CN106572649A - 用于创新治疗的药物的包装 - Google Patents
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Abstract
本发明涉及一种产品,其包含:a)至少一种选自重组核酸、单一细胞和单一组织的物质,所述物质存放于初级容器中;和b)次级容器,其中存放所述的初级容器,所述的次级容器由隔热材料构成。本发明还涉及使用所述产品运输选自重组核酸、单一细胞和单一组织的物质的方法。
Description
本发明涉及一种产品,其包含:
a)至少一种选自重组核酸、分离的细胞和分离的组织的物质,所述物质存在于初级容器中;和
b)次级容器,其中存在所述的初级容器,所述的次级容器由隔热材料构成。
生物物质,具体地讲是创新治疗药物,通常由活体材料或由活体产生的材料构成,如核酸、分离的细胞或分离的组织。这些物质相对脆弱,需要特定的保藏和储存条件以保持其活性。
这些物质的有效性经常受到物流问题,具体地讲是运输条件问题的阻碍。例如干细胞,如脐带血细胞,一旦收集通常会冷冻保存,特别是保存在细胞库中,并且在需要的情况下,可以运送到医院。这种冷冻保存方法通常将温度冷却至约-196℃来保存细胞或组织,这具有某些风险。例如,细胞可能由于冷冻或在重新加热到环境温度期间受到损伤。这些风险对于维持生物物质的活性是特别严重的,因为所述物质必须保持其完整性。此外,为了其有效性,所用的细胞和分离的组织必须是活的。
因此,这些生物物质的运输必须在尽可能短的时间内进行。具体地讲,利用干冰或液氮在夜间来运送形成了规范,并且必须进行额外的注意以控制整个运送过程中的温度。然而,这种做法并不能消除风险。此外,所用的运输费用通常是昂贵的,并且在长距离运输上不是非常实用。
因此,需要可用的产品和方法,其使得生物物质的运输是切实可行和可靠的,并确保维持该生物物质的完整性和生存力。
本发明可以满足这种需要。这是因为本发明的产品和使用该产品的运输方法为生物物质随着时间推移的保存提供了监测以及良好的条件。这是因为,如实施例中所示,运输可以在48h的时间段内进行,同时保持设定的温度,即2-8℃或34-38C°。
因此,本发明涉及一种产品,其包含:
a)至少一种选自重组核酸、分离的细胞和分离的组织的物质,所述物质存在于初级容器中;和
b)次级容器,其中存在所述的初级容器,所述的次级容器由隔热材料构成。
本发明还涉及一种方法,其用于运输选自重组核酸、分离的细胞和分离的组织的物质,包含以下步骤:
i)将所述物质放置在初级容器中;
ii)将在步骤i)中获得的所述初级容器置于次级容器中,从而获得本发明的产品;和
iii)封闭在步骤ii)中获得的次级容器。
本发明的产品和运输方法涉及生物物质,其可以被描述为活组织检查或创新治疗药物。
具体地讲,这些物质选自:
-基因治疗药物;
-体细胞治疗药物;
-由细胞工程或组织工程产生的药物;和
-组合的创新治疗药物。
基因治疗药物通常由整合在合适工具(载体、质粒、病毒颗粒等类型的工具)中的重组核酸构成。
其它上述药物通常由分离的细胞或组织构成。
因此,所述物质优选地选自重组核酸、分离的间充质干细胞、分离的造血干细胞和免疫活性细胞。
造血干细胞能够以同种异体或自体同源的方式使用。
具体地讲,当抗原是肿瘤抗原时,免疫活性细胞具体选自同种异体T淋巴细胞、NK细胞、细胞毒性T淋巴细胞、肿瘤浸润淋巴细胞(TIL)和抗原敏化树突细胞。
也可以使用一些细胞类型,例如在神经变性疾病情况下的胎儿神经元、替代器官移植物的胰岛或肝细胞、或者在修复医学中的成纤维细胞、角质细胞、软骨细胞、内皮细胞或成肌细胞。
因此,本发明的产品包含至少一种物质a),其选自重组核酸、分离的细胞和分离的组织。在本发明中该物质也称为“生物物质”,存在于初级容器中。初级容器整体存在于次级容器b)中,所述次级容器由隔热材料构成。
构成次级容器的隔热材料优选聚合物,优选为塑料聚合物。优选的塑料聚合物选自聚丙烯、聚四氟乙烯(PTFE)、聚乙烯、聚碳酸酯、聚对苯二甲酸乙酯(PET)、聚氯乙烯(PVC)、聚偏氟乙烯及其混合物。构成次级容器更优选的隔热材料是聚丙烯。
优选的次级容器是盒或箱。
优选的初级容器选自袋、管、瓶、小瓶、注射器、微管和孔板。正是该初级容器与物质接触。
在初级容器内,生物物质可以配制在生物学上可接受的培养基中。“生物学上可接受的培养基”应理解为与所述物质相容的培养基。这种培养基具体地讲是细胞培养基,例如包含血清如人血清的培养基。
按照本发明优选的可选方式,本发明的产品存在于包含热调节装置的三级容器中。所述三级容器优选由热调节装置和隔热包装组成。本发明的产品还可以包含在任何其它类型的三级包装中,例如聚苯乙烯包装或真空绝热板(VIP)类型的包装。
本发明的产品优选包含温度探头,优选有线的温度探头。该探头优选在与初级容器接触的次级容器中。这种探头使得在不打开相关容器的情况下,可以监测到最接近点的生物物质温度。
本发明的产品优选涂覆一层抵抗X射线的材料,优选为一层铅。这种抵抗X射线的材料使得可以保护生物物质,特别是在飞机运输期间。
优选地,本发明的产品的初级容器、次级容器和在适宜情况下的三级容器是密封的。因此,它们各自确保了生物物质的隔热性,并且特别是确保生物物质以可靠的方式运输。
本发明的另一个主题是一种方法,其用于运输选自重组核酸、分离的细胞和分离的组织的物质,包括以下步骤:
i)将所述物质放置在初级容器中;
ii)将在步骤i)中获得的所述初级容器置于次级容器中,从而获得本发明的产品;和
iii)封闭在步骤ii)中获得的次级容器。
本发明的运输方法可以优化处理和温度维持,并且可以针对能够由冷却或加热手段导致的外部影响而保持产品(也就是生物物质)的完整性。
本发明的产品的运输可以在温度维持下进行72h。
优选地,该方法使得物质的运输可以以稳定的方式进行至少24h的时间,优选至少48h。
“以稳定的方式”进行的运输应理解为,在生物物质没有实质性变质的情况下进行运输,所述生物物质保持其物理完整性和功能性。“无实质性变质”是指该物质的损坏最多为重量的5%。
现在将使用以下实施例举例说明本发明,这些实施例不是限制性的。
实施例1:疫苗的运输
生物物质在这个例子中指的是疫苗,在不同的条件下运输。
在运输期间评估温度的维持情况。
产品温度下降的时间的测定(所述产品在环境温度下稳定并引入到配备有温度调
节装置的箱中,所有东西都放置在符合ST96A设置的室中)
1-1三级容器(箱)
包装:箱R11
外部尺寸:394×310×521mm
工作尺寸:171×267×224mm
隔热材料:聚氨酯泡沫体和VIP板
隔板:由塑料纤维制成的隔板
1-2温度调节装置
名称:Rigid Snowgam 10/05
布置:单独
包装数量:1
尺寸:180×145×35mm
包装重量:670g
名称:Rigid Snowgam 12/05
布置:单独
包装数量:2
尺寸:230×180×35mm
包装重量:890g
名称:TRU(热调节装置)
布置:单独
数量:1
尺寸:300×200×150mm
重量:7.38kg
2-温度测量
使用的热按钮和位置:
热按钮编号:THB 03位置:环境温度
热按钮编号:THB 08位置:产品
热按钮编号:THB 10位置:箱内部
3-测试条件
产品类型:置于尺寸为43×23×133mm的纸板包装中的空注射器(初级容器)。
将注射器置于尺寸为200×190×110mm的聚丙烯盒(次级容器)内。将牛皮纸放置在疫苗周围以使其固定。
4-装载条件
温度:+21(±3℃)
Rigid Snowgam 10/05包装的布置:在底部,在+5℃
Rigid Snowgam 12/05包装的布置:每个长边1个,在+5℃
TRU的布置:在顶部,在-21℃
塑料纤维隔板的布置:在TRU和包含产品的聚丙烯盒之间。
R11箱装有不同的冷的蓄电池以及TRU和聚丙烯盒(已固定);上述所有东西都放置在测试室中24小时(设置的前24小时)。在这24小时后,打开箱并将疫苗(已在环境温度下稳定)加入到该装载中。
ST96A设置:
ST96A
温度 | 持续时间 |
+22℃ | 3H |
+28℃ | 4H |
+22℃ | 9H |
+28℃ | 8H |
+40℃ | 4H |
+28℃ | 3H |
+22℃ | 9H |
+25℃ | 8H |
+22℃ | 3H |
+28℃ | 4H |
+22℃ | 9H |
+28℃ | 8H |
+40℃ | 4H |
+28℃ | 3H |
+22℃ | 9H |
+25℃ | 8H |
结论
在该配置中,在环境温度下将疫苗引入到配备有1个Rigid Snowgam 10/05、2个Rigid Snowgam 12/05和1个TRU的箱中,在测试30分钟后疫苗的温度达到8℃。
随后,在该配置中,该箱能够将疫苗保持在+2℃到+8℃至少96小时。
实施例2:次级容器在空的情况下的隔热性能的验证实验
目的是证明在非常低的温度下,聚丙烯包装(即次级容器)可以减少热冲击,该热冲击可能潜在地对选自重组核酸、分离的细胞和分离的组织的物质的完整性产生不利影响。
另一个目的是证明在运输之后,当由聚丙烯制成的次级包装已经恢复到环境温度时,后者减缓温度的上升,从而可以更确保对物质的处理。
测试如下:
将聚丙烯包装在<-60℃的冰箱中放置10h。将探头A(Sensitech TempTale 4DryIce型探头,其可测量范围从+60℃至-110℃)置于包装内部,另一个探头B(相同类型)置于包装外部。
该测试在温度调节到23℃的房间中进行。
该测试开始于2014年4月17日18:51,并于2014年4月18日10:07结束。
结果:
探头A放置在包装内:
温度下降:
最大值:22.5℃,在17/04/2014 18:51
目标冷冻值:<-60.0℃,在17/04/2014 18:59
从最大值(环境温度)下降到目标冷冻值(冰箱的环境温度)的时间:8分钟
温度上升:
最小值:-77.5℃,在18/04/2014 09:51
高于0℃的值(2.6℃),在18/04/2014 09:57
最大值:22.9℃,在18/04/2014 10:07
从最小值(冰箱的环境温度)上升到最大值(环境温度)的时间:16分钟
从最小值(冰箱的环境温度)上升到第一个高于0℃值的时间:6分钟
探头B放置在包装外部:
下降温度:
最大值:22.5℃,在17/04/2014 18:51
目标冷冻值:<-60.0℃,在17/04/2014 18:55
从最大值(环境温度)下降到目标冷冻值(冰箱的环境温度)的时间:4分钟
温度上升:
最小值:-77.9℃,在18/04/2014 09:51
高于0℃的值(10.6℃),在18/04/2014 09:54
最大值:22.7℃,在18/04/2014 10:00
从最小值(冰箱的环境温度)上升到最大值(环境温度)的时间:9分钟
从最小值(冷冻箱的环境温度)上升到第一个高于0℃值的时间:3分钟。
结论:
已经发现,聚丙烯包装(次级容器)提供了更温和的温度下降以及更缓慢的温度上升。具体地讲,所有参数平均乘以2。
实施例3:验证次级容器隔热性能的实验
将两个分别装有25ml水的50ml Duran Schott烧瓶置于冷室中以获得温度。
随后将第一个烧瓶放置在等温运输袋中,并用预先冷冻至-80℃的两个凝胶袋包围。
第二个烧瓶首先放入聚丙烯包装(次级容器)中,然后放入等温运输袋中,并用预先冷冻至-80℃的两个凝胶袋包围。
每个等温袋配备一个有线探头,其中一个探头放置在等温包装内部。使用的探头是Sensitech TempTale 4Dry Ice型探头,可测量范围从+60℃到-110℃。
等温包装预先放置在冷室中,以便也处于该温度下。
目的是证明聚丙烯包装可以减少由放置在冷藏车中已经冷冻过长的凝胶袋引起的过度冷冻的影响,冷冻过长的凝胶袋可能潜在地对选自重组核酸、分离的细胞和分离的组织的物质的完整性产生不利影响,或者在运输期间使温度读数失真。
结果:
测试开始于2014年4月22日16:36,于2014年4月23日9:33结束。
与直接放置在两个凝胶袋中间的探头测量的温度相比,观察到聚丙烯包装内部的探头测量的温度下降幅度小得多。
温度下降的差异约为-20℃。
该测试可以得出结论:放置在预先冷冻至-80℃的两个凝胶袋之间10h并在等温运输袋内解冻约4h的聚丙烯包装可以将温度维持在+2℃和+8℃之间约13h。
结论:
发现相比未放置在聚丙烯包装中的相同产品,聚丙烯包装提供了小得多的温度下降。
实施例4:验证次级容器隔热性能的实验
该方案的目的在于测试运输所取出的样品的进程和条件。使用缓冲溶液或水来模拟取出的组织或细胞。
本报告的目的是描述医院和创新治疗药物生产地点之间的组织/细胞转移。为了模拟所取出的组织/细胞的转移,进行了两个测试:
-一个使用PBS制剂的缓冲液,在2014年5月6日,温度为+34/+38℃;
-另一个使用水,在2014年9月17日,温度为+34/+38℃。
在每种情况下,目的是在控制的温度下,保证从取出到递送的运输期间烧瓶的完整性。
使用材料:
缓冲液或水:
预先在医院现场制备模拟取出样品的制剂缓冲液(第一个测试)。因此,准备一个含有该缓冲液的50ml Sarstedt管,并于2014年5月6日10:00放置在+37℃培养箱中。
Sarstedt管 | |
产品名称 | PBS |
描述 | 制剂缓冲液 |
尺寸 | 直径2cm高度10cm |
体积 | 50ml |
标记 | NA |
预先在医院现场制备模拟取出样品的水(第二个测试)。因此,准备一个含有该水的50ml Sarstedt管,并于2014年9月17日10:00放置在南特大学医院中心(UHC)的+37℃培养箱中。
Sarstedt管 | |
描述 | 水 |
尺寸 | 直径2cm高度10cm |
体积 | 50ml |
标记 | NA |
外部包装:
外部包装由具有包裹的箱组成。
制备该包装以保持+34/+38℃的温度。
包装方法:
将含有PBS或水的Sarstedt管置于容量为1升的95kPa塑料袋(次级包装)中,接着置于聚丙烯盒(200×190×110mm)中,然后置于外部包装(394×310×521mm)中。
探头:
两个探头用于该运输测试:
-插入包装中的探头,设置在+34/+38℃;
-热按钮探头,设置为每3分钟测量间隔进行记录。温度+34/+38℃。
第一次测试的结果如下:
测试管在良好条件下到达并且在运输期间维持在设定的温度点。
第二次试验的结果如下:
测试管在良好条件下到达并且在运输期间维持在设定的温度点。
总之,这些运输操作符合:所运输的材料可以保持在良好的温度下至少48h。
Claims (10)
1.一种产品,其包含:
a)至少一种选自重组核酸、分离的细胞和分离的组织的物质,所述物质存在于初级容器中;和
b)次级容器,其中存在所述的初级容器,所述的次级容器由隔热材料构成。
2.如权利要求1所述的产品,其特征在于,其存在于包含热调节装置的三级容器中。
3.如权利要求1或2所述的产品,其特征在于,构成所述次级容器的隔热材料是聚合物,其选自聚丙烯、聚四氟乙烯、聚乙烯、聚碳酸酯、聚对苯二甲酸乙酯、聚氯乙烯、聚偏氟乙烯以及它们的混合物。
4.如权利要求1至3中任一项所述的产品,其特征在于,所述初级容器选自袋、管、瓶、小瓶、注射器、微管和孔板。
5.如权利要求1至4中任一项所述的产品,其特征在于,所述物质选自重组核酸、分离的间充质干细胞、分离的造血干细胞和免疫活性细胞。
6.如权利要求1至5中任一项所述的产品,其特征在于,其包含温度探头,优选为有线的温度探头。
7.如权利要求1至6中任一项所述的产品,其特征在于,所述产品涂覆有一层抵抗X射线的材料,优选为一层铅。
8.如权利要求1至7中任一项所述的产品,其特征在于,所述初级容器、次级容器和在适宜情况下的三级容器是密封的。
9.一种运输选自重组核酸、分离的细胞和分离的组织的物质的方法,包括以下步骤:
i)将所述物质放置在初级容器中;
ii)将在步骤i)中获得的所述初级容器放置在次级容器中,从而获得如权利要求1至8中任一项所述的产品;和
iii)封闭在步骤ii)中获得的次级容器。
10.如权利要求9所述的方法用于保持所述物质在外部影响下的完整性的用途。
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FR1456935A FR3023714A1 (fr) | 2014-07-18 | 2014-07-18 | Emballage de medicament de therapie innovante |
FR1456935 | 2014-07-18 | ||
PCT/FR2015/051977 WO2016009162A1 (fr) | 2014-07-18 | 2015-07-17 | Emballage de médicament de thérapie innovante |
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JP2017523968A (ja) | 2017-08-24 |
US20170156313A1 (en) | 2017-06-08 |
WO2016009162A1 (fr) | 2016-01-21 |
FR3023714A1 (fr) | 2016-01-22 |
EP3169153A1 (fr) | 2017-05-24 |
EP3169153B1 (fr) | 2019-04-03 |
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