精氨酸。
所述的表面活性剂为0.005％-0.02％的聚山梨酯20，优选0.01％的聚山梨酯20。
所述的等渗调节剂为15-40mM的氯化钠，优选20-30mM的氯化钠，更优选27mM的氯化钠。
本申请还涉及所述的液体制剂在制备检测或抑制SARS-CoV-2病毒的试剂中的应用。
本申请还涉及所述的液体制剂在制备药物中的应用，所述的药物为预防和/或治疗因SARS-CoV-2病毒感染导致的疾病的药物。
优选的，所述的药物为注射剂。
本申请的有益效果在于：
为SARS-CoV-2病毒的检测、鉴定及感染后的治疗提供了新的候选药物。
附图说明
图1、单克隆抗体2B11液体制剂处方开发过程中非还原CE-SDS结果。
图2、单克隆抗体2B11液体制剂处方开发过程中SEC-HPLC结果。
图3、单克隆抗体2B11液体制剂处方开发过程中CEX-HPLC结果。
图4、单克隆抗体2B11液体制剂处方开发过程中亚可见颗粒检测结果。
图5、单克隆抗体2B11液体制剂处方的冻融研究结果。
具体实施方式
若未特别说明，以下实施例中所用的技术手段均为本领域技术人员所熟知的常规手段，所有试剂耗材均为市售商品。
下述实施例中所使用的抗体为全人源化的2B11单抗，该抗体的序列结构参见本公司在先申请CN202010567918.X。
制剂配方如下表所示
样品编号 主要配方组成
2B11-01 组氨酸，山梨醇，tween20
2B11-02 组氨酸，精氨酸，tween20
2B11-03 组氨酸，精氨酸，泊洛沙姆
2B11-04 组氨酸，甘露醇，tween80
2B11-05 组氨酸，精氨酸，tween80
2B11-06 组氨酸，Gly，tween80
2B11-07 组氨酸，精氨酸，tween80
2B11-08 组氨酸，Gly，tween80
2B11-09 组氨酸，Gly，tween20
2B11-10 组氨酸，山梨醇，tween20
2B11-11 组氨酸，山梨醇，泊洛沙姆
2B11-12 组氨酸，甘露醇，tween80
2B11-13 组氨酸，山梨醇，tween80
2B11-14 组氨酸，甘露醇，tween80
2B11-15 组氨酸，山梨醇，泊洛沙姆
2B11-16 组氨酸，Gly，泊洛沙姆
2B11-17 组氨酸，甘露醇，tween20
实施例1、抗体制剂的冻融研究
配方需要在冻融条件下稳定，稳定包括分子排阻凝胶色谱(SEC-HPLC)、非还原毛细管凝胶电泳(非还原CE-SDS)、以及电荷的改变，可通过离子交换色谱(CEX-HPLC)检测。。
(一)分子排阻凝胶色谱(SEC-HPLC)检测抗体降解情况，检测步骤：
(1)流动相溶液的配制(0.1mol/L PB+0.1mol/L Na 2SO 4+0.05％NaN 3)：称取Na 2SO 414.2g，NaH 2PO 4·H 2O 6.9g，Na 2HPO 4·12H 2O 17.9g，NaN 30.5g，加800ml水溶解后，用氢氧化钠溶液调pH至6.7，定容至1L，0.22μm膜过滤待用。
(2)待测样品用去离子水稀释至蛋白浓度为1mg/ml。
(3)洗脱方式：100％流动相等度洗脱。
(4)样品分析：用流动相以1.0ml/min流速平衡高效液相色谱系统至基线平衡后进样分析。
(5)结果处理：采用面积归一化法进行积分。
(二)非还原毛细管凝胶电泳(非还原CE-SDS)检测电荷变异体，检测步骤如下：
(1)样品稀释：将样品用样品缓冲液稀释至1mg/ml。
(2)取95μl稀释样品，加入5μl的烷基化溶液，混匀，6000rpm离心1min；
(3)70℃加热5min，立即冷水浴5min；
(4)6000rpm离心1min，吸取90μl入上样管，采用安捷伦G7100毛细管电泳仪分析。
(5)结果处理：采用面积归一化法进行积分，以IgG主峰的修正峰面积占所有修正峰面积之和的百分比计算主峰的纯度。
(三)离子交换色谱(CEX-HPLC)检测步骤凝聚情况，检测步骤如下：
(1)流动相配制
A液：20mM MES：称取MES 3.9g，加水950ml溶解，用5M NaOH调pH值至7.5±0.05，再用去离子水定容至1L，0.22μm膜过滤备用；
B液：20mM MES+500mM NaCl：称取MES 3.9g，NaCl 29.25g，加去离子水950ml溶解，用5M NaOH调pH值至5.5±0.05，用去离子水定容至1L，0.22μm膜过滤备用。
(2)样品处理：将样品用去离子水稀释至1mg/ml。
(3)色谱过程：用100％A液以1.0ml/min流速平衡高效液相色谱系统至基线平衡。进样后依照梯度洗脱方法进行洗脱，并在30分钟内记录色谱图及数据。
(4)结果处理：按照面积归一化法进行积分，溶剂峰不进行积分。
下表展示了在10-60mg/ml浓度条件下，单抗冻融至少5次(冻融条件：-70℃2天、室温2天)而没有出现降解(非还原CE-SDS)、电荷变异体(CEX-HPLC)和聚集情况(SEC-HPLC)。
Figure PCTCN2022082383-appb-000001
下表展示高温-1为高温第5天取样、高温-2为高温第10天取样、高温-3为高温第30天取样的各个制剂的质量检测结果(表中自上而下依次为配方2B11-01～2B11-17)。
Figure PCTCN2022082383-appb-000002
下表展示了高温振摇条件下各个制剂的质量检测结果(高温振摇的条件：40℃，200rmp)(表中自上而下依次为配方2B11-01～2B11-17)。
Figure PCTCN2022082383-appb-000003
实施例2、配方保护剂密度测定
经过实施例1的对比数据，最终确定优选处方配置如下，并进一步测定配方保护剂的密度：
(1)1L保护剂
组氨酸：3.103g；
精氨酸：21.775g；
氯化钠：1.58g；
聚山梨酯20：0.1g；
(2)用900ml注射用水溶解，盐酸调pH5.8，并用容量瓶定容至1L。
(3)称重，根据ρ＝m/V计算保护剂的密度。
结果：保护剂的密度为1.0023g/L。
最后需要说明的是，以上实施例仅用于帮助本领域技术人员理解本申请的实质，不用于限定本申请的保护范围。

Claims (8)

  1. 一种抗SARS-CoV-2的重组全人源单克隆抗体2B11的液体制剂，其特征在于，
    所述制剂包括全人源抗新冠病毒单克隆抗体2B11、缓冲液，
    所述的缓冲液中还包含稳定剂、表面活性剂、以及可选地包含等渗调节剂，所述的液体制剂的溶剂为注射用水，所述的液体制剂的pH为5.5-6.1。
  2. 根据权利要求1所述的液体制剂，其特征在于，所述的缓冲液为10～50mM组氨酸盐缓冲液，优选20mM组氨酸盐缓冲液，pH为5.5-6.1。
  3. 根据权利要求1所述的液体制剂，其特征在于，所述的液体制剂中，全人源单克隆抗体2B11的含量为10～100mg/mL，优选为20mg/ml。
  4. 根据权利要求1-3任一所述的液体制剂，其特征在于，所述的稳定剂为50-150mM的精氨酸，优选125mM的精氨酸。
  5. 根据权利要求1-3任一所述的液体制剂，其特征在于，所述的表面活性剂为0.005％-0.02％的聚山梨酯20，优选0.01％的聚山梨酯20。
  6. 根据权利要求1-3任一所述的液体制剂，其特征在于，所述的等渗调节剂为15-40mM的氯化钠，优选20-30mM的氯化钠，更优选27mM的氯化钠。
  7. 权利要求1-6任一所述的液体制剂在制备检测或抑制SARS-CoV-2病毒的试剂中的应用。
  8. 权利要求1-6任一所述的液体制剂在制备药物中的应用，所述的药物为预防和/或治疗因SARS-CoV-2病毒感染导致的疾病的药物；优选的，所述的药物为注射剂。
PCT/CN2022/082383 2021-06-07 2022-03-23 一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂 WO2022257545A1 (zh)

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